Metformin × birthweight above 4000 g: evidence checklist for pregnancy with overweight or obesity and no diabetes

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Comparative efficacyIs the original birthweight-above-4000-g claim and subclaim verdict separate from the parent z-score context?Required	The selected existing question is “Fewer births above 4000 g”; its original grade is D and its note records GRoW aRR 0.97, P=0.899. The parent verdict is D, 30 points, safety Caution, and synthesizes z-score and other results. R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Absent subclaim score, status and axes are not filled from parent values. No new verdict is made.	Distinction between selected wording, grade and note, and parent values	If additional material arrives, link the selected endpoint and parent context separately.
2	Partly verified	Full text not readStored summary read	N02 · Comparative efficacyIs the actual GRoW population distinguished from other pregnancy and diabetes contexts?Required	The GRoW bibliography specifies pregnant women with overweight or obesity; the parent record describes the context as pregnancy without diabetes. R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Trial-specific age, BMI, diabetes exclusions and pregnancy timing details remain unread. The verdict is not applied to treatment of gestational or type 2 diabetes.	Eligibility criteria for diabetes status, obesity, overweight, pregnancy timing and baseline status	Obtain original GRoW eligibility, baseline characteristics, recruitment conditions and denominators.
3	Partly verified	Full text not readStored summary read	N03 · Comparative efficacyAre GRoW intervention, placebo and research exposure directly preserved?Required	GRoW is recorded as a multicenter double-blind placebo-controlled randomized trial of metformin. R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. GRoW research dose, formulation, starting gestational week and actual exposure are absent from the summary. The EMPOWaR maximum of 2500 mg/day is not transferred.	Trial-specific original records of ingredient, formulation, dose, exposure and adherence	Link supplied original GRoW protocol and actual exposure material.
4	Partly verified	Full text not readStored summary read	N04 · Comparative efficacyIs the comparison of medication added to dietary and lifestyle advice preserved?Required	The GRoW bibliography records the comparison as metformin added to dietary and lifestyle advice. R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Whether advice content, contact, adherence and additional treatment were actually identical remains unread. No new dietary or pregnancy-management instructions are created.	Original material on common advice, placebo, added intervention and other care	Obtain original trial arm-specific common and differing care and actual exposure.
5	Partly verified	Full text not readStored summary read	N05 · Comparative efficacyAre the above-4000-g threshold, birth measurement and assessment unit distinguished?Required	The existing endpoint is “birthweight above 4000 g”; its English wording is birthweight above 4000 g. R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. It is not changed to at least 4000 g, birthweight z score, lower mean grams or another macrosomia definition. Measurement details remain unread.	Strictly-above definition, measurement timing, measurement method and analysis unit	Obtain the original endpoint definition, birthweight measurement, boundary-value handling and analysis unit.
6	Partly verified	Full text not readStored summary read	N06 · Comparative efficacyWhat are trial-specific primary/secondary hierarchies and plans for the birth endpoint?Required	EMPOWaR records standardized z score as primary. GRoW birthweight above 4000 g is preserved as a separate result. R01 R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. EMPOWaR’s primary hierarchy is not transferred to GRoW, and GRoW’s own hierarchy is not newly confirmed. Detailed prespecified plans remain unread.	Registration, protocol, SAP and multiplicity hierarchy for the selected endpoint	Link endpoint hierarchies and change histories separately from each trial’s registration, protocol and SAP.
7	Partly verified	Full text not readStored summary read	N07 · Comparative efficacyAre GRoW randomized and analyzed counts distinguished?Required	GRoW had 524 randomized and 514 analyzed. R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Arm-specific assignment or analysis counts and attrition rates absent from the original are not newly calculated. The 514 is not confirmed as a common denominator for every outcome.	Original arm-specific assignment, analysis, follow-up and missingness flow and denominators	Obtain original tables of arm-specific participant flow, exclusion, follow-up and outcome-specific analysis denominators.
8	Partly verified	Full text not readStored summary read	N08 · Comparative efficacyAre denominators for pregnant women, infants, birth events and repeated measurements the same?Required	The original material records randomized and analyzed counts as people, and birthweight above 4000 g as 40 versus 37 people. R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Detailed infant/pregnant-woman mapping, multiple-birth handling and recurrent events are absent from the summary and are not newly determined. Related sheets and participants are not summed.	Analysis units for people, pregnancies, infants and birth events, with handling of overlap	Obtain original analysis units, pregnancy/birth mapping, exclusions and denominators.
9	Partly verified	Full text not readStored summary read	N09 · Comparative efficacyAre the original 40 (16%) versus 37 (14%) values and arm order maintained?Required	The GRoW evidence list records 40 (16%) versus 37 (14%); the original text also preserves 16% versus 14%. R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Denominators are not reverse-calculated from percentages, and events are not increased. Original-summary arm-specific analysis denominators are not explicit.	Original arm-specific events, proportions, denominators and outcome tables	Link original table arm labels, events, denominators and proportions exactly as recorded.
10	Partly verified	Full text not readStored summary read	N10 · Comparative efficacyAre adjusted RR, CI and P preserved separately from original proportions?Required	aRR 0.97 (95% CI 0.65 to 1.47), P=0.899 is recorded as originally given. R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No crude RR, risk difference or NNT is calculated from original proportions, and reproduction of the adjusted value is not claimed. Adjustment variables and model remain unread.	Original material on adjusted effect, model, variables, interval and test	Obtain adjustment plans, variables, arm-specific denominators and original between-arm effect tables.
11	Partly verified	Full text not readStored summary read	N11 · Comparative efficacyHas a null result been kept separate from confirmed exclusion of meaningful reduction?Required	The original text records no demonstrated birthweight benefit but says meaningful benefit cannot be declared excluded because a validated prespecified clinical threshold is absent. R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The aRR CI and P are not converted into certification of zero effect, equivalence or exclusion of meaningful reduction.	A validated prespecified clinical threshold and effect interval	Obtain importance criteria, a prespecified validated threshold and plans suited to the population and endpoint.
12	Partly verified	Full text not readStored summary read	N12 · Comparative efficacyWere GRoW allocation and masking details kept separate from EMPOWaR?Required	GRoW’s design is a multicenter double-blind placebo-controlled randomized trial. EMPOWaR has separate allocation and masking quotations. R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. EMPOWaR web-based block randomization and study-personnel masking wording are not transferred as actual GRoW details.	Trial-specific allocation concealment, masking and outcome-measurement procedures	Obtain allocation, concealment, measurement and analysis procedures from the original GRoW methods.
13	Partly verified	Full text not readStored summary read	N13 · Comparative efficacyAre GRoW analysis population, missingness and follow-up methods directly supplied?Required	Only the summary of 524 randomized and 514 analyzed is preserved for GRoW. Explicit modified ITT and 97% belong to the EMPOWaR context. R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The EMPOWaR modified-ITT definition is not transferred to GRoW. No new missing-data handling or attrition rate is inferred.	Original material on ITT status, analysis exclusions, missingness reasons and sensitivity analyses	Obtain GRoW analysis-population definitions, arm exclusions, missing-data handling and sensitivity material.
14	Partly verified	Full text not readStored summary read	N14 · Comparative efficacyAre actual exposure, gastrointestinal symptoms and adherence linked to the birth analysis?Required	The parent record describes gastrointestinal adverse effects and lower adherence. R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. GRoW adherence counts or figures and symptom-specific exposure/outcome mapping cannot be verified from the summary. No post hoc adherence effect is newly calculated.	Trial-specific records of actual exposure, adherence, discontinuation and outcomes	Obtain actual GRoW exposure, discontinuation and adherence material and the prespecified effect of interest.
15	Partly verified	Full text not readStored summary read	N15 · Comparative efficacyAre birthweight above 4000 g, mean grams and z score the same endpoint?Required	EMPOWaR means of 3462 g versus 3463 g and its adjusted z-score difference of −0.029 are from a different trial and measures. MOP z scores are also preserved separately. R01 R02 R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Other trial measures are not filled as direct GRoW birthweight-above-4000-g values. A lower mean is not converted into fewer events.	Separate original definitions, denominators, timepoints and effects for each measure	If trial- and measure-specific results are supplied, link original endpoints and denominators separately.
