CHAMGAP

Five alternative caesarean surgical techniques × Six-week maternal death or morbidity composite: evidence checklist

Select a review item to see its details.
Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Efficacy comparison and presentation of stored materialWhat are the selected question and original verdict?Required
The question is “Reduced six-week maternal death or morbidity composite” and links to the complete existing verdict record. Original D34, Good and H/R1/I2/E0/B0/C0 are retained.
This is a display draft from the stored summary. The original contains some information, but The existing candidate history is preserved. No new subquestion or statement of absent/inherited scores is created. User review of the table remains pending.
The distinction between the selected question and original D34 verdict/assessment axes
A proposed later production record distinguishing the selected question from the existing verdict record. No new investigation, calculation or trial was performed here.
2 Partly verified Full text not readStored summary read N02 · Efficacy comparison and presentation of stored materialWhich events are included in the six-week maternal death or morbidity composite?Required
The existing research explanation describes a prespecified primary composite of clinical events such as death, readmission, reoperation and transfusion. It is not transferred to a reduction in each component or mortality alone.
This is a display draft from the stored summary. The original contains some information, but Complete component definitions, severity/adjudication/duplicate handling and component-specific events/denominators are unverified. User review of the table remains pending.
The composite definition, including clinical events such as death, readmission, reoperation and transfusion
Proposed later material reporting the composite and its components separately. No new investigation, calculation or trial was performed here.
3 Partly verified Full text not readStored summary read N03 · Efficacy comparison and presentation of stored materialWhat are the population, sites, countries and recruitment scope?Required
Original CORONIS enrolled 15,935 women at 19 sites in seven countries. Actual ages, emergency/planned surgery, baseline risks and exclusions are not filled in to generalize to every caesarean population.
This is a display draft from the stored summary. The original contains some information, but Eligibility/exclusions, surgical indications/baseline risk, site composition and recruitment periods are unverified. User review of the table remains pending.
The 15,935 women, 19 sites, seven countries and actual eligibility/baseline risk
Proposed material distinguishing the original population from other settings/populations. No new investigation, calculation or trial was performed here.
4 Partly verified Full text not readStored summary read N04 · Efficacy comparison and presentation of stored materialHow were the five comparisons allocated in the fractional factorial design?Required
The original was an open randomized nonregular fractional factorial design, with each site participating in three of five comparisons. It is not assumed that every woman participated in all five.
This is a display draft from the stored summary. The original contains some information, but Site/participant factor allocation, possible combinations and comparison-specific analysis populations are unverified. User review of the table remains pending.
The distinction between the 2×2×2×2×2 nonregular fractional factorial design and three pairs per site
Proposed fractional factorial reporting specifying comparison populations and sharing. No new investigation, calculation or trial was performed here.
5 Partly verified Full text not readStored summary read N05 · Efficacy comparison and presentation of stored materialWhat was the original six-week result for blunt versus sharp abdominal entry?Required
Original six-week blunt versus sharp abdominal entry RR (95% CI): 1.03 (0.91–1.17). The original direction and interval are preserved, without transferring the effect to another technique, component or period.
This is a display draft from the stored summary. The original contains some information, but Event counts, denominators, models/adjustment and prespecified important differences for this comparison are unverified. User review of the table remains pending.
Comparison direction, RR/95% CI and composite outcome for blunt versus sharp abdominal entry
Proposed later material separating this comparison’s composite/component outcomes and intervals. No new investigation, calculation or trial was performed here.
6 Partly verified Full text not readStored summary read N06 · Efficacy comparison and presentation of stored materialWhat was the original six-week result for exteriorized versus intra-abdominal uterine repair?Required
Original six-week exteriorized versus intra-abdominal uterine repair RR (95% CI): 0.96 (0.84–1.08). The original direction and interval are preserved, without transferring the effect to another technique, component or period.
This is a display draft from the stored summary. The original contains some information, but Event counts, denominators, models/adjustment and prespecified important differences for this comparison are unverified. User review of the table remains pending.
Comparison direction, RR/95% CI and composite outcome for exteriorized versus intra-abdominal uterine repair
Proposed later material separating this comparison’s composite/component outcomes and intervals. No new investigation, calculation or trial was performed here.
7 Partly verified Full text not readStored summary read N07 · Efficacy comparison and presentation of stored materialWhat was the original six-week result for single- versus double-layer uterine closure?Required
Original six-week single- versus double-layer uterine closure RR (95% CI): 0.96 (0.85–1.08). The original direction and interval are preserved, without transferring the effect to another technique, component or period.
This is a display draft from the stored summary. The original contains some information, but Event counts, denominators, models/adjustment and prespecified important differences for this comparison are unverified. User review of the table remains pending.
Comparison direction, RR/95% CI and composite outcome for single- versus double-layer uterine closure
Proposed later material separating this comparison’s composite/component outcomes and intervals. No new investigation, calculation or trial was performed here.
8 Partly verified Full text not readStored summary read N08 · Efficacy comparison and presentation of stored materialWhat was the original six-week result for peritoneal closure versus nonclosure?Required
Original six-week peritoneal closure versus nonclosure RR (95% CI): 1.06 (0.94–1.20). The original direction and interval are preserved, without transferring the effect to another technique, component or period.
This is a display draft from the stored summary. The original contains some information, but Event counts, denominators, models/adjustment and prespecified important differences for this comparison are unverified. User review of the table remains pending.
Comparison direction, RR/95% CI and composite outcome for peritoneal closure versus nonclosure
Proposed later material separating this comparison’s composite/component outcomes and intervals. No new investigation, calculation or trial was performed here.
9 Partly verified Full text not readStored summary read N09 · Efficacy comparison and presentation of stored materialWhat was the original six-week result for chromic catgut versus polyglactin-910 sutures?Required
Original six-week chromic catgut versus polyglactin-910 suture RR (95% CI): 0.90 (0.78–1.04). The original direction and interval are preserved, without transferring the effect to another technique, component or period.
This is a display draft from the stored summary. The original contains some information, but Event counts, denominators, models/adjustment and prespecified important differences for this comparison are unverified. User review of the table remains pending.
Comparison direction, RR/95% CI and composite outcome for chromic catgut versus polyglactin-910 sutures
Proposed later material separating this comparison’s composite/component outcomes and intervals. No new investigation, calculation or trial was performed here.
10 Partly verified Full text not readStored summary read N10 · Efficacy comparison and presentation of stored materialDo nonsignificance and the original null verdict establish equivalence or exclude benefit?Required
The original describes five null comparisons but records D34 because there is no benefit-exclusion boundary. CIs including 1 are not extended to perfect equivalence, exclusion of every small difference or an individual safety guarantee.
This is a display draft from the stored summary. The original contains some information, but Prespecified minimum important effects/equivalence margins and the size of rare-outcome effects that can be excluded are unverified. User review of the table remains pending.
Original D34/E0/C0 and the absence of a benefit-exclusion boundary
Proposed material specifying uncertainty about rare or small differences. No new investigation, calculation or trial was performed here.
11 Unverified Full text not readStored summary read N11 · Efficacy comparison and presentation of stored materialCan absolute events and absolute differences be established from RRs?Required
The existing verdict rationale says absolute differences were not reverse-calculated from RRs because the abstract lacked absolute event counts. No new event counts, absolute differences, individual risks or hypothetical examples are created.
This is a display draft from the stored summary. Required information is currently unverified. Original event counts, control risks, comparison-specific assessment denominators and absolute intervals are unverified. User review of the table remains pending.
The distinction between absent absolute event counts in the original abstract and relative RRs
Proposed later material reporting absolute and relative outcomes from their respective original sources. No new investigation, calculation or trial was performed here.
12 Partly verified Full text not readStored summary read N12 · Efficacy comparison and presentation of stored materialAre the full 15,935 women and each factor’s denominator the same?Required
The 15,935 women are the original total trial population. They are not used as an identical denominator for all five comparisons, as the observed population for every event/safety outcome, or as new total participants.
This is a display draft from the stored summary. The original contains some information, but Actual denominators and missing/excluded observations by comparison, group, component and timepoint are unverified. User review of the table remains pending.
Total randomized participants and factor-, component- and follow-up-specific denominators
Proposed reporting linking each outcome’s denominator to its factor/timepoint. No new investigation, calculation or trial was performed here.
13 Partly verified Full text not readStored summary read N13 · Efficacy comparison and presentation of stored materialHow are shared participants, factors, groups, events and interactions distinguished?Required
The five factors and composite/component outcomes are overlapping conditions of the same CORONIS trial. Different comparisons are not counted as new independent trials, and absence of interaction is not certified.
This is a display draft from the stored summary. The original contains some information, but Model factors/interactions, site effects, repeated-event handling and shared populations are unverified. User review of the table remains pending.
Fractional factorial overlap, repeated observations/interactions and independent comparisons
Proposed reporting separating shared structure from factor-specific results. No new investigation, calculation or trial was performed here.
14 Partly verified Full text not readStored summary read N14 · Efficacy comparison and presentation of stored materialWhat is the scope of the original allocation concealment, open surgery and ITT statements?Required
The existing research explanation cites a secure central telephone randomisation service, open surgery and ITT for B0. This is not inherited as a current review of allocation, blinding or missingness, or certification that every event adjudication was unbiased.
This is a display draft from the stored summary. The original contains some information, but Sequence generation, site deviations, assessor blinding and ITT exclusions/missingness details are unverified. User review of the table remains pending.
Central telephone randomization, unmasked surgery, ITT and actual implementation
Proposed reporting separating open surgery from event ascertainment/missingness. No new investigation, calculation or trial was performed here.
15 Partly verified Full text not readStored summary read N15 · Efficacy comparison and presentation of stored materialWhat differs in common care, sites and surgical conditions?Required
The original five comparisons concern incision and closure techniques. Common/group-specific anaesthesia, prophylactic antibiotics, surgeon experience and other care are not assumed to have been identical.
This is a display draft from the stored summary. The original contains some information, but Co-interventions/deviations, surgeons/sites, actual technique exposure and adherence are unverified. User review of the table remains pending.
Factor contrasts, other surgical/anaesthetic/drug treatments and site conditions
Proposed later material distinguishing technique comparisons from other treatment contributions. No new investigation, calculation or trial was performed here.
