Evidence map›Paper›PMID 39215812›Full record

Trial reportDiabetologia2024

Metformin and small for gestational age babies: findings of a randomised placebo-controlled clinical trial of metformin in gestational diabetes (EMERGE).

Fidelma Dunne, Christine Newman, Alberto Alvarez-Iglesias, Paula O'Shea, Declan Devane, Paddy Gillespie, Aoife Egan, Martin O'Donnell, Andrew Smyth

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetologia, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02980276. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02980276 phase3completed

A Randomised Placebo Controlled Trial of the Effectiveness of Early MEtformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects (EMERGE)

Ran2017Enrolled535Registered outcomes34Posted comparisons42ConditionsGestational DiabetesArmsMetformin hydrochloride, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Fidelma DunneCollege of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland. Fidelma.dunne@universityofgalway.ie.
Christine NewmanCollege of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland.
Alberto Alvarez-IglesiasHRB Clinical Research Facility Galway, University of Galway, Galway, Ireland.
Paula O'SheaCollege of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland.
Declan DevaneCollege of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland.
Paddy GillespieSchool of Business and Economics, University of Galway, Galway, Ireland.
Aoife EganCollege of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland.
Martin O'DonnellCollege of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland.
Andrew SmythCollege of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland.

Funding

Elucidating the Pathophysiology of Gestational Diabetes MellitusK23DK134767 · NIDDK · MAYO CLINIC ROCHESTER · PI Aoife Maria Egan · 2023 to 2026
$762k
NIDDK NIH HHS K23 DK134767
6 · The paper itself

Abstract

aims/hypothesisGestational diabetes mellitus (GDM) is associated with adverse perinatal outcomes because of suboptimal glucose management and glucose control and excessive weight gain. Metformin can offset these factors but is associated with small for gestational age (SGA) infants. We sought to identify risk factors for SGA infants, including the effect of metformin exposure on SGA status.

methodsIn this prespecified secondary analysis of the EMERGE trial, which evaluated the effectiveness of metformin vs placebo in treating GDM and found reduced gestational weight gain and longer time to insulin initiation with metformin use, we included women with a live-born infant and known infant birthweight and gestational age at delivery. We compared the numbers of SGA infants in both groups and explored baseline predictive factors to help identify those at highest risk of delivering an SGA infant.

resultsBaseline maternal characteristics were similar between SGA and non-SGA pregnancies. On multivariable-adjusted regression, no baseline maternal variables were associated with SGA status. Mothers of SGA infants were more likely to develop pre-eclampsia or gestational hypertension (18.2% vs 2.0%, p=0.001; 22.7% vs 5.4%, p=0.005, respectively); after multivariable adjustment, pre-eclampsia was positively associated with SGA status). Among SGA pregnancies, important perinatal outcomes including preterm birth, Caesarean delivery and neonatal care unit admission did not differ between the metformin and placebo groups (20.0% vs 14.3%, p=1.00; 50.0% vs 28.6%, p=0.25; 13.3% vs 42.9%, p=0.27, respectively). CONCLUSIONS/

interpretationPre-eclampsia was strongly associated with SGA infants. Metformin-exposed SGA infants did not display a more severe SGA phenotype than infants treated with placebo.

trial registrationClinical Trials.gov NCT02980276; EudraCT number: 2016-001644-19.

Indexed as

Diabetes, GestationalHypoglycemic AgentsInfant, Small for Gestational AgeMetforminAdultBirth WeightFemaleGestational AgeGestational Weight GainHumansInfant, NewbornPregnancyPregnancy OutcomeRisk FactorsHypoglycemic AgentsMetforminGestational diabetesMetforminSmall for gestational age

Identifiers

PMID39215812
PMCPMC11604746

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.