16	Partly verified	Full text not readStored summary read	N16 · Comparative efficacyAre the EMPOWaR primary z-score result and analysis denominators maintained as context?Required	EMPOWaR randomized 449 (226/223) and had 434 in modified ITT; its adjusted z-score difference was −0.029 (95% CI −0.217 to 0.158), P=0.7597. R01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. These denominators and CI are not copied as birthweight-above-4000-g results. The relevant EMPOWaR event count and effect are absent from this stored summary.	Endpoint, denominator and plan boundaries of another trial	If EMPOWaR material for the selected event endpoint is supplied, link it with direct definitions and denominators.
17	Partly verified	Full text not readStored summary read	N17 · Comparative efficacyIs the MOP z-score report and registration link kept separate from direct evidence for the selected event?Required	MOP z scores of 0.05 versus 0.17, P=0.66 and “400 analyzed” are preserved. The citation URL is the NCT01273584 registration page. R02	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. MOP birthweight-above-4000-g events, effects and arm denominators are not supplied. The registration URL is not labeled as the paper’s full text.	Distinction between trial-specific bibliographies, material types, endpoints and effects	Obtain registration and the paper separately to link the selected event endpoint, plans and denominators.
18	Partly verified	Full text not readStored summary read	N18 · Comparative efficacyAre original repeated-null and independence wording distinguished from certification in this work?Required	The parent text records null birthweight results in three trials; GRoW’s original evidence-role wording is independent repeated null evidence. R01 R02 R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The three trials with different endpoints are not all counted as direct birthweight-above-4000-g trials. Original axes RX and I1 are not used as new independence certification.	Links between ingredient, pregnancy without diabetes, trial identity and study families	Link only direct trial-to-endpoint relationships and pass additional material to content review.
19	Partly verified	Full text not readStored summary read	N19 · Comparative efficacyDo the two related sheets share the same reports, trials and cohorts?Required	The z-score and above-4000-g sheets share the entire stored parent-verdict 2948 summary and three reports. R01 R02 R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Reports, participants, trials and repeated measurements are not summed as new independent material because there are two sheets. Unique trials and total participants remain unrecorded.	Explicit links between stored summary, bibliographies, trials and participants	Link additional reports to existing identifiers and preserve same-population relationships.
20	Partly verified	Full text not readStored summary read	N20 · Comparative efficacyHas the birth event been kept separate from later obesity and other clinical pregnancy outcomes?Required	The original text records birthweight as a surrogate for later obesity risk. The fatal composite is a separate harm outcome. R01 R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Birthweight-above-4000-g results are not converted into efficacy or null conclusions for later obesity, cesarean delivery, delivery complications or all pregnancy outcomes.	Direct distinction between birth measures, long-term clinical outcomes and other pregnancy outcomes	Each clinical outcome requires separate direct measurement, follow-up, denominators and effects.
21	Partly verified	Full text not readStored summary read	N21 · Comparative efficacyHas the verdict’s scope been kept separate from other diabetes treatment and pregnancy management?Required	The original text explicitly states that the verdict does not apply to treatment of gestational or type 2 diabetes and that mechanism explanations do not substitute for birthweight efficacy. R01 R02 R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No medication selection, use, dosing, stopping or replacement instructions or pregnancy-management methods are produced.	Direct evidence and boundaries for disease and indication contexts	Link evidence for a new indication to its separate population, comparator and endpoint.
22	Partly verified	Full text not readStored summary read	N22 · Comparative efficacyAre GRoW public funding and gaps in the four company roles distinguished?Required	GRoW funding names the Australian National Health and Medical Research Council; the citation records publicly funded independent replication. R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Manufacturer cash support, drug/placebo supply, employee authors and outside analysis-role details are not all filled as absent from this summary.	Separate records for cash support, product provision, affiliated authors and outside analysis providers	Obtain original GRoW funding, product supply, affiliations, analysis and writing roles separately.
23	Partly verified	Full text not readStored summary read	N23 · Comparative efficacyWere EMPOWaR Merck supply and role declarations kept separate from GRoW funding?Required	EMPOWaR MRC·NIHR support, Edinburgh/NHS co-sponsorship, free Merck drug/placebo supply and the no-role declaration are preserved as originally recorded. R01 R02 R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. They are not transferred as GRoW or MOP support, supply or analysis declarations. MOP funding retains the ambiguous original wording.	Trial-specific relationships of public support, sponsorship, products and company roles	Link original conflict-of-interest material for the three trials separately.
24	Partly verified	Full text not readStored summary read	N24 · Supplementary harm evidenceAre person, event and exposure denominators available for gastrointestinal harm, discontinuation and adherence?Required	Gastrointestinal adverse effects and lower adherence are recorded in the original safety account. R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. GRoW occurrence counts, rates, event relatedness, discontinuation counts and denominators separately remain unread. They are not filled as no adverse effects or safety.	Original trial- and arm-specific harm definition, collection, denominator, discontinuation and exposure tables	Obtain original GRoW safety tables and exposure, discontinuation and adherence material.
25	Partly verified	Full text not readStored summary read	N25 · Supplementary harm evidenceHas the EMPOWaR fatal composite’s composition and figures been kept separate from GRoW harm?Required	The EMPOWaR miscarriage, pregnancy termination, stillbirth and neonatal-death composite was 7 with metformin versus 2 with placebo, OR 3.60 (95% CI 0.74 to 17.50), P=0.11. R01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. These figures are not copied as matching GRoW event counts or effects. Component-specific and pregnant-woman/infant denominators remain unread.	Distinction between trials, arms, component events, follow-up and denominators	Link each trial’s component event definitions, original arm event tables and denominators.
26	Partly verified	Full text not readStored summary read	N26 · Supplementary harm evidenceAre nonsignificance and wide CIs for rare harm distinguished from confirmed safety?Required	The original text distinguishes confirmed harm from an uncertain signal because of the wide EMPOWaR CI and P=0.11. R01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The record is not converted into no risk, absence of all harm or confirmed harm. No new harm figure, CI or rate is produced.	Material directly addressing effects, precision, exposure and rare harm	Adequate arm-specific follow-up, component events, original effects and rare-harm material are needed.
27	Unverified	Full text not readStored summary read	N27 · Supplementary harm evidenceAre gaps for maternal, infant and long-term harm and replication material maintained?Required	The current preserved account covers pregnancy and birth-time outcomes and some harm summaries. R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new search was made for long-term GRoW maternal or infant follow-up or independent harm-replication material. Long-term safety is not confirmed.	Direct trial-specific maternal, fetal and neonatal material on long-term exposure and follow-up	Link population-specific direct harm, long-term follow-up and report relationships to original trials.
28	Partly verified	Full text not readStored summary read	N28 · Comparative efficacyAre original URLs, registration identifiers and actual reading status shown individually?Required	GRoW preserves its PubMed bibliography URL and ACTRN12612001277831 identifier. MOP connects its actual original registration URL to a separate registration entry. R01 R02 R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new URL is constructed from an identifier, and link existence alone does not upgrade a record to completed reading. All external material remains unread.	Individual material entries for summary, abstract, full text, registration, protocol and SAP	Link user-obtained original material with its individual material type and access status.
29	Partly verified	Full text not readStored summary read	N29 · Comparative efficacyAre reference date, original languages, corrections, empty values and parent history preserved?Required	The reference date 2026-08-26, empty correction array and empty deliberation string, Korean/English text, parent D30 with safety Caution, and original axes are preserved. R01 R02 R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. This production date is not changed into a clinical-verification date, and past cross-checks are not marked as passing this work’s content review.	Separate preservation of the entire stored summary, selected verdict record and parent values	Reflect new material and decisions as separate change events while preserving the entire original.
30	Partly verified	Full text not readStored summary read	N30 · Comparative efficacyIs the incomplete content-review marker distinguished from actual production and independence status?Supplementary	Existing review-pending, production-eligibility and boundary-review-needed values are preserved as history. The original content review is incomplete; the original model, content and boundary active-pending and completion markers are false. R01 R02 R03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. There is no new verdict, split or independence certification; additional new units remain 0 and the final independent count unrecorded.	Separate records of original candidate history, production status and review status	Reflect only user-provided decisions and materials as separate events.