16 Partly verified Full text not readStored summary read N16 · Efficacy comparison and presentation of stored materialWhat is the six-week observation window and follow-up/missingness specification?Required
The original primary endpoint is maternal death or morbidity through six weeks. Long-term maternal/subsequent-pregnancy outcomes are not merged into that six-week endpoint.
This is a display draft from the stored summary. The original contains some information, but Visit windows, follow-up methods, missingness/attrition, event ascertainment and ITT missing-data handling are unverified. User review of the table remains pending.
The six-week maternal composite, observation timing/duration and the period after it ends
Proposed reporting separating short-term endpoints from long-term follow-up. No new investigation, calculation or trial was performed here.
17 Partly verified Full text not readStored summary read N17 · Efficacy comparison and presentation of stored materialWhat are the hierarchy and multiplicity rules for five primary comparisons and other outcomes?Required
The existing research explanation states agreement between ISRCTN31089967 and the six-week primary endpoint. It does not establish that all long-term, component or subgroup results were prespecified confirmatory primary outcomes.
This is a display draft from the stored summary. The original contains some information, but Protocols/SAPs, multiplicity, interactions/subgroups and registration changes have not been read. User review of the table remains pending.
The original prespecified primary composite, five comparisons, plans and multiplicity
Proposed material presenting planned and actually reported outcomes separately. No new investigation, calculation or trial was performed here.
18 Partly verified Full text not readStored summary read N18 · Efficacy comparison and presentation of stored materialIs the 2016 follow-up a new independent trial?Required
The original evidence preserves the 2013 report and 2016 follow-up of the same trial together. The two PMIDs, timepoints and outcomes are not added as independent replications or new total participants.
This is a display draft from the stored summary. The original contains some information, but Unique trial/participant and independent replication totals are not established and remain null. User review of the table remains pending.
The 2013/2016 reports and the same CORONIS trial/population
Proposed later linkage distinguishing report counts from study families/follow-up participants. No new investigation, calculation or trial was performed here.
19 Partly verified Full text not readStored summary read N19 · Efficacy comparison and presentation of stored materialHow are the three-year report, mean 3.8 years and 13,153 women (84%) preserved?Required
The original counterview’s three-year report describes 13,153 women (84%) followed for a mean 3.8 years. Attrition counts/rates are not calculated from these values and the full 15,935 women, and original values are not corrected.
This is a display draft from the stored summary. The original contains some information, but The follow-up-eligible denominator, contact/selection/attrition and factor-specific analysis counts/missingness are unverified. User review of the table remains pending.
Report designation, actual mean follow-up and original follow-up counts/proportion
Proposed long-term reporting specifying how original numbers relate to populations/timepoints. No new investigation, calculation or trial was performed here.
20 Partly verified Full text not readStored summary read N20 · Efficacy comparison and presentation of stored materialAre representative long-term outcomes the same as the six-week composite?Required
Original representative long-term values: abdominal hernia 0.66 (0.39–1.11), infertility 0.91 (0.71–1.18), maternal death 0.78 (0.46–1.32), infertility 0.80 (0.61–1.06), and subsequent-pregnancy uterine rupture 3.05 (0.32–29.29). Each original factor contrast is retained, without transfer to the six-week composite effect.
This is a display draft from the stored summary. The original contains some information, but Population, events, denominators, timepoints, prespecified plans and CI interpretation criteria for each long-term outcome are unverified. User review of the table remains pending.
Abdominal hernia, infertility, maternal death and subsequent-pregnancy uterine rupture versus six-week outcomes
Proposed later material reporting uncertainty separately for each long-term outcome. No new investigation, calculation or trial was performed here.
21 Partly verified Full text not readStored summary read N21 · Harm-information gaps supplementing the efficacy tableWhat does the original interval for rare uterine rupture not establish?Supplementary
Original uterine rupture RR 3.05 (0.32–29.29) concerns a long-term subsequent-pregnancy outcome. It is not newly judged as confirmation of six-week harm, zero risk, exclusion of all small differences or evidence for individual technique choice.
This is a display draft from the stored summary. The original contains some information, but The relevant subsequent-pregnancy denominator, events/missingness, original prespecified hierarchy and harm-exclusion boundary are unverified. User review of the table remains pending.
Catgut/polyglactin subsequent-pregnancy uterine rupture RR 3.05 (0.32–29.29)
Proposed material separately reporting rare harms and uncertainty in subsequent pregnancies. No new investigation, calculation or trial was performed here.
22 Partly verified Full text not readStored summary read N22 · Efficacy comparison and presentation of stored materialIs the case 2641 azithromycin citation replication of the surgical technique evidence?Required
The existing context citation links a Chamgap article about a different drug intervention. It is not transferred into a direct CORONIS incision/closure result, independent replication or the same population.
This is a display draft from the stored summary. The original contains some information, but That article and primary paper have not been read here and are not used as direct technique comparison material. User review of the table remains pending.
A context link for a different infection-prevention drug versus direct technique comparisons
Proposed relationship records separating technique and infection-prevention drug questions. No new investigation, calculation or trial was performed here.
23 Partly verified Full text not readStored summary read N23 · Efficacy comparison and presentation of stored materialAre public/nonprofit funding, COI and actual research roles the same?Required
Original funding is from the UK MRC and WHO, public/nonprofit sources. It is not extended to absence of all product support, employee authors or COI, or to current independence certification.
This is a display draft from the stored summary. The original contains some information, but Supply/manufacture, institution/author roles, analysis/writing contributions and complete COI disclosures have not been read. User review of the table remains pending.
MRC/WHO funding, original I2 axis and product/author/control roles
Proposed reporting distinguishing funding type from research control/contributions. No new investigation, calculation or trial was performed here.
24 Partly verified Full text not readStored summary read N24 · Efficacy comparison and presentation of stored materialDoes ISRCTN31089967 and historical agreement mean the registration was read here?Required
Original ISRCTN31089967 and historical primary-endpoint agreement wording are preserved. The identifier or historical wording does not establish current access, registration-change checks or plan verification.
This is a display draft from the stored summary. The original contains some information, but Registration, changes, protocols and SAPs have not been read, and access has not been attempted. User review of the table remains pending.
The stored registration text versus actual reading of registration/plans
Proposed material linking registration versions with actually reported outcomes. No new investigation, calculation or trial was performed here.
25 Partly verified Full text not readStored summary read N25 · Harm-information gaps supplementing the efficacy tableWhat are the 144 serious adverse events and 26 possibly related events?Supplementary
The existing safety explanation describes 144 serious adverse events and 26 possibly intervention-related events. These are not calculated/changed into participant counts, incidence rates, factor-specific harm differences or established causality.
This is a display draft from the stored summary. The original contains some information, but Safety participants/time, duplicate events, factor-specific groups, ascertainment/classification and severity details are unverified. User review of the table remains pending.
The distinction between original event counts/possible relatedness and participants, rates and causality
Proposed reporting distinguishing events from people and factor-specific safety outcomes. No new investigation, calculation or trial was performed here.
26 Partly verified Full text not readStored summary read N26 · Harm-information gaps supplementing the efficacy tableIs absence of an established consistent harm advantage the same as overall safety?Supplementary
The original records Good safety and no established consistent harm advantage for a specific comparison. It is not extended to all techniques/patients, zero long-term risk, equal safety or individual suitability.
This is a display draft from the stored summary. The original contains some information, but Factor-specific safety effects/intervals, vulnerable groups, missingness and long-term event comparisons are unverified. User review of the table remains pending.
The original safety summary and gaps in factor-specific, vulnerable-group and long-term harms
Proposed material distinguishing short-/long-term harms and vulnerable populations. No new investigation, calculation or trial was performed here.
27 Partly verified Full text not readStored summary read N27 · Efficacy comparison and presentation of stored materialCan the findings be extended to operating time, convenience or superiority in other populations?Required
The existing advertising interpretation says operating time/technical convenience must not be extended to reduced maternal death or morbidity. No guidance on the user’s technique/suture choice, surgery or suitability is created.
This is a display draft from the stored summary. The original contains some information, but Direct comparisons of techniques/time or other populations/periods are separate from this question. User review of the table remains pending.
Technical convenience versus maternal clinical outcomes and exposure history
Proposed material linking technical processes to patient clinical outcomes while distinguishing them. No new investigation, calculation or trial was performed here.
28 Partly verified Full text not readStored summary read N28 · Efficacy comparison and presentation of stored materialHow much of the original summary, external papers and Chamgap links was actually read?Required
The full stored summary was used for production and marked as summary read. Only initial/follow-up PubMed URLs and the relative case 2641 URL are preserved; external summaries/articles, registration/plans and COI material have not been read.
This is a display draft from the stored summary. The original contains some information, but No link/click testing, external identity/full-text comparison or screen inspection was performed in the source preparation. User review of the table remains pending.
The full stored summary, initial/follow-up PMIDs, Chamgap links and unread external material
Proposed records separating full-text/summary acquisition from actual reading scope for each material. No new investigation, calculation or trial was performed here.
29 Partly verified Full text not readStored summary read N29 · Efficacy comparison and presentation of stored materialHow are KO/EN, the original verdict, dates, correction history/empty values and historical cross-checks preserved?Required
Korean/English articles, D34, Good, assessment axes, correction history, empty values, original reference date and historical cross-check/abstract wording are preserved. They are not inherited as a new verdict or completed correction/translation review.
This is a display draft from the stored summary. The original contains some information, but No current full-text comparison, new clinical update/correction or completed content review. User review of the table remains pending.
Original D34, Good, assessment axes, 2026-08-26 and existing empty values
Proposed records distinguishing original preservation from separate update/correction events. No new investigation, calculation or trial was performed here.
30 Partly verified Full text not readStored summary read N30 · Efficacy comparison and presentation of stored materialAre condition preservation, application, case production and review separate records?Required
Condition preservation/application, case production and completed review are separate records. Review of the existing content is incomplete and is distinguished from production.
This is a display draft from the stored summary. The original contains some information, but User review is incomplete. The original preparation did not reread or review saved output, run checks/tests, or inspect links/screens. User review of the table remains pending.
Production sequence and incomplete user review
Proposed later records separately documenting production and user review/corrections. No new investigation, calculation or trial was performed here.
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30 itemsWhat the statuses mean

