Evidence map›Paper›PMID 32039724›Full record

Trial reportBMC pediatrics2020

Cognitive function in metformin exposed children, born to mothers with PCOS - follow-up of an RCT.

Hanne Klæboe Greger, Liv Guro Engen Hanem, Heidi Furre Østgård, Eszter Vanky

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pediatrics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00159536 (Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
4.7field-weighted citation impact, top 4% of its field
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.

NCT00159536 phase3completednot on this map

Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome (PCOS)

TypeinterventionalSponsorNorwegian University of Science and TechnologyRan2005 to 2009Enrolled257ConditionsPolycystic Ovary SyndromeArmsMetformin, Placebo
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 57 citations in OpenAlex.

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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

4 authors at 2 institutions in 1 country.

Hanne Klæboe GregerDepartement of Mental Health, Faculty of Medicine and Health Sciences, NTNU -Norwegian University of Science and Technology, Trondheim, Norway. Hanne.k.greger@ntnu.no.ORCID 0000-0003-1783-0847
Liv Guro Engen HanemSt.Olavs Hospital, Trondheim, Norway.
Heidi Furre ØstgårdSt.Olavs Hospital, Trondheim, Norway.
Eszter VankySt.Olavs Hospital, Trondheim, Norway.
Norwegian University of Science and Technology · NOSt Olav's University Hospital · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetformin is widely used in pregnancy to treat gestational diabetes mellitus and polycystic ovary syndrome (PCOS). Association between PCOS and developmental delay in offspring, and larger head circumference of metformin-exposed newborns has been reported. The objective of this study was to explore whether metformin exposure in utero had any effect on offspring cognitive function.

methodThe current study is a follow-up of two randomized, placebo-controlled studies which were conducted at 11 public hospitals in Norway In the baseline studies (conducted in 2000-2003, and 2005-2009), participants were randomized to metformin 1700 and 2000 mg/d or placebo from first trimester to delivery. There was no intervention in the current study. We invited parents of 292 children to give permission for their children to participate; 93 children were included (mean age 7.7 years). The follow-up study was conducted in 2014-2016. The Wechsler Preschool and Primary Scale of Intelligence version III and the Wechsler Intelligence Scale for Children version IV were applied for cognitive assessment. Androstenedione and testosterone were measured in maternal blood samples at four time-points in pregnancy.

resultsWe found no difference in mean, full scale IQ in metformin (100.0 (SD 13.2)) vs. placebo-exposed (100.9 (SD 10.1)) children. There was an association between metformin exposure in utero and borderline intellectual function of children (full scale IQ between 70 and 85). Free testosterone index in gestational week 19, and androstenedione in gestational week 36 correlated positively to full scale IQ.

conclusionsWe found no evidence of long-term effect of metformin on average child cognitive function. The increase of borderline intellectual functioning in metformin-exposed children must be interpreted with caution due to small sample size.

trial registrationThe baseline study was registered on 12 September 2005 at the US National Institute of Health (ClinicalTrials.gov) # NCT00159536.

Indexed as

CognitionHypoglycemic AgentsMetforminPolycystic Ovary SyndromeAdultChildChild, PreschoolFemaleFollow-Up StudiesHumansInfant, NewbornMaleMothersNorwayPregnancyHypoglycemic AgentsMetforminAndrogenMetforminOffspring cognitive functionPCOS

Identifiers

PMID32039724
PMCPMC7008569
OpenAlexW3009517525

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.