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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: Pregnancy with overweight or obesity and no diabetes; trial-specific eligibility and baseline details remain unread
Ingredient, formulation and route: Metformin research intervention in the relevant trials; no instructions for selecting, using, taking or replacing medication
Dose: Only historical EMPOWaR research conditions are preserved: up to 2500 mg/day from 12–16 weeks of pregnancy until delivery; not transferred to MOP or GRoW
Comparator: Placebo in each trial; the GRoW comparison context of addition to dietary and lifestyle advice is preserved
Measured outcome: Selected reduction in births above 4000 g; direct GRoW results are distinct from z-score results in other trials
Duration: Outcome at birth; GRoW exposure details remain unverified
Questions outside this scope: Transfer to treatment of gestational or type 2 diabetes; Copying different results between z-score, mean-gram and birthweight-above-4000-g endpoints; Confirmation of effects on long-term obesity or other clinical events; Medication selection, use, replacement, dosing or pregnancy-management instructions

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.

R01 · Chiswick C, Reynolds RM, Denison F, et al. Effect of metformin on maternal and fetal outcomes in obese pregnant women (EMPOWaR). Lancet Diabetes Endocrinol. 2015;3:778-786. PMID: 26165398.

PubMed

Material type: Trial report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: 0.2464 versus 0.2680; adjusted difference −0.029 (95% CI −0.217 to 0.158), P=0.7597; raw means 3462 g versus 3463 g
Record level: Stored evidence summary; not a result of directly reading external papers or registration
Study overlap and independent replication: EMPOWaR: report shared by two subclaim sheets; MOP: paper bibliography and registration link shared by two subclaim sheets; GRoW: report shared by two subclaim sheets. Report connections do not certify a unique-trial count; existing trials, reports, related sheets and participants are not newly summed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
local_summary	Original source link preserved	Summary read	Summary read	Stored parent-verdict summary
abstract	Original source link preserved	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
fulltext	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
registration	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
protocol_sap	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review

R02 · Syngelaki A, Nicolaides KH, Balani J, et al. Metformin versus Placebo in Obese Pregnant Women without Diabetes Mellitus. N Engl J Med. 2016. NCT01273584.

Official source

Material type: Paper bibliography and registration link
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: 0.05 versus 0.17, P=0.66
Record level: Stored evidence summary; not a result of directly reading external papers or registration
Study overlap and independent replication: EMPOWaR: report shared by two subclaim sheets; MOP: paper bibliography and registration link shared by two subclaim sheets; GRoW: report shared by two subclaim sheets. Report connections do not certify a unique-trial count; existing trials, reports, related sheets and participants are not newly summed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
local_summary	Original source link preserved	Summary read	Summary read	Stored parent-verdict summary
abstract	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
fulltext	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
registration	Original source link preserved	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
protocol_sap	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review

R03 · Dodd JM, Louise J, Deussen AR, et al. Effect of metformin in addition to dietary and lifestyle advice for pregnant women who are overweight or obese: the GRoW trial. Lancet Diabetes Endocrinol. 2019;7:15-24. PMID: 30528218.

PubMed

Material type: Trial report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: 40 (16%) versus 37 (14%), aRR 0.97 (95% CI 0.65 to 1.47), P=0.899
Record level: Stored evidence summary; not a result of directly reading external papers or registration
Study overlap and independent replication: EMPOWaR: report shared by two subclaim sheets; MOP: paper bibliography and registration link shared by two subclaim sheets; GRoW: report shared by two subclaim sheets. Report connections do not certify a unique-trial count; existing trials, reports, related sheets and participants are not newly summed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
local_summary	Original source link preserved	Summary read	Summary read	Stored parent-verdict summary
abstract	Original source link preserved	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
fulltext	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
registration	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
protocol_sap	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review

Report counts versus independent study counts

EMPOWaR: report shared by two subclaim sheets; MOP: paper bibliography and registration link shared by two subclaim sheets; GRoW: report shared by two subclaim sheets. Report connections do not certify a unique-trial count; existing trials, reports, related sheets and participants are not newly summed.

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 · Is the original birthweight-above-4000-g claim and subclaim verdict separate from the parent z-score context?