Assessment scope

Stored-material review date
Not recorded
Original evidence cut-off
2026-08-26
Scope actually checked
Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean
This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population
CORONIS: 15,935 women at 19 sites in seven countries; each site participated in three of five pairs. Factor-specific, analysis and safety denominators are unverified
Ingredient, formulation and route
The historical comparison of five alternative caesarean surgical techniques; this is not guidance on performing or choosing surgery
Dose
Not recorded
Comparator
Original comparisons: blunt/sharp entry; exteriorized/intra-abdominal repair; single/double layers; peritoneal closure/nonclosure; catgut/polyglactin-910
Measured outcome
Six-week maternal death or morbidity composite, distinguished from its components and long-term outcomes
Duration
Six-week primary composite; the same trial’s 2016 three-year report and mean 3.8-year follow-up provide separate outcome context
Questions outside this scope
Transferring all five original six-week RRs/CIs to the same effect, component or period, or to mortality alone; Extending nonsignificance or the original D34/E0/C0 to equivalence, exclusion of all small benefits/harms, zero risk or an individual guarantee; Calculating events, denominators, absolute differences/intervals, hypothetical numbers or new effects from RRs; Using all 15,935 women as every comparison/component/safety denominator, or adding factors, timepoints or groups as new independent trials/total participants; Converting the original 13,153 women (84%), three-year report or mean 3.8 years into new rates, attrition, corrections or six-week effects; Counting initial/follow-up CORONIS reports as independent replication, or transferring an azithromycin context citation into direct technique evidence; Inheriting historical central telephone allocation, open surgery, ITT, registration agreement, cross-checks or B0/I2 as current QA, full-text reading or independent certification; Calculating/judging participant counts, rates, factor-specific harms, established causality or overall safety from the original 144 events/26 possibly related events; Using technical convenience, operating time or rare long-term intervals as guidance on clinical effects, surgical choice/performance or suture suitability; New subclaims/verdict splits, numbers, grades, reassessment, searches/APIs or treatment/procedure recommendations

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · CORONIS Collaborative Group. Lancet. 2013. PMID: 23721753.

PubMed

Material type
2×2×2×2×2 nonregular fractional factorial open randomized trial
Materials actually read
Summary read; external material unread
Findings recorded in the stored summary
The five original six-week RRs/95% CIs, D34, Good and H/R1/I2/E0/B0/C0 are preserved. Nonsignificance/original null results are not extended to equivalence or exclusion of every small benefit/harm; events and absolute differences are not calculated. MRC/WHO, central telephone allocation, open surgery, ITT and prespecified primary-endpoint statements are historical and do not establish current summary/registration/COI/QA verification.
Record level
Outcome wording in the stored summary
Study overlap and independent replication
CORONIS-ISRCTN31089967: S01 CORONIS 2013/PMID23721753 and S02 CORONIS 2016/PMID27155903 are the initial six-week and mean 3.8-year follow-up reports of the same CORONIS trial. Original 15,935 women, long-term 13,153 women (84%), three pairs per site, five factors/repeated timepoints and composite/component/safety outcomes are not added as new independent trials/total participants. Unique clinical totals remain null. CONTEXT-2919-AZITHROMYCIN2641: S03 Chamgap case 2641 azithromycin is a context link to an article about a different infection-prevention drug. It is not included as direct CORONIS technique evidence, the same population or independent replication. That article has not been read here.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored evidence and bibliography summaryStored fileStored summarySummary readOnly the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review.
Paper, abstract and full textPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration and change historyPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Prespecified study protocolPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
SAP and prespecified analysis planPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Original funding, product support, employee-author and conflict-of-interest disclosuresPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S02 · CORONIS Collaborative Group. Lancet. 2016. PMID: 27155903.

PubMed

Material type
2×2×2×2×2 nonregular fractional factorial open randomized trial
Materials actually read
Summary read; external material unread
Findings recorded in the stored summary
Original 13,153 women (84%) and mean 3.8 years; representative long-term RRs: abdominal hernia .66 (.39–1.11), infertility .91 (.71–1.18), maternal death .78 (.46–1.32), infertility .80 (.61–1.06), and subsequent-pregnancy uterine rupture 3.05 (.32–29.29). Original contrasts/outcomes and unverified denominators are retained, without transfer to six-week effects, independent replication or calculated risk/independence/attrition rates.
Record level
Outcome wording in the stored summary
Study overlap and independent replication
CORONIS-ISRCTN31089967: S01 CORONIS 2013/PMID23721753 and S02 CORONIS 2016/PMID27155903 are the initial six-week and mean 3.8-year follow-up reports of the same CORONIS trial. Original 15,935 women, long-term 13,153 women (84%), three pairs per site, five factors/repeated timepoints and composite/component/safety outcomes are not added as new independent trials/total participants. Unique clinical totals remain null. CONTEXT-2919-AZITHROMYCIN2641: S03 Chamgap case 2641 azithromycin is a context link to an article about a different infection-prevention drug. It is not included as direct CORONIS technique evidence, the same population or independent replication. That article has not been read here.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored evidence and bibliography summaryStored fileStored summarySummary readOnly the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review.
Paper, abstract and full textPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration and change historyPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Prespecified study protocolPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
SAP and prespecified analysis planPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Original funding, product support, employee-author and conflict-of-interest disclosuresPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S03 · Chamgap case 2641: adjunctive azithromycin × Caesarean infection

Official source

Material type
A different-drug article linked only in a citation; no direct surgical technique evidence row
Materials actually read
Summary read; external material unread
Findings recorded in the stored summary
The existing context citation’s wording about a different infection-prevention drug and its relative URL are preserved. Existing path-verification wording is historical and does not mean the link/article was checked here.
Record level
Outcome wording in the stored summary
Study overlap and independent replication
CORONIS-ISRCTN31089967: S01 CORONIS 2013/PMID23721753 and S02 CORONIS 2016/PMID27155903 are the initial six-week and mean 3.8-year follow-up reports of the same CORONIS trial. Original 15,935 women, long-term 13,153 women (84%), three pairs per site, five factors/repeated timepoints and composite/component/safety outcomes are not added as new independent trials/total participants. Unique clinical totals remain null. CONTEXT-2919-AZITHROMYCIN2641: S03 Chamgap case 2641 azithromycin is a context link to an article about a different infection-prevention drug. It is not included as direct CORONIS technique evidence, the same population or independent replication. That article has not been read here.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored evidence and bibliography summaryStored fileStored summarySummary readOnly the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review.
Paper, abstract and full textPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