Required materials and conditions: Distinction between selected wording, grade and note, and parent values
Conditions for verification: Distinction between selected wording, grade and note, and parent values
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N02 · Is the actual GRoW population distinguished from other pregnancy and diabetes contexts?

Required materials and conditions: Eligibility criteria for diabetes status, obesity, overweight, pregnancy timing and baseline status
Conditions for verification: Eligibility criteria for diabetes status, obesity, overweight, pregnancy timing and baseline status
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N03 · Are GRoW intervention, placebo and research exposure directly preserved?

Required materials and conditions: Trial-specific original records of ingredient, formulation, dose, exposure and adherence
Conditions for verification: Trial-specific original records of ingredient, formulation, dose, exposure and adherence
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N04 · Is the comparison of medication added to dietary and lifestyle advice preserved?

Required materials and conditions: Original material on common advice, placebo, added intervention and other care
Conditions for verification: Original material on common advice, placebo, added intervention and other care
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N05 · Are the above-4000-g threshold, birth measurement and assessment unit distinguished?

Required materials and conditions: Strictly-above definition, measurement timing, measurement method and analysis unit
Conditions for verification: Strictly-above definition, measurement timing, measurement method and analysis unit
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N06 · What are trial-specific primary/secondary hierarchies and plans for the birth endpoint?

Required materials and conditions: Registration, protocol, SAP and multiplicity hierarchy for the selected endpoint
Conditions for verification: Registration, protocol, SAP and multiplicity hierarchy for the selected endpoint
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N07 · Are GRoW randomized and analyzed counts distinguished?

Required materials and conditions: Original arm-specific assignment, analysis, follow-up and missingness flow and denominators
Conditions for verification: Original arm-specific assignment, analysis, follow-up and missingness flow and denominators
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N08 · Are denominators for pregnant women, infants, birth events and repeated measurements the same?

Required materials and conditions: Analysis units for people, pregnancies, infants and birth events, with handling of overlap
Conditions for verification: Analysis units for people, pregnancies, infants and birth events, with handling of overlap
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N09 · Are the original 40 (16%) versus 37 (14%) values and arm order maintained?

Required materials and conditions: Original arm-specific events, proportions, denominators and outcome tables
Conditions for verification: Original arm-specific events, proportions, denominators and outcome tables
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N10 · Are adjusted RR, CI and P preserved separately from original proportions?

Required materials and conditions: Original material on adjusted effect, model, variables, interval and test
Conditions for verification: Original material on adjusted effect, model, variables, interval and test
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N11 · Has a null result been kept separate from confirmed exclusion of meaningful reduction?

Required materials and conditions: A validated prespecified clinical threshold and effect interval
Conditions for verification: A validated prespecified clinical threshold and effect interval
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N12 · Were GRoW allocation and masking details kept separate from EMPOWaR?

Required materials and conditions: Trial-specific allocation concealment, masking and outcome-measurement procedures
Conditions for verification: Trial-specific allocation concealment, masking and outcome-measurement procedures
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N13 · Are GRoW analysis population, missingness and follow-up methods directly supplied?

Required materials and conditions: Original material on ITT status, analysis exclusions, missingness reasons and sensitivity analyses
Conditions for verification: Original material on ITT status, analysis exclusions, missingness reasons and sensitivity analyses
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N14 · Are actual exposure, gastrointestinal symptoms and adherence linked to the birth analysis?

Required materials and conditions: Trial-specific records of actual exposure, adherence, discontinuation and outcomes
Conditions for verification: Trial-specific records of actual exposure, adherence, discontinuation and outcomes
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N15 · Are birthweight above 4000 g, mean grams and z score the same endpoint?

Required materials and conditions: Separate original definitions, denominators, timepoints and effects for each measure
Conditions for verification: Separate original definitions, denominators, timepoints and effects for each measure
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N16 · Are the EMPOWaR primary z-score result and analysis denominators maintained as context?

Required materials and conditions: Endpoint, denominator and plan boundaries of another trial
Conditions for verification: Endpoint, denominator and plan boundaries of another trial
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N17 · Is the MOP z-score report and registration link kept separate from direct evidence for the selected event?

Required materials and conditions: Distinction between trial-specific bibliographies, material types, endpoints and effects
Conditions for verification: Distinction between trial-specific bibliographies, material types, endpoints and effects
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N18 · Are original repeated-null and independence wording distinguished from certification in this work?

Required materials and conditions: Links between ingredient, pregnancy without diabetes, trial identity and study families
Conditions for verification: Links between ingredient, pregnancy without diabetes, trial identity and study families
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N19 · Do the two related sheets share the same reports, trials and cohorts?

Required materials and conditions: Explicit links between stored summary, bibliographies, trials and participants
Conditions for verification: Explicit links between stored summary, bibliographies, trials and participants
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N20 · Has the birth event been kept separate from later obesity and other clinical pregnancy outcomes?

Required materials and conditions: Direct distinction between birth measures, long-term clinical outcomes and other pregnancy outcomes
Conditions for verification: Direct distinction between birth measures, long-term clinical outcomes and other pregnancy outcomes
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N21 · Has the verdict’s scope been kept separate from other diabetes treatment and pregnancy management?

Required materials and conditions: Direct evidence and boundaries for disease and indication contexts
Conditions for verification: Direct evidence and boundaries for disease and indication contexts
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N22 · Are GRoW public funding and gaps in the four company roles distinguished?

Required materials and conditions: Separate records for cash support, product provision, affiliated authors and outside analysis providers
Conditions for verification: Separate records for cash support, product provision, affiliated authors and outside analysis providers
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N23 · Were EMPOWaR Merck supply and role declarations kept separate from GRoW funding?

Required materials and conditions: Trial-specific relationships of public support, sponsorship, products and company roles
Conditions for verification: Trial-specific relationships of public support, sponsorship, products and company roles
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N24 · Are person, event and exposure denominators available for gastrointestinal harm, discontinuation and adherence?

Required materials and conditions: Original trial- and arm-specific harm definition, collection, denominator, discontinuation and exposure tables
Conditions for verification: Original trial- and arm-specific harm definition, collection, denominator, discontinuation and exposure tables
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N25 · Has the EMPOWaR fatal composite’s composition and figures been kept separate from GRoW harm?

Required materials and conditions: Distinction between trials, arms, component events, follow-up and denominators
Conditions for verification: Distinction between trials, arms, component events, follow-up and denominators
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N26 · Are nonsignificance and wide CIs for rare harm distinguished from confirmed safety?

Required materials and conditions: Material directly addressing effects, precision, exposure and rare harm
Conditions for verification: Material directly addressing effects, precision, exposure and rare harm
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N27 · Are gaps for maternal, infant and long-term harm and replication material maintained?

Required materials and conditions: Direct trial-specific maternal, fetal and neonatal material on long-term exposure and follow-up
Conditions for verification: Direct trial-specific maternal, fetal and neonatal material on long-term exposure and follow-up
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N28 · Are original URLs, registration identifiers and actual reading status shown individually?

Required materials and conditions: Individual material entries for summary, abstract, full text, registration, protocol and SAP
Conditions for verification: Individual material entries for summary, abstract, full text, registration, protocol and SAP
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N29 · Are reference date, original languages, corrections, empty values and parent history preserved?

Required materials and conditions: Separate preservation of the entire stored summary, selected verdict record and parent values
Conditions for verification: Separate preservation of the entire stored summary, selected verdict record and parent values
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

N30 · Is the incomplete content-review marker distinguished from actual production and independence status?

Required materials and conditions: Separate records of original candidate history, production status and review status
Conditions for verification: Separate records of original candidate history, production status and review status
Requirement and applicability: Supplementary
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Fewer births above 4000 g

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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

What the statuses mean

Partly verified: Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.
Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete: Review of existing content incomplete
Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation
Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible: Not applied during this preparation because actual access was not tested
Not applicable: Use with a reason for non-applicability based on an explicit question boundary
Conflicting data: Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials

Change history

2026-10-11 · 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 · Is the original birthweight-above-4000-g claim and subclaim verdict separate from the parent z-score context?

Current findings: The selected existing question is “Fewer births above 4000 g”; its original grade is D and its note records GRoW aRR 0.97, P=0.899. The parent verdict is D, 30 points, safety Caution, and synthesizes z-score and other results.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Absent subclaim score, status and axes are not filled from parent values. No new verdict is made.
Reason for missing information: Absent subclaim score, status and axes are not filled from parent values. No new verdict is made.
Required materials and conditions: Distinction between selected wording, grade and note, and parent values
Materials to obtain first: Absent subclaim score, status and axes are not filled from parent values. No new verdict is made.
Further research: If additional material arrives, link the selected endpoint and parent context separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Distinction between selected wording, grade and note, and parent values
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R03

N02 · Is the actual GRoW population distinguished from other pregnancy and diabetes contexts?

Current findings: The GRoW bibliography specifies pregnant women with overweight or obesity; the parent record describes the context as pregnancy without diabetes.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Trial-specific age, BMI, diabetes exclusions and pregnancy timing details remain unread. The verdict is not applied to treatment of gestational or type 2 diabetes.
Reason for missing information: Trial-specific age, BMI, diabetes exclusions and pregnancy timing details remain unread. The verdict is not applied to treatment of gestational or type 2 diabetes.
Required materials and conditions: Eligibility criteria for diabetes status, obesity, overweight, pregnancy timing and baseline status
Materials to obtain first: Trial-specific age, BMI, diabetes exclusions and pregnancy timing details remain unread. The verdict is not applied to treatment of gestational or type 2 diabetes.
Further research: Obtain original GRoW eligibility, baseline characteristics, recruitment conditions and denominators.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Eligibility criteria for diabetes status, obesity, overweight, pregnancy timing and baseline status
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R03

N03 · Are GRoW intervention, placebo and research exposure directly preserved?

Current findings: GRoW is recorded as a multicenter double-blind placebo-controlled randomized trial of metformin.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. GRoW research dose, formulation, starting gestational week and actual exposure are absent from the summary. The EMPOWaR maximum of 2500 mg/day is not transferred.
Reason for missing information: GRoW research dose, formulation, starting gestational week and actual exposure are absent from the summary. The EMPOWaR maximum of 2500 mg/day is not transferred.
Required materials and conditions: Trial-specific original records of ingredient, formulation, dose, exposure and adherence
Materials to obtain first: GRoW research dose, formulation, starting gestational week and actual exposure are absent from the summary. The EMPOWaR maximum of 2500 mg/day is not transferred.
Further research: Link supplied original GRoW protocol and actual exposure material.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Trial-specific original records of ingredient, formulation, dose, exposure and adherence
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R03

N04 · Is the comparison of medication added to dietary and lifestyle advice preserved?

Current findings: The GRoW bibliography records the comparison as metformin added to dietary and lifestyle advice.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Whether advice content, contact, adherence and additional treatment were actually identical remains unread. No new dietary or pregnancy-management instructions are created.
Reason for missing information: Whether advice content, contact, adherence and additional treatment were actually identical remains unread. No new dietary or pregnancy-management instructions are created.
Required materials and conditions: Original material on common advice, placebo, added intervention and other care
Materials to obtain first: Whether advice content, contact, adherence and additional treatment were actually identical remains unread. No new dietary or pregnancy-management instructions are created.
Further research: Obtain original trial arm-specific common and differing care and actual exposure.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original material on common advice, placebo, added intervention and other care
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R03

N05 · Are the above-4000-g threshold, birth measurement and assessment unit distinguished?

Current findings: The existing endpoint is “birthweight above 4000 g”; its English wording is birthweight above 4000 g.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. It is not changed to at least 4000 g, birthweight z score, lower mean grams or another macrosomia definition. Measurement details remain unread.
Reason for missing information: It is not changed to at least 4000 g, birthweight z score, lower mean grams or another macrosomia definition. Measurement details remain unread.
Required materials and conditions: Strictly-above definition, measurement timing, measurement method and analysis unit
Materials to obtain first: It is not changed to at least 4000 g, birthweight z score, lower mean grams or another macrosomia definition. Measurement details remain unread.
Further research: Obtain the original endpoint definition, birthweight measurement, boundary-value handling and analysis unit.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Strictly-above definition, measurement timing, measurement method and analysis unit
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R03

N06 · What are trial-specific primary/secondary hierarchies and plans for the birth endpoint?

Current findings: EMPOWaR records standardized z score as primary. GRoW birthweight above 4000 g is preserved as a separate result.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. EMPOWaR’s primary hierarchy is not transferred to GRoW, and GRoW’s own hierarchy is not newly confirmed. Detailed prespecified plans remain unread.
Reason for missing information: EMPOWaR’s primary hierarchy is not transferred to GRoW, and GRoW’s own hierarchy is not newly confirmed. Detailed prespecified plans remain unread.
Required materials and conditions: Registration, protocol, SAP and multiplicity hierarchy for the selected endpoint
Materials to obtain first: EMPOWaR’s primary hierarchy is not transferred to GRoW, and GRoW’s own hierarchy is not newly confirmed. Detailed prespecified plans remain unread.
Further research: Link endpoint hierarchies and change histories separately from each trial’s registration, protocol and SAP.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Registration, protocol, SAP and multiplicity hierarchy for the selected endpoint
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R01 R03

N07 · Are GRoW randomized and analyzed counts distinguished?