Report counts versus independent study counts

CORONIS-ISRCTN31089967: S01 CORONIS 2013/PMID23721753 and S02 CORONIS 2016/PMID27155903 are the initial six-week and mean 3.8-year follow-up reports of the same CORONIS trial. Original 15,935 women, long-term 13,153 women (84%), three pairs per site, five factors/repeated timepoints and composite/component/safety outcomes are not added as new independent trials/total participants. Unique clinical totals remain null. CONTEXT-2919-AZITHROMYCIN2641: S03 Chamgap case 2641 azithromycin is a context link to an article about a different infection-prevention drug. It is not included as direct CORONIS technique evidence, the same population or independent replication. That article has not been read here.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · What are the selected question and original verdict?
Required materials and conditions
The distinction between the selected question and original D34 verdict/assessment axes
Conditions for verification
The relevant source material and analysis scope for The distinction between the selected question and original D34 verdict/assessment axes must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes The distinction between the selected question and original D34 verdict/assessment axes to connect the evidence needed for the selected question with the available material.
Referenced methods
Question clarification principles in M03 §3.1 and §3.2.1–3.2.4; Detailed separation rules are Chamgap design; M04 §4.5 and §4.6.3; Limits of this conversion follow the user-defined scope and Chamgap design
N02 · Which events are included in the six-week maternal death or morbidity composite?
Required materials and conditions
The composite definition, including clinical events such as death, readmission, reoperation and transfusion
Conditions for verification
The relevant source material and analysis scope for The composite definition, including clinical events such as death, readmission, reoperation and transfusion must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes The composite definition, including clinical events such as death, readmission, reoperation and transfusion to connect the evidence needed for the selected question with the available material.
Referenced methods
M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary
N03 · What are the population, sites, countries and recruitment scope?
Required materials and conditions
The 15,935 women, 19 sites, seven countries and actual eligibility/baseline risk
Conditions for verification
The relevant source material and analysis scope for The 15,935 women, 19 sites, seven countries and actual eligibility/baseline risk must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes The 15,935 women, 19 sites, seven countries and actual eligibility/baseline risk to connect the evidence needed for the selected question with the available material.
Referenced methods
M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design
N04 · How were the five comparisons allocated in the fractional factorial design?
Required materials and conditions
The distinction between the 2×2×2×2×2 nonregular fractional factorial design and three pairs per site
Conditions for verification
The relevant source material and analysis scope for The distinction between the 2×2×2×2×2 nonregular fractional factorial design and three pairs per site must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes The distinction between the 2×2×2×2×2 nonregular fractional factorial design and three pairs per site to connect the evidence needed for the selected question with the available material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M08 §8.1–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application
N05 · What was the original six-week result for blunt versus sharp abdominal entry?
Required materials and conditions
Comparison direction, RR/95% CI and composite outcome for blunt versus sharp abdominal entry
Conditions for verification
The relevant source material and analysis scope for Comparison direction, RR/95% CI and composite outcome for blunt versus sharp abdominal entry must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes Comparison direction, RR/95% CI and composite outcome for blunt versus sharp abdominal entry to connect the evidence needed for the selected question with the available material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application
N06 · What was the original six-week result for exteriorized versus intra-abdominal uterine repair?
Required materials and conditions
Comparison direction, RR/95% CI and composite outcome for exteriorized versus intra-abdominal uterine repair
Conditions for verification
The relevant source material and analysis scope for Comparison direction, RR/95% CI and composite outcome for exteriorized versus intra-abdominal uterine repair must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes Comparison direction, RR/95% CI and composite outcome for exteriorized versus intra-abdominal uterine repair to connect the evidence needed for the selected question with the available material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application
N07 · What was the original six-week result for single- versus double-layer uterine closure?
Required materials and conditions
Comparison direction, RR/95% CI and composite outcome for single- versus double-layer uterine closure
Conditions for verification
The relevant source material and analysis scope for Comparison direction, RR/95% CI and composite outcome for single- versus double-layer uterine closure must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes Comparison direction, RR/95% CI and composite outcome for single- versus double-layer uterine closure to connect the evidence needed for the selected question with the available material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application
N08 · What was the original six-week result for peritoneal closure versus nonclosure?
Required materials and conditions
Comparison direction, RR/95% CI and composite outcome for peritoneal closure versus nonclosure
Conditions for verification
The relevant source material and analysis scope for Comparison direction, RR/95% CI and composite outcome for peritoneal closure versus nonclosure must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes Comparison direction, RR/95% CI and composite outcome for peritoneal closure versus nonclosure to connect the evidence needed for the selected question with the available material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application
N09 · What was the original six-week result for chromic catgut versus polyglactin-910 sutures?
Required materials and conditions
Comparison direction, RR/95% CI and composite outcome for chromic catgut versus polyglactin-910 sutures
Conditions for verification
The relevant source material and analysis scope for Comparison direction, RR/95% CI and composite outcome for chromic catgut versus polyglactin-910 sutures must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes Comparison direction, RR/95% CI and composite outcome for chromic catgut versus polyglactin-910 sutures to connect the evidence needed for the selected question with the available material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application
N10 · Do nonsignificance and the original null verdict establish equivalence or exclude benefit?
Required materials and conditions
Original D34/E0/C0 and the absence of a benefit-exclusion boundary
Conditions for verification
The relevant source material and analysis scope for Original D34/E0/C0 and the absence of a benefit-exclusion boundary must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes Original D34/E0/C0 and the absence of a benefit-exclusion boundary to connect the evidence needed for the selected question with the available material.
Referenced methods
M04 §4.6.3 and M15 §15.3.1–15.3.3; Status separation is Chamgap design; M15 §15.3.1–15.3.3; Chamgap application
N11 · Can absolute events and absolute differences be established from RRs?
Required materials and conditions
The distinction between absent absolute event counts in the original abstract and relative RRs
Conditions for verification
The relevant source material and analysis scope for The distinction between absent absolute event counts in the original abstract and relative RRs must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes The distinction between absent absolute event counts in the original abstract and relative RRs to connect the evidence needed for the selected question with the available material.
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application
N12 · Are the full 15,935 women and each factor’s denominator the same?
Required materials and conditions
Total randomized participants and factor-, component- and follow-up-specific denominators
Conditions for verification
The relevant source material and analysis scope for Total randomized participants and factor-, component- and follow-up-specific denominators must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes Total randomized participants and factor-, component- and follow-up-specific denominators to connect the evidence needed for the selected question with the available material.
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application
N13 · How are shared participants, factors, groups, events and interactions distinguished?
Required materials and conditions
Fractional factorial overlap, repeated observations/interactions and independent comparisons
Conditions for verification
The relevant source material and analysis scope for Fractional factorial overlap, repeated observations/interactions and independent comparisons must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes Fractional factorial overlap, repeated observations/interactions and independent comparisons to connect the evidence needed for the selected question with the available material.
Referenced methods
Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application
N14 · What is the scope of the original allocation concealment, open surgery and ITT statements?
Required materials and conditions
Central telephone randomization, unmasked surgery, ITT and actual implementation
Conditions for verification
The relevant source material and analysis scope for Central telephone randomization, unmasked surgery, ITT and actual implementation must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes Central telephone randomization, unmasked surgery, ITT and actual implementation to connect the evidence needed for the selected question with the available material.
Referenced methods
M08 §8.1–8.2.3; Chamgap application; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application
N15 · What differs in common care, sites and surgical conditions?
Required materials and conditions
Factor contrasts, other surgical/anaesthetic/drug treatments and site conditions
Conditions for verification
The relevant source material and analysis scope for Factor contrasts, other surgical/anaesthetic/drug treatments and site conditions must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes Factor contrasts, other surgical/anaesthetic/drug treatments and site conditions to connect the evidence needed for the selected question with the available material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application
N16 · What is the six-week observation window and follow-up/missingness specification?
Required materials and conditions
The six-week maternal composite, observation timing/duration and the period after it ends
Conditions for verification
The relevant source material and analysis scope for The six-week maternal composite, observation timing/duration and the period after it ends must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes The six-week maternal composite, observation timing/duration and the period after it ends to connect the evidence needed for the selected question with the available material.
Referenced methods
M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design
N17 · What are the hierarchy and multiplicity rules for five primary comparisons and other outcomes?
Required materials and conditions
The original prespecified primary composite, five comparisons, plans and multiplicity
Conditions for verification
The relevant source material and analysis scope for The original prespecified primary composite, five comparisons, plans and multiplicity must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes The original prespecified primary composite, five comparisons, plans and multiplicity to connect the evidence needed for the selected question with the available material.
Referenced methods
Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design; M08 Table 8.2.a and M04 §4.6.3; Chamgap application
N18 · Is the 2016 follow-up a new independent trial?
Required materials and conditions
The 2013/2016 reports and the same CORONIS trial/population
Conditions for verification
The relevant source material and analysis scope for The 2013/2016 reports and the same CORONIS trial/population must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes The 2013/2016 reports and the same CORONIS trial/population to connect the evidence needed for the selected question with the available material.
Referenced methods
Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application
N19 · How are the three-year report, mean 3.8 years and 13,153 women (84%) preserved?
Required materials and conditions
Report designation, actual mean follow-up and original follow-up counts/proportion
Conditions for verification
The relevant source material and analysis scope for Report designation, actual mean follow-up and original follow-up counts/proportion must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes Report designation, actual mean follow-up and original follow-up counts/proportion to connect the evidence needed for the selected question with the available material.
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design
N20 · Are representative long-term outcomes the same as the six-week composite?
Required materials and conditions
Abdominal hernia, infertility, maternal death and subsequent-pregnancy uterine rupture versus six-week outcomes
Conditions for verification
The relevant source material and analysis scope for Abdominal hernia, infertility, maternal death and subsequent-pregnancy uterine rupture versus six-week outcomes must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes Abdominal hernia, infertility, maternal death and subsequent-pregnancy uterine rupture versus six-week outcomes to connect the evidence needed for the selected question with the available material.
Referenced methods
M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design
N21 · What does the original interval for rare uterine rupture not establish?
Required materials and conditions
Catgut/polyglactin subsequent-pregnancy uterine rupture RR 3.05 (0.32–29.29)
Conditions for verification
The relevant source material and analysis scope for Catgut/polyglactin subsequent-pregnancy uterine rupture RR 3.05 (0.32–29.29) must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Supplementary
Application exceptions
Supplements gaps in harm data for the selected six-week maternal death or morbidity composite question. Original serious adverse events/Good safety are not extended to safety of every technique/patient, harm causality/rates or exclusion of long-term differences. No guidance on choosing, performing or determining suitability of surgery/devices/sutures is created.
Why this condition is needed
This item distinguishes Catgut/polyglactin subsequent-pregnancy uterine rupture RR 3.05 (0.32–29.29) to connect the evidence needed for the selected question with the available material.
Referenced methods
M15 §15.3.1–15.3.3; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretation boundary. M19 principles are referenced; no official causality tool was run
N22 · Is the case 2641 azithromycin citation replication of the surgical technique evidence?
Required materials and conditions
A context link for a different infection-prevention drug versus direct technique comparisons
Conditions for verification
The relevant source material and analysis scope for A context link for a different infection-prevention drug versus direct technique comparisons must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes A context link for a different infection-prevention drug versus direct technique comparisons to connect the evidence needed for the selected question with the available material.
Referenced methods
Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design
N23 · Are public/nonprofit funding, COI and actual research roles the same?
Required materials and conditions
MRC/WHO funding, original I2 axis and product/author/control roles
Conditions for verification
The relevant source material and analysis scope for MRC/WHO funding, original I2 axis and product/author/control roles must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes MRC/WHO funding, original I2 axis and product/author/control roles to connect the evidence needed for the selected question with the available material.
Referenced methods
Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design
N24 · Does ISRCTN31089967 and historical agreement mean the registration was read here?
Required materials and conditions
The stored registration text versus actual reading of registration/plans
Conditions for verification
The relevant source material and analysis scope for The stored registration text versus actual reading of registration/plans must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes The stored registration text versus actual reading of registration/plans to connect the evidence needed for the selected question with the available material.
Referenced methods
Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design; M04 §4.5 and §4.6.3; Limits of this conversion follow the user-defined scope and Chamgap design; M08 Table 8.2.a and M04 §4.6.3; Chamgap application
N25 · What are the 144 serious adverse events and 26 possibly related events?
Required materials and conditions
The distinction between original event counts/possible relatedness and participants, rates and causality
Conditions for verification
The relevant source material and analysis scope for The distinction between original event counts/possible relatedness and participants, rates and causality must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Supplementary
Application exceptions
Supplements gaps in harm data for the selected six-week maternal death or morbidity composite question. Original serious adverse events/Good safety are not extended to safety of every technique/patient, harm causality/rates or exclusion of long-term differences. No guidance on choosing, performing or determining suitability of surgery/devices/sutures is created.
Why this condition is needed
This item distinguishes The distinction between original event counts/possible relatedness and participants, rates and causality to connect the evidence needed for the selected question with the available material.
Referenced methods
M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretation boundary. M19 principles are referenced; no official causality tool was run
N26 · Is absence of an established consistent harm advantage the same as overall safety?
Required materials and conditions
The original safety summary and gaps in factor-specific, vulnerable-group and long-term harms
Conditions for verification
The relevant source material and analysis scope for The original safety summary and gaps in factor-specific, vulnerable-group and long-term harms must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Supplementary
Application exceptions
Supplements gaps in harm data for the selected six-week maternal death or morbidity composite question. Original serious adverse events/Good safety are not extended to safety of every technique/patient, harm causality/rates or exclusion of long-term differences. No guidance on choosing, performing or determining suitability of surgery/devices/sutures is created.
Why this condition is needed
This item distinguishes The original safety summary and gaps in factor-specific, vulnerable-group and long-term harms to connect the evidence needed for the selected question with the available material.
Referenced methods
M19 §19.1.2–19.2.4; Chamgap application; M19 §19.2.2–19.2.4 and M03 §3.2.3; Chamgap application; M19 §19.1.2–19.2.4 and M04 §4.6.3; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretation boundary. M19 principles are referenced; no official causality tool was run
N27 · Can the findings be extended to operating time, convenience or superiority in other populations?
Required materials and conditions
Technical convenience versus maternal clinical outcomes and exposure history
Conditions for verification
The relevant source material and analysis scope for Technical convenience versus maternal clinical outcomes and exposure history must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes Technical convenience versus maternal clinical outcomes and exposure history to connect the evidence needed for the selected question with the available material.
Referenced methods
Question clarification principles in M03 §3.1 and §3.2.1–3.2.4; Detailed separation rules are Chamgap design; M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4; Chamgap interpretation boundary
N28 · How much of the original summary, external papers and Chamgap links was actually read?
Required materials and conditions
The full stored summary, initial/follow-up PMIDs, Chamgap links and unread external material
Conditions for verification
The relevant source material and analysis scope for The full stored summary, initial/follow-up PMIDs, Chamgap links and unread external material must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes The full stored summary, initial/follow-up PMIDs, Chamgap links and unread external material to connect the evidence needed for the selected question with the available material.
Referenced methods
Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design; M04 §4.5 and §4.6.3; Limits of this conversion follow the user-defined scope and Chamgap design
N29 · How are KO/EN, the original verdict, dates, correction history/empty values and historical cross-checks preserved?
Required materials and conditions
Original D34, Good, assessment axes, 2026-08-26 and existing empty values
Conditions for verification
The relevant source material and analysis scope for Original D34, Good, assessment axes, 2026-08-26 and existing empty values must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes Original D34, Good, assessment axes, 2026-08-26 and existing empty values to connect the evidence needed for the selected question with the available material.
Referenced methods
Question clarification principles in M03 §3.1 and §3.2.1–3.2.4; Detailed separation rules are Chamgap design; M04 §4.5 and §4.6.3; Limits of this conversion follow the user-defined scope and Chamgap design
N30 · Are condition preservation, application, case production and review separate records?
Required materials and conditions
Production sequence and incomplete user review
Conditions for verification
The relevant source material and analysis scope for Production sequence and incomplete user review must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
This item distinguishes Production sequence and incomplete user review to connect the evidence needed for the selected question with the available material.
Referenced methods
Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design; M04 §4.5 and §4.6.3; Limits of this conversion follow the user-defined scope and Chamgap design
Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle
Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle
Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle
Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle
Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle
Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution
What the statuses mean
Met
A state used when required evidence is confirmed after user review. This production does not declare that review complete.
Partly verified
Some information in the stored summary is linked into the table. External comparison/content review is not complete.
Unverified
The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
Review incomplete
User review pending.
Not reported
Not reported within the stored material actually read; not extended to the entire primary paper.
Inaccessible
Means an actual access failure. Access not attempted here is not assigned this state.
Not applicable
Not used as a substitute for an evidence gap.
Conflicting data
Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
Insufficient evidence for the conditions
Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