Current findings: GRoW had 524 randomized and 514 analyzed.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Arm-specific assignment or analysis counts and attrition rates absent from the original are not newly calculated. The 514 is not confirmed as a common denominator for every outcome.
Reason for missing information: Arm-specific assignment or analysis counts and attrition rates absent from the original are not newly calculated. The 514 is not confirmed as a common denominator for every outcome.
Required materials and conditions: Original arm-specific assignment, analysis, follow-up and missingness flow and denominators
Materials to obtain first: Arm-specific assignment or analysis counts and attrition rates absent from the original are not newly calculated. The 514 is not confirmed as a common denominator for every outcome.
Further research: Obtain original tables of arm-specific participant flow, exclusion, follow-up and outcome-specific analysis denominators.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original arm-specific assignment, analysis, follow-up and missingness flow and denominators
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R03

N08 · Are denominators for pregnant women, infants, birth events and repeated measurements the same?

Current findings: The original material records randomized and analyzed counts as people, and birthweight above 4000 g as 40 versus 37 people.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Detailed infant/pregnant-woman mapping, multiple-birth handling and recurrent events are absent from the summary and are not newly determined. Related sheets and participants are not summed.
Reason for missing information: Detailed infant/pregnant-woman mapping, multiple-birth handling and recurrent events are absent from the summary and are not newly determined. Related sheets and participants are not summed.
Required materials and conditions: Analysis units for people, pregnancies, infants and birth events, with handling of overlap
Materials to obtain first: Detailed infant/pregnant-woman mapping, multiple-birth handling and recurrent events are absent from the summary and are not newly determined. Related sheets and participants are not summed.
Further research: Obtain original analysis units, pregnancy/birth mapping, exclusions and denominators.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Analysis units for people, pregnancies, infants and birth events, with handling of overlap
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R03

N09 · Are the original 40 (16%) versus 37 (14%) values and arm order maintained?

Current findings: The GRoW evidence list records 40 (16%) versus 37 (14%); the original text also preserves 16% versus 14%.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Denominators are not reverse-calculated from percentages, and events are not increased. Original-summary arm-specific analysis denominators are not explicit.
Reason for missing information: Denominators are not reverse-calculated from percentages, and events are not increased. Original-summary arm-specific analysis denominators are not explicit.
Required materials and conditions: Original arm-specific events, proportions, denominators and outcome tables
Materials to obtain first: Denominators are not reverse-calculated from percentages, and events are not increased. Original-summary arm-specific analysis denominators are not explicit.
Further research: Link original table arm labels, events, denominators and proportions exactly as recorded.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original arm-specific events, proportions, denominators and outcome tables
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R03

N10 · Are adjusted RR, CI and P preserved separately from original proportions?

Current findings: aRR 0.97 (95% CI 0.65 to 1.47), P=0.899 is recorded as originally given.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No crude RR, risk difference or NNT is calculated from original proportions, and reproduction of the adjusted value is not claimed. Adjustment variables and model remain unread.
Reason for missing information: No crude RR, risk difference or NNT is calculated from original proportions, and reproduction of the adjusted value is not claimed. Adjustment variables and model remain unread.
Required materials and conditions: Original material on adjusted effect, model, variables, interval and test
Materials to obtain first: No crude RR, risk difference or NNT is calculated from original proportions, and reproduction of the adjusted value is not claimed. Adjustment variables and model remain unread.
Further research: Obtain adjustment plans, variables, arm-specific denominators and original between-arm effect tables.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original material on adjusted effect, model, variables, interval and test
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R03

N11 · Has a null result been kept separate from confirmed exclusion of meaningful reduction?

Current findings: The original text records no demonstrated birthweight benefit but says meaningful benefit cannot be declared excluded because a validated prespecified clinical threshold is absent.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The aRR CI and P are not converted into certification of zero effect, equivalence or exclusion of meaningful reduction.
Reason for missing information: The aRR CI and P are not converted into certification of zero effect, equivalence or exclusion of meaningful reduction.
Required materials and conditions: A validated prespecified clinical threshold and effect interval
Materials to obtain first: The aRR CI and P are not converted into certification of zero effect, equivalence or exclusion of meaningful reduction.
Further research: Obtain importance criteria, a prespecified validated threshold and plans suited to the population and endpoint.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: A validated prespecified clinical threshold and effect interval
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R03

N12 · Were GRoW allocation and masking details kept separate from EMPOWaR?

Current findings: GRoW’s design is a multicenter double-blind placebo-controlled randomized trial. EMPOWaR has separate allocation and masking quotations.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. EMPOWaR web-based block randomization and study-personnel masking wording are not transferred as actual GRoW details.
Reason for missing information: EMPOWaR web-based block randomization and study-personnel masking wording are not transferred as actual GRoW details.
Required materials and conditions: Trial-specific allocation concealment, masking and outcome-measurement procedures
Materials to obtain first: EMPOWaR web-based block randomization and study-personnel masking wording are not transferred as actual GRoW details.
Further research: Obtain allocation, concealment, measurement and analysis procedures from the original GRoW methods.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Trial-specific allocation concealment, masking and outcome-measurement procedures
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R03

N13 · Are GRoW analysis population, missingness and follow-up methods directly supplied?

Current findings: Only the summary of 524 randomized and 514 analyzed is preserved for GRoW. Explicit modified ITT and 97% belong to the EMPOWaR context.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The EMPOWaR modified-ITT definition is not transferred to GRoW. No new missing-data handling or attrition rate is inferred.
Reason for missing information: The EMPOWaR modified-ITT definition is not transferred to GRoW. No new missing-data handling or attrition rate is inferred.
Required materials and conditions: Original material on ITT status, analysis exclusions, missingness reasons and sensitivity analyses
Materials to obtain first: The EMPOWaR modified-ITT definition is not transferred to GRoW. No new missing-data handling or attrition rate is inferred.
Further research: Obtain GRoW analysis-population definitions, arm exclusions, missing-data handling and sensitivity material.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original material on ITT status, analysis exclusions, missingness reasons and sensitivity analyses
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R03

N14 · Are actual exposure, gastrointestinal symptoms and adherence linked to the birth analysis?

Current findings: The parent record describes gastrointestinal adverse effects and lower adherence.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. GRoW adherence counts or figures and symptom-specific exposure/outcome mapping cannot be verified from the summary. No post hoc adherence effect is newly calculated.
Reason for missing information: GRoW adherence counts or figures and symptom-specific exposure/outcome mapping cannot be verified from the summary. No post hoc adherence effect is newly calculated.
Required materials and conditions: Trial-specific records of actual exposure, adherence, discontinuation and outcomes
Materials to obtain first: GRoW adherence counts or figures and symptom-specific exposure/outcome mapping cannot be verified from the summary. No post hoc adherence effect is newly calculated.
Further research: Obtain actual GRoW exposure, discontinuation and adherence material and the prespecified effect of interest.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Trial-specific records of actual exposure, adherence, discontinuation and outcomes
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R03

N15 · Are birthweight above 4000 g, mean grams and z score the same endpoint?

Current findings: EMPOWaR means of 3462 g versus 3463 g and its adjusted z-score difference of −0.029 are from a different trial and measures. MOP z scores are also preserved separately.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Other trial measures are not filled as direct GRoW birthweight-above-4000-g values. A lower mean is not converted into fewer events.
Reason for missing information: Other trial measures are not filled as direct GRoW birthweight-above-4000-g values. A lower mean is not converted into fewer events.
Required materials and conditions: Separate original definitions, denominators, timepoints and effects for each measure
Materials to obtain first: Other trial measures are not filled as direct GRoW birthweight-above-4000-g values. A lower mean is not converted into fewer events.
Further research: If trial- and measure-specific results are supplied, link original endpoints and denominators separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate original definitions, denominators, timepoints and effects for each measure
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R01 R02 R03

N16 · Are the EMPOWaR primary z-score result and analysis denominators maintained as context?

Current findings: EMPOWaR randomized 449 (226/223) and had 434 in modified ITT; its adjusted z-score difference was −0.029 (95% CI −0.217 to 0.158), P=0.7597.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. These denominators and CI are not copied as birthweight-above-4000-g results. The relevant EMPOWaR event count and effect are absent from this stored summary.
Reason for missing information: These denominators and CI are not copied as birthweight-above-4000-g results. The relevant EMPOWaR event count and effect are absent from this stored summary.
Required materials and conditions: Endpoint, denominator and plan boundaries of another trial
Materials to obtain first: These denominators and CI are not copied as birthweight-above-4000-g results. The relevant EMPOWaR event count and effect are absent from this stored summary.
Further research: If EMPOWaR material for the selected event endpoint is supplied, link it with direct definitions and denominators.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Endpoint, denominator and plan boundaries of another trial
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R01

N17 · Is the MOP z-score report and registration link kept separate from direct evidence for the selected event?

Current findings: MOP z scores of 0.05 versus 0.17, P=0.66 and “400 analyzed” are preserved. The citation URL is the NCT01273584 registration page.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. MOP birthweight-above-4000-g events, effects and arm denominators are not supplied. The registration URL is not labeled as the paper’s full text.
Reason for missing information: MOP birthweight-above-4000-g events, effects and arm denominators are not supplied. The registration URL is not labeled as the paper’s full text.
Required materials and conditions: Distinction between trial-specific bibliographies, material types, endpoints and effects
Materials to obtain first: MOP birthweight-above-4000-g events, effects and arm denominators are not supplied. The registration URL is not labeled as the paper’s full text.
Further research: Obtain registration and the paper separately to link the selected event endpoint, plans and denominators.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Distinction between trial-specific bibliographies, material types, endpoints and effects
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R02

N18 · Are original repeated-null and independence wording distinguished from certification in this work?

Current findings: The parent text records null birthweight results in three trials; GRoW’s original evidence-role wording is independent repeated null evidence.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The three trials with different endpoints are not all counted as direct birthweight-above-4000-g trials. Original axes RX and I1 are not used as new independence certification.
Reason for missing information: The three trials with different endpoints are not all counted as direct birthweight-above-4000-g trials. Original axes RX and I1 are not used as new independence certification.
Required materials and conditions: Links between ingredient, pregnancy without diabetes, trial identity and study families
Materials to obtain first: The three trials with different endpoints are not all counted as direct birthweight-above-4000-g trials. Original axes RX and I1 are not used as new independence certification.
Further research: Link only direct trial-to-endpoint relationships and pass additional material to content review.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Links between ingredient, pregnancy without diabetes, trial identity and study families
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R01 R02 R03

N19 · Do the two related sheets share the same reports, trials and cohorts?

Current findings: The z-score and above-4000-g sheets share the entire stored parent-verdict 2948 summary and three reports.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Reports, participants, trials and repeated measurements are not summed as new independent material because there are two sheets. Unique trials and total participants remain unrecorded.
Reason for missing information: Reports, participants, trials and repeated measurements are not summed as new independent material because there are two sheets. Unique trials and total participants remain unrecorded.
Required materials and conditions: Explicit links between stored summary, bibliographies, trials and participants
Materials to obtain first: Reports, participants, trials and repeated measurements are not summed as new independent material because there are two sheets. Unique trials and total participants remain unrecorded.
Further research: Link additional reports to existing identifiers and preserve same-population relationships.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Explicit links between stored summary, bibliographies, trials and participants
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R01 R02 R03

N20 · Has the birth event been kept separate from later obesity and other clinical pregnancy outcomes?

Current findings: The original text records birthweight as a surrogate for later obesity risk. The fatal composite is a separate harm outcome.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Birthweight-above-4000-g results are not converted into efficacy or null conclusions for later obesity, cesarean delivery, delivery complications or all pregnancy outcomes.
Reason for missing information: Birthweight-above-4000-g results are not converted into efficacy or null conclusions for later obesity, cesarean delivery, delivery complications or all pregnancy outcomes.
Required materials and conditions: Direct distinction between birth measures, long-term clinical outcomes and other pregnancy outcomes
Materials to obtain first: Birthweight-above-4000-g results are not converted into efficacy or null conclusions for later obesity, cesarean delivery, delivery complications or all pregnancy outcomes.
Further research: Each clinical outcome requires separate direct measurement, follow-up, denominators and effects.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Direct distinction between birth measures, long-term clinical outcomes and other pregnancy outcomes
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R01 R03

N21 · Has the verdict’s scope been kept separate from other diabetes treatment and pregnancy management?

Current findings: The original text explicitly states that the verdict does not apply to treatment of gestational or type 2 diabetes and that mechanism explanations do not substitute for birthweight efficacy.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No medication selection, use, dosing, stopping or replacement instructions or pregnancy-management methods are produced.
Reason for missing information: No medication selection, use, dosing, stopping or replacement instructions or pregnancy-management methods are produced.
Required materials and conditions: Direct evidence and boundaries for disease and indication contexts
Materials to obtain first: No medication selection, use, dosing, stopping or replacement instructions or pregnancy-management methods are produced.
Further research: Link evidence for a new indication to its separate population, comparator and endpoint.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Direct evidence and boundaries for disease and indication contexts
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R01 R02 R03

N22 · Are GRoW public funding and gaps in the four company roles distinguished?

Current findings: GRoW funding names the Australian National Health and Medical Research Council; the citation records publicly funded independent replication.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Manufacturer cash support, drug/placebo supply, employee authors and outside analysis-role details are not all filled as absent from this summary.
Reason for missing information: Manufacturer cash support, drug/placebo supply, employee authors and outside analysis-role details are not all filled as absent from this summary.
Required materials and conditions: Separate records for cash support, product provision, affiliated authors and outside analysis providers
Materials to obtain first: Manufacturer cash support, drug/placebo supply, employee authors and outside analysis-role details are not all filled as absent from this summary.
Further research: Obtain original GRoW funding, product supply, affiliations, analysis and writing roles separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate records for cash support, product provision, affiliated authors and outside analysis providers
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R03

N23 · Were EMPOWaR Merck supply and role declarations kept separate from GRoW funding?