Change history

2026-10-10 · Public page/material version 1.0

The public page and data were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · What are the selected question and original verdict?

Current findings
The question is “Reduced six-week maternal death or morbidity composite” and links to the complete existing verdict record. Original D34, Good and H/R1/I2/E0/B0/C0 are retained.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but The existing candidate history is preserved. No new subquestion or statement of absent/inherited scores is created. User review of the table remains pending.
Reason for missing information
The existing candidate history is preserved. No new subquestion or statement of absent/inherited scores is created.
Required materials and conditions
The distinction between the selected question and original D34 verdict/assessment axes
Materials to obtain first
Preserved copies of the original question/verdict and candidate history
Further research
A proposed later production record distinguishing the selected question from the existing verdict record. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for The distinction between the selected question and original D34 verdict/assessment axes must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes The distinction between the selected question and original D34 verdict/assessment axes to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Question clarification principles in M03 §3.1 and §3.2.1–3.2.4; Detailed separation rules are Chamgap design; M04 §4.5 and §4.6.3; Limits of this conversion follow the user-defined scope and Chamgap design

Related sources S01

N02 · Which events are included in the six-week maternal death or morbidity composite?

Current findings
The existing research explanation describes a prespecified primary composite of clinical events such as death, readmission, reoperation and transfusion. It is not transferred to a reduction in each component or mortality alone.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Complete component definitions, severity/adjudication/duplicate handling and component-specific events/denominators are unverified. User review of the table remains pending.
Reason for missing information
Complete component definitions, severity/adjudication/duplicate handling and component-specific events/denominators are unverified.
Required materials and conditions
The composite definition, including clinical events such as death, readmission, reoperation and transfusion
Materials to obtain first
Composite/component definitions, adjudication and outcome tables
Further research
Proposed later material reporting the composite and its components separately. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for The composite definition, including clinical events such as death, readmission, reoperation and transfusion must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes The composite definition, including clinical events such as death, readmission, reoperation and transfusion to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary

Related sources S01

N03 · What are the population, sites, countries and recruitment scope?

Current findings
Original CORONIS enrolled 15,935 women at 19 sites in seven countries. Actual ages, emergency/planned surgery, baseline risks and exclusions are not filled in to generalize to every caesarean population.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Eligibility/exclusions, surgical indications/baseline risk, site composition and recruitment periods are unverified. User review of the table remains pending.
Reason for missing information
Eligibility/exclusions, surgical indications/baseline risk, site composition and recruitment periods are unverified.
Required materials and conditions
The 15,935 women, 19 sites, seven countries and actual eligibility/baseline risk
Materials to obtain first
Original eligibility, baseline/site tables and recruitment material
Further research
Proposed material distinguishing the original population from other settings/populations. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for The 15,935 women, 19 sites, seven countries and actual eligibility/baseline risk must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes The 15,935 women, 19 sites, seven countries and actual eligibility/baseline risk to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design

Related sources S01

N04 · How were the five comparisons allocated in the fractional factorial design?

Current findings
The original was an open randomized nonregular fractional factorial design, with each site participating in three of five comparisons. It is not assumed that every woman participated in all five.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Site/participant factor allocation, possible combinations and comparison-specific analysis populations are unverified. User review of the table remains pending.
Reason for missing information
Site/participant factor allocation, possible combinations and comparison-specific analysis populations are unverified.
Required materials and conditions
The distinction between the 2×2×2×2×2 nonregular fractional factorial design and three pairs per site
Materials to obtain first
Fractional factorial allocation, site participation and comparison flow diagrams
Further research
Proposed fractional factorial reporting specifying comparison populations and sharing. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for The distinction between the 2×2×2×2×2 nonregular fractional factorial design and three pairs per site must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes The distinction between the 2×2×2×2×2 nonregular fractional factorial design and three pairs per site to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M08 §8.1–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application

Related sources S01

N05 · What was the original six-week result for blunt versus sharp abdominal entry?

Current findings
Original six-week blunt versus sharp abdominal entry RR (95% CI): 1.03 (0.91–1.17). The original direction and interval are preserved, without transferring the effect to another technique, component or period.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Event counts, denominators, models/adjustment and prespecified important differences for this comparison are unverified. User review of the table remains pending.
Reason for missing information
Event counts, denominators, models/adjustment and prespecified important differences for this comparison are unverified.
Required materials and conditions
Comparison direction, RR/95% CI and composite outcome for blunt versus sharp abdominal entry
Materials to obtain first
Original factor-comparison events/denominators, analysis tables and plans
Further research
Proposed later material separating this comparison’s composite/component outcomes and intervals. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for Comparison direction, RR/95% CI and composite outcome for blunt versus sharp abdominal entry must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes Comparison direction, RR/95% CI and composite outcome for blunt versus sharp abdominal entry to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

Related sources S01

N06 · What was the original six-week result for exteriorized versus intra-abdominal uterine repair?

Current findings
Original six-week exteriorized versus intra-abdominal uterine repair RR (95% CI): 0.96 (0.84–1.08). The original direction and interval are preserved, without transferring the effect to another technique, component or period.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Event counts, denominators, models/adjustment and prespecified important differences for this comparison are unverified. User review of the table remains pending.
Reason for missing information
Event counts, denominators, models/adjustment and prespecified important differences for this comparison are unverified.
Required materials and conditions
Comparison direction, RR/95% CI and composite outcome for exteriorized versus intra-abdominal uterine repair
Materials to obtain first
Original factor-comparison events/denominators, analysis tables and plans
Further research
Proposed later material separating this comparison’s composite/component outcomes and intervals. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for Comparison direction, RR/95% CI and composite outcome for exteriorized versus intra-abdominal uterine repair must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes Comparison direction, RR/95% CI and composite outcome for exteriorized versus intra-abdominal uterine repair to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

Related sources S01

N07 · What was the original six-week result for single- versus double-layer uterine closure?

Current findings
Original six-week single- versus double-layer uterine closure RR (95% CI): 0.96 (0.85–1.08). The original direction and interval are preserved, without transferring the effect to another technique, component or period.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Event counts, denominators, models/adjustment and prespecified important differences for this comparison are unverified. User review of the table remains pending.
Reason for missing information
Event counts, denominators, models/adjustment and prespecified important differences for this comparison are unverified.
Required materials and conditions
Comparison direction, RR/95% CI and composite outcome for single- versus double-layer uterine closure
Materials to obtain first
Original factor-comparison events/denominators, analysis tables and plans
Further research
Proposed later material separating this comparison’s composite/component outcomes and intervals. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for Comparison direction, RR/95% CI and composite outcome for single- versus double-layer uterine closure must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes Comparison direction, RR/95% CI and composite outcome for single- versus double-layer uterine closure to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

Related sources S01

N08 · What was the original six-week result for peritoneal closure versus nonclosure?

Current findings
Original six-week peritoneal closure versus nonclosure RR (95% CI): 1.06 (0.94–1.20). The original direction and interval are preserved, without transferring the effect to another technique, component or period.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Event counts, denominators, models/adjustment and prespecified important differences for this comparison are unverified. User review of the table remains pending.
Reason for missing information
Event counts, denominators, models/adjustment and prespecified important differences for this comparison are unverified.
Required materials and conditions
Comparison direction, RR/95% CI and composite outcome for peritoneal closure versus nonclosure
Materials to obtain first
Original factor-comparison events/denominators, analysis tables and plans
Further research
Proposed later material separating this comparison’s composite/component outcomes and intervals. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for Comparison direction, RR/95% CI and composite outcome for peritoneal closure versus nonclosure must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes Comparison direction, RR/95% CI and composite outcome for peritoneal closure versus nonclosure to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

Related sources S01

N09 · What was the original six-week result for chromic catgut versus polyglactin-910 sutures?

Current findings
Original six-week chromic catgut versus polyglactin-910 suture RR (95% CI): 0.90 (0.78–1.04). The original direction and interval are preserved, without transferring the effect to another technique, component or period.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Event counts, denominators, models/adjustment and prespecified important differences for this comparison are unverified. User review of the table remains pending.
Reason for missing information
Event counts, denominators, models/adjustment and prespecified important differences for this comparison are unverified.
Required materials and conditions
Comparison direction, RR/95% CI and composite outcome for chromic catgut versus polyglactin-910 sutures
Materials to obtain first
Original factor-comparison events/denominators, analysis tables and plans
Further research
Proposed later material separating this comparison’s composite/component outcomes and intervals. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for Comparison direction, RR/95% CI and composite outcome for chromic catgut versus polyglactin-910 sutures must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes Comparison direction, RR/95% CI and composite outcome for chromic catgut versus polyglactin-910 sutures to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

Related sources S01

N10 · Do nonsignificance and the original null verdict establish equivalence or exclude benefit?

Current findings
The original describes five null comparisons but records D34 because there is no benefit-exclusion boundary. CIs including 1 are not extended to perfect equivalence, exclusion of every small difference or an individual safety guarantee.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Prespecified minimum important effects/equivalence margins and the size of rare-outcome effects that can be excluded are unverified. User review of the table remains pending.
Reason for missing information
Prespecified minimum important effects/equivalence margins and the size of rare-outcome effects that can be excluded are unverified.
Required materials and conditions
Original D34/E0/C0 and the absence of a benefit-exclusion boundary
Materials to obtain first
Comparison-specific prespecified importance, effect-exclusion criteria and original intervals
Further research
Proposed material specifying uncertainty about rare or small differences. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for Original D34/E0/C0 and the absence of a benefit-exclusion boundary must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes Original D34/E0/C0 and the absence of a benefit-exclusion boundary to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M04 §4.6.3 and M15 §15.3.1–15.3.3; Status separation is Chamgap design; M15 §15.3.1–15.3.3; Chamgap application

Related sources S01

N11 · Can absolute events and absolute differences be established from RRs?

Current findings
The existing verdict rationale says absolute differences were not reverse-calculated from RRs because the abstract lacked absolute event counts. No new event counts, absolute differences, individual risks or hypothetical examples are created.
Verification status
Unverified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. Required information is currently unverified. Original event counts, control risks, comparison-specific assessment denominators and absolute intervals are unverified. User review of the table remains pending.
Reason for missing information
Original event counts, control risks, comparison-specific assessment denominators and absolute intervals are unverified.
Required materials and conditions
The distinction between absent absolute event counts in the original abstract and relative RRs
Materials to obtain first
Material providing original outcome-table events/denominators and absolute effects
Further research
Proposed later material reporting absolute and relative outcomes from their respective original sources. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for The distinction between absent absolute event counts in the original abstract and relative RRs must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes The distinction between absent absolute event counts in the original abstract and relative RRs to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

Related sources S01

N12 · Are the full 15,935 women and each factor’s denominator the same?

Current findings
The 15,935 women are the original total trial population. They are not used as an identical denominator for all five comparisons, as the observed population for every event/safety outcome, or as new total participants.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Actual denominators and missing/excluded observations by comparison, group, component and timepoint are unverified. User review of the table remains pending.
Reason for missing information
Actual denominators and missing/excluded observations by comparison, group, component and timepoint are unverified.
Required materials and conditions
Total randomized participants and factor-, component- and follow-up-specific denominators
Materials to obtain first
Factor-specific randomization, assessment, ITT and safety denominators/flow diagrams
Further research
Proposed reporting linking each outcome’s denominator to its factor/timepoint. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for Total randomized participants and factor-, component- and follow-up-specific denominators must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes Total randomized participants and factor-, component- and follow-up-specific denominators to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

Related sources S01

N13 · How are shared participants, factors, groups, events and interactions distinguished?