Current findings: EMPOWaR MRC·NIHR support, Edinburgh/NHS co-sponsorship, free Merck drug/placebo supply and the no-role declaration are preserved as originally recorded.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. They are not transferred as GRoW or MOP support, supply or analysis declarations. MOP funding retains the ambiguous original wording.
Reason for missing information: They are not transferred as GRoW or MOP support, supply or analysis declarations. MOP funding retains the ambiguous original wording.
Required materials and conditions: Trial-specific relationships of public support, sponsorship, products and company roles
Materials to obtain first: They are not transferred as GRoW or MOP support, supply or analysis declarations. MOP funding retains the ambiguous original wording.
Further research: Link original conflict-of-interest material for the three trials separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Trial-specific relationships of public support, sponsorship, products and company roles
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R01 R02 R03

N24 · Are person, event and exposure denominators available for gastrointestinal harm, discontinuation and adherence?

Current findings: Gastrointestinal adverse effects and lower adherence are recorded in the original safety account.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. GRoW occurrence counts, rates, event relatedness, discontinuation counts and denominators separately remain unread. They are not filled as no adverse effects or safety.
Reason for missing information: GRoW occurrence counts, rates, event relatedness, discontinuation counts and denominators separately remain unread. They are not filled as no adverse effects or safety.
Required materials and conditions: Original trial- and arm-specific harm definition, collection, denominator, discontinuation and exposure tables
Materials to obtain first: GRoW occurrence counts, rates, event relatedness, discontinuation counts and denominators separately remain unread. They are not filled as no adverse effects or safety.
Further research: Obtain original GRoW safety tables and exposure, discontinuation and adherence material.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original trial- and arm-specific harm definition, collection, denominator, discontinuation and exposure tables
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R03

N25 · Has the EMPOWaR fatal composite’s composition and figures been kept separate from GRoW harm?

Current findings: The EMPOWaR miscarriage, pregnancy termination, stillbirth and neonatal-death composite was 7 with metformin versus 2 with placebo, OR 3.60 (95% CI 0.74 to 17.50), P=0.11.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. These figures are not copied as matching GRoW event counts or effects. Component-specific and pregnant-woman/infant denominators remain unread.
Reason for missing information: These figures are not copied as matching GRoW event counts or effects. Component-specific and pregnant-woman/infant denominators remain unread.
Required materials and conditions: Distinction between trials, arms, component events, follow-up and denominators
Materials to obtain first: These figures are not copied as matching GRoW event counts or effects. Component-specific and pregnant-woman/infant denominators remain unread.
Further research: Link each trial’s component event definitions, original arm event tables and denominators.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Distinction between trials, arms, component events, follow-up and denominators
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R01

N26 · Are nonsignificance and wide CIs for rare harm distinguished from confirmed safety?

Current findings: The original text distinguishes confirmed harm from an uncertain signal because of the wide EMPOWaR CI and P=0.11.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The record is not converted into no risk, absence of all harm or confirmed harm. No new harm figure, CI or rate is produced.
Reason for missing information: The record is not converted into no risk, absence of all harm or confirmed harm. No new harm figure, CI or rate is produced.
Required materials and conditions: Material directly addressing effects, precision, exposure and rare harm
Materials to obtain first: The record is not converted into no risk, absence of all harm or confirmed harm. No new harm figure, CI or rate is produced.
Further research: Adequate arm-specific follow-up, component events, original effects and rare-harm material are needed.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Material directly addressing effects, precision, exposure and rare harm
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R01

N27 · Are gaps for maternal, infant and long-term harm and replication material maintained?

Current findings: The current preserved account covers pregnancy and birth-time outcomes and some harm summaries.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new search was made for long-term GRoW maternal or infant follow-up or independent harm-replication material. Long-term safety is not confirmed.
Reason for missing information: No new search was made for long-term GRoW maternal or infant follow-up or independent harm-replication material. Long-term safety is not confirmed.
Required materials and conditions: Direct trial-specific maternal, fetal and neonatal material on long-term exposure and follow-up
Materials to obtain first: No new search was made for long-term GRoW maternal or infant follow-up or independent harm-replication material. Long-term safety is not confirmed.
Further research: Link population-specific direct harm, long-term follow-up and report relationships to original trials.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Direct trial-specific maternal, fetal and neonatal material on long-term exposure and follow-up
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R03

N28 · Are original URLs, registration identifiers and actual reading status shown individually?

Current findings: GRoW preserves its PubMed bibliography URL and ACTRN12612001277831 identifier. MOP connects its actual original registration URL to a separate registration entry.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new URL is constructed from an identifier, and link existence alone does not upgrade a record to completed reading. All external material remains unread.
Reason for missing information: No new URL is constructed from an identifier, and link existence alone does not upgrade a record to completed reading. All external material remains unread.
Required materials and conditions: Individual material entries for summary, abstract, full text, registration, protocol and SAP
Materials to obtain first: No new URL is constructed from an identifier, and link existence alone does not upgrade a record to completed reading. All external material remains unread.
Further research: Link user-obtained original material with its individual material type and access status.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Individual material entries for summary, abstract, full text, registration, protocol and SAP
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R01 R02 R03

N29 · Are reference date, original languages, corrections, empty values and parent history preserved?

Current findings: The reference date 2026-08-26, empty correction array and empty deliberation string, Korean/English text, parent D30 with safety Caution, and original axes are preserved.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. This production date is not changed into a clinical-verification date, and past cross-checks are not marked as passing this work’s content review.
Reason for missing information: This production date is not changed into a clinical-verification date, and past cross-checks are not marked as passing this work’s content review.
Required materials and conditions: Separate preservation of the entire stored summary, selected verdict record and parent values
Materials to obtain first: This production date is not changed into a clinical-verification date, and past cross-checks are not marked as passing this work’s content review.
Further research: Reflect new material and decisions as separate change events while preserving the entire original.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate preservation of the entire stored summary, selected verdict record and parent values
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R01 R02 R03

N30 · Is the incomplete content-review marker distinguished from actual production and independence status?

Current findings: Existing review-pending, production-eligibility and boundary-review-needed values are preserved as history. The original content review is incomplete; the original model, content and boundary active-pending and completion markers are false.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. There is no new verdict, split or independence certification; additional new units remain 0 and the final independent count unrecorded.
Reason for missing information: There is no new verdict, split or independence certification; additional new units remain 0 and the final independent count unrecorded.
Required materials and conditions: Separate records of original candidate history, production status and review status
Materials to obtain first: There is no new verdict, split or independence certification; additional new units remain 0 and the final independent count unrecorded.
Further research: Reflect only user-provided decisions and materials as separate events.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate records of original candidate history, production status and review status
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Fewer births above 4000 g

Related sources R01 R02 R03