Current findings
The five factors and composite/component outcomes are overlapping conditions of the same CORONIS trial. Different comparisons are not counted as new independent trials, and absence of interaction is not certified.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Model factors/interactions, site effects, repeated-event handling and shared populations are unverified. User review of the table remains pending.
Reason for missing information
Model factors/interactions, site effects, repeated-event handling and shared populations are unverified.
Required materials and conditions
Fractional factorial overlap, repeated observations/interactions and independent comparisons
Materials to obtain first
Fractional factorial analysis models and interaction/site analysis plans
Further research
Proposed reporting separating shared structure from factor-specific results. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for Fractional factorial overlap, repeated observations/interactions and independent comparisons must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes Fractional factorial overlap, repeated observations/interactions and independent comparisons to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

Related sources S01

N14 · What is the scope of the original allocation concealment, open surgery and ITT statements?

Current findings
The existing research explanation cites a secure central telephone randomisation service, open surgery and ITT for B0. This is not inherited as a current review of allocation, blinding or missingness, or certification that every event adjudication was unbiased.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Sequence generation, site deviations, assessor blinding and ITT exclusions/missingness details are unverified. User review of the table remains pending.
Reason for missing information
Sequence generation, site deviations, assessor blinding and ITT exclusions/missingness details are unverified.
Required materials and conditions
Central telephone randomization, unmasked surgery, ITT and actual implementation
Materials to obtain first
Allocation/adjudication procedures, ITT flow and missing-data handling
Further research
Proposed reporting separating open surgery from event ascertainment/missingness. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for Central telephone randomization, unmasked surgery, ITT and actual implementation must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes Central telephone randomization, unmasked surgery, ITT and actual implementation to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 §8.1–8.2.3; Chamgap application; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application

Related sources S01

N15 · What differs in common care, sites and surgical conditions?

Current findings
The original five comparisons concern incision and closure techniques. Common/group-specific anaesthesia, prophylactic antibiotics, surgeon experience and other care are not assumed to have been identical.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Co-interventions/deviations, surgeons/sites, actual technique exposure and adherence are unverified. User review of the table remains pending.
Reason for missing information
Co-interventions/deviations, surgeons/sites, actual technique exposure and adherence are unverified.
Required materials and conditions
Factor contrasts, other surgical/anaesthetic/drug treatments and site conditions
Materials to obtain first
Actual treatment, co-intervention and deviation material by group/factor/site
Further research
Proposed later material distinguishing technique comparisons from other treatment contributions. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for Factor contrasts, other surgical/anaesthetic/drug treatments and site conditions must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes Factor contrasts, other surgical/anaesthetic/drug treatments and site conditions to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

Related sources S01

N16 · What is the six-week observation window and follow-up/missingness specification?

Current findings
The original primary endpoint is maternal death or morbidity through six weeks. Long-term maternal/subsequent-pregnancy outcomes are not merged into that six-week endpoint.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Visit windows, follow-up methods, missingness/attrition, event ascertainment and ITT missing-data handling are unverified. User review of the table remains pending.
Reason for missing information
Visit windows, follow-up methods, missingness/attrition, event ascertainment and ITT missing-data handling are unverified.
Required materials and conditions
The six-week maternal composite, observation timing/duration and the period after it ends
Materials to obtain first
Six-week visits/event ascertainment, flow diagrams and missingness/SAP material
Further research
Proposed reporting separating short-term endpoints from long-term follow-up. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for The six-week maternal composite, observation timing/duration and the period after it ends must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes The six-week maternal composite, observation timing/duration and the period after it ends to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design

Related sources S01

N17 · What are the hierarchy and multiplicity rules for five primary comparisons and other outcomes?

Current findings
The existing research explanation states agreement between ISRCTN31089967 and the six-week primary endpoint. It does not establish that all long-term, component or subgroup results were prespecified confirmatory primary outcomes.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Protocols/SAPs, multiplicity, interactions/subgroups and registration changes have not been read. User review of the table remains pending.
Reason for missing information
Protocols/SAPs, multiplicity, interactions/subgroups and registration changes have not been read.
Required materials and conditions
The original prespecified primary composite, five comparisons, plans and multiplicity
Materials to obtain first
Registration/protocol/SAP versions specifying outcome hierarchy and multiplicity
Further research
Proposed material presenting planned and actually reported outcomes separately. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for The original prespecified primary composite, five comparisons, plans and multiplicity must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes The original prespecified primary composite, five comparisons, plans and multiplicity to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design; M08 Table 8.2.a and M04 §4.6.3; Chamgap application

Related sources S01

N18 · Is the 2016 follow-up a new independent trial?

Current findings
The original evidence preserves the 2013 report and 2016 follow-up of the same trial together. The two PMIDs, timepoints and outcomes are not added as independent replications or new total participants.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Unique trial/participant and independent replication totals are not established and remain null. User review of the table remains pending.
Reason for missing information
Unique trial/participant and independent replication totals are not established and remain null.
Required materials and conditions
The 2013/2016 reports and the same CORONIS trial/population
Materials to obtain first
Original population linkage for initial/follow-up reports
Further research
Proposed later linkage distinguishing report counts from study families/follow-up participants. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for The 2013/2016 reports and the same CORONIS trial/population must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes The 2013/2016 reports and the same CORONIS trial/population to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

Related sources S01 S02

N19 · How are the three-year report, mean 3.8 years and 13,153 women (84%) preserved?

Current findings
The original counterview’s three-year report describes 13,153 women (84%) followed for a mean 3.8 years. Attrition counts/rates are not calculated from these values and the full 15,935 women, and original values are not corrected.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but The follow-up-eligible denominator, contact/selection/attrition and factor-specific analysis counts/missingness are unverified. User review of the table remains pending.
Reason for missing information
The follow-up-eligible denominator, contact/selection/attrition and factor-specific analysis counts/missingness are unverified.
Required materials and conditions
Report designation, actual mean follow-up and original follow-up counts/proportion
Materials to obtain first
Long-term follow-up flow, original denominators/timepoints and factor-specific missingness
Further research
Proposed long-term reporting specifying how original numbers relate to populations/timepoints. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for Report designation, actual mean follow-up and original follow-up counts/proportion must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes Report designation, actual mean follow-up and original follow-up counts/proportion to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design

Related sources S02

N20 · Are representative long-term outcomes the same as the six-week composite?

Current findings
Original representative long-term values: abdominal hernia 0.66 (0.39–1.11), infertility 0.91 (0.71–1.18), maternal death 0.78 (0.46–1.32), infertility 0.80 (0.61–1.06), and subsequent-pregnancy uterine rupture 3.05 (0.32–29.29). Each original factor contrast is retained, without transfer to the six-week composite effect.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Population, events, denominators, timepoints, prespecified plans and CI interpretation criteria for each long-term outcome are unverified. User review of the table remains pending.
Reason for missing information
Population, events, denominators, timepoints, prespecified plans and CI interpretation criteria for each long-term outcome are unverified.
Required materials and conditions
Abdominal hernia, infertility, maternal death and subsequent-pregnancy uterine rupture versus six-week outcomes
Materials to obtain first
Outcome tables linking each factor to long-term outcomes/denominators, follow-up and plans
Further research
Proposed later material reporting uncertainty separately for each long-term outcome. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for Abdominal hernia, infertility, maternal death and subsequent-pregnancy uterine rupture versus six-week outcomes must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes Abdominal hernia, infertility, maternal death and subsequent-pregnancy uterine rupture versus six-week outcomes to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design

Related sources S02

N21 · What does the original interval for rare uterine rupture not establish?

Current findings
Original uterine rupture RR 3.05 (0.32–29.29) concerns a long-term subsequent-pregnancy outcome. It is not newly judged as confirmation of six-week harm, zero risk, exclusion of all small differences or evidence for individual technique choice.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but The relevant subsequent-pregnancy denominator, events/missingness, original prespecified hierarchy and harm-exclusion boundary are unverified. User review of the table remains pending.
Reason for missing information
The relevant subsequent-pregnancy denominator, events/missingness, original prespecified hierarchy and harm-exclusion boundary are unverified.
Required materials and conditions
Catgut/polyglactin subsequent-pregnancy uterine rupture RR 3.05 (0.32–29.29)
Materials to obtain first
Original rare-event denominators/ascertainment, plans and intervals
Further research
Proposed material separately reporting rare harms and uncertainty in subsequent pregnancies. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for Catgut/polyglactin subsequent-pregnancy uterine rupture RR 3.05 (0.32–29.29) must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes Catgut/polyglactin subsequent-pregnancy uterine rupture RR 3.05 (0.32–29.29) to connect the evidence needed for the selected question with the available material.
Application exceptions
Supplements gaps in harm data for the selected six-week maternal death or morbidity composite question. Original serious adverse events/Good safety are not extended to safety of every technique/patient, harm causality/rates or exclusion of long-term differences. No guidance on choosing, performing or determining suitability of surgery/devices/sutures is created.
Referenced methods
M15 §15.3.1–15.3.3; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretation boundary. M19 principles are referenced; no official causality tool was run

Related sources S02

N22 · Is the case 2641 azithromycin citation replication of the surgical technique evidence?

Current findings
The existing context citation links a Chamgap article about a different drug intervention. It is not transferred into a direct CORONIS incision/closure result, independent replication or the same population.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but That article and primary paper have not been read here and are not used as direct technique comparison material. User review of the table remains pending.
Reason for missing information
That article and primary paper have not been read here and are not used as direct technique comparison material.
Required materials and conditions
A context link for a different infection-prevention drug versus direct technique comparisons
Materials to obtain first
Original citation context and user-provided material for the separate drug question
Further research
Proposed relationship records separating technique and infection-prevention drug questions. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for A context link for a different infection-prevention drug versus direct technique comparisons must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes A context link for a different infection-prevention drug versus direct technique comparisons to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

Related sources S03

N23 · Are public/nonprofit funding, COI and actual research roles the same?

Current findings
Original funding is from the UK MRC and WHO, public/nonprofit sources. It is not extended to absence of all product support, employee authors or COI, or to current independence certification.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Supply/manufacture, institution/author roles, analysis/writing contributions and complete COI disclosures have not been read. User review of the table remains pending.
Reason for missing information
Supply/manufacture, institution/author roles, analysis/writing contributions and complete COI disclosures have not been read.
Required materials and conditions
MRC/WHO funding, original I2 axis and product/author/control roles
Materials to obtain first
Original funding, product support, author roles and COI disclosures
Further research
Proposed reporting distinguishing funding type from research control/contributions. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for MRC/WHO funding, original I2 axis and product/author/control roles must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes MRC/WHO funding, original I2 axis and product/author/control roles to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

Related sources S01 S02

N24 · Does ISRCTN31089967 and historical agreement mean the registration was read here?

Current findings
Original ISRCTN31089967 and historical primary-endpoint agreement wording are preserved. The identifier or historical wording does not establish current access, registration-change checks or plan verification.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Registration, changes, protocols and SAPs have not been read, and access has not been attempted. User review of the table remains pending.
Reason for missing information
Registration, changes, protocols and SAPs have not been read, and access has not been attempted.
Required materials and conditions
The stored registration text versus actual reading of registration/plans
Materials to obtain first
User-provided copies of original registration/plans
Further research
Proposed material linking registration versions with actually reported outcomes. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for The stored registration text versus actual reading of registration/plans must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes The stored registration text versus actual reading of registration/plans to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design; M04 §4.5 and §4.6.3; Limits of this conversion follow the user-defined scope and Chamgap design; M08 Table 8.2.a and M04 §4.6.3; Chamgap application

Related sources S01 S02

N25 · What are the 144 serious adverse events and 26 possibly related events?

Current findings
The existing safety explanation describes 144 serious adverse events and 26 possibly intervention-related events. These are not calculated/changed into participant counts, incidence rates, factor-specific harm differences or established causality.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Safety participants/time, duplicate events, factor-specific groups, ascertainment/classification and severity details are unverified. User review of the table remains pending.
Reason for missing information
Safety participants/time, duplicate events, factor-specific groups, ascertainment/classification and severity details are unverified.
Required materials and conditions
The distinction between original event counts/possible relatedness and participants, rates and causality
Materials to obtain first
Safety outcome tables, collection/causality adjudication and exposure/denominators
Further research
Proposed reporting distinguishing events from people and factor-specific safety outcomes. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for The distinction between original event counts/possible relatedness and participants, rates and causality must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes The distinction between original event counts/possible relatedness and participants, rates and causality to connect the evidence needed for the selected question with the available material.
Application exceptions
Supplements gaps in harm data for the selected six-week maternal death or morbidity composite question. Original serious adverse events/Good safety are not extended to safety of every technique/patient, harm causality/rates or exclusion of long-term differences. No guidance on choosing, performing or determining suitability of surgery/devices/sutures is created.
Referenced methods
M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretation boundary. M19 principles are referenced; no official causality tool was run

Related sources S01 S02

N26 · Is absence of an established consistent harm advantage the same as overall safety?

Current findings
The original records Good safety and no established consistent harm advantage for a specific comparison. It is not extended to all techniques/patients, zero long-term risk, equal safety or individual suitability.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Factor-specific safety effects/intervals, vulnerable groups, missingness and long-term event comparisons are unverified. User review of the table remains pending.
Reason for missing information
Factor-specific safety effects/intervals, vulnerable groups, missingness and long-term event comparisons are unverified.
Required materials and conditions
The original safety summary and gaps in factor-specific, vulnerable-group and long-term harms
Materials to obtain first
Safety, missingness and ascertainment material by factor/population/period
Further research
Proposed material distinguishing short-/long-term harms and vulnerable populations. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for The original safety summary and gaps in factor-specific, vulnerable-group and long-term harms must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes The original safety summary and gaps in factor-specific, vulnerable-group and long-term harms to connect the evidence needed for the selected question with the available material.
Application exceptions
Supplements gaps in harm data for the selected six-week maternal death or morbidity composite question. Original serious adverse events/Good safety are not extended to safety of every technique/patient, harm causality/rates or exclusion of long-term differences. No guidance on choosing, performing or determining suitability of surgery/devices/sutures is created.
Referenced methods
M19 §19.1.2–19.2.4; Chamgap application; M19 §19.2.2–19.2.4 and M03 §3.2.3; Chamgap application; M19 §19.1.2–19.2.4 and M04 §4.6.3; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretation boundary. M19 principles are referenced; no official causality tool was run

Related sources S01 S02

N27 · Can the findings be extended to operating time, convenience or superiority in other populations?

Current findings
The existing advertising interpretation says operating time/technical convenience must not be extended to reduced maternal death or morbidity. No guidance on the user’s technique/suture choice, surgery or suitability is created.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but Direct comparisons of techniques/time or other populations/periods are separate from this question. User review of the table remains pending.
Reason for missing information
Direct comparisons of techniques/time or other populations/periods are separate from this question.
Required materials and conditions
Technical convenience versus maternal clinical outcomes and exposure history
Materials to obtain first
Comparison criteria when material for separate endpoints/populations is provided
Further research
Proposed material linking technical processes to patient clinical outcomes while distinguishing them. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for Technical convenience versus maternal clinical outcomes and exposure history must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes Technical convenience versus maternal clinical outcomes and exposure history to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Question clarification principles in M03 §3.1 and §3.2.1–3.2.4; Detailed separation rules are Chamgap design; M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4; Chamgap interpretation boundary

Related sources S01

N28 · How much of the original summary, external papers and Chamgap links was actually read?

Current findings
The full stored summary was used for production and marked as summary read. Only initial/follow-up PubMed URLs and the relative case 2641 URL are preserved; external summaries/articles, registration/plans and COI material have not been read.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but No link/click testing, external identity/full-text comparison or screen inspection was performed in the source preparation. User review of the table remains pending.
Reason for missing information
No link/click testing, external identity/full-text comparison or screen inspection was performed in the source preparation.
Required materials and conditions
The full stored summary, initial/follow-up PMIDs, Chamgap links and unread external material
Materials to obtain first
User-provided copies of papers, articles, registration and plans
Further research
Proposed records separating full-text/summary acquisition from actual reading scope for each material. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for The full stored summary, initial/follow-up PMIDs, Chamgap links and unread external material must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes The full stored summary, initial/follow-up PMIDs, Chamgap links and unread external material to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design; M04 §4.5 and §4.6.3; Limits of this conversion follow the user-defined scope and Chamgap design

Related sources S01 S02 S03

N29 · How are KO/EN, the original verdict, dates, correction history/empty values and historical cross-checks preserved?

Current findings
Korean/English articles, D34, Good, assessment axes, correction history, empty values, original reference date and historical cross-check/abstract wording are preserved. They are not inherited as a new verdict or completed correction/translation review.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but No current full-text comparison, new clinical update/correction or completed content review. User review of the table remains pending.
Reason for missing information
No current full-text comparison, new clinical update/correction or completed content review.
Required materials and conditions
Original D34, Good, assessment axes, 2026-08-26 and existing empty values
Materials to obtain first
Complete original copies/history or user-corrected material
Further research
Proposed records distinguishing original preservation from separate update/correction events. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for Original D34, Good, assessment axes, 2026-08-26 and existing empty values must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes Original D34, Good, assessment axes, 2026-08-26 and existing empty values to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Question clarification principles in M03 §3.1 and §3.2.1–3.2.4; Detailed separation rules are Chamgap design; M04 §4.5 and §4.6.3; Limits of this conversion follow the user-defined scope and Chamgap design

Related sources S01 S02 S03

N30 · Are condition preservation, application, case production and review separate records?

Current findings
Condition preservation/application, case production and completed review are separate records. Review of the existing content is incomplete and is distinguished from production.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
This is a display draft from the stored summary. The original contains some information, but User review is incomplete. The original preparation did not reread or review saved output, run checks/tests, or inspect links/screens. User review of the table remains pending.
Reason for missing information
User review is incomplete. The original preparation did not reread or review saved output, run checks/tests, or inspect links/screens.
Required materials and conditions
Production sequence and incomplete user review
Materials to obtain first
A separate production event when user comments/new material are provided
Further research
Proposed later records separately documenting production and user review/corrections. No new investigation, calculation or trial was performed here.
Remaining uncertainty
This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.
Conditions for verification
The relevant source material and analysis scope for Production sequence and incomplete user review must be available, with unverified points distinguished. This view links stored wording; user review remains pending.
Why this condition is needed
This item distinguishes Production sequence and incomplete user review to connect the evidence needed for the selected question with the available material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design; M04 §4.5 and §4.6.3; Limits of this conversion follow the user-defined scope and Chamgap design

Related sources S01 S02 S03