Evidence map›Paper›PMID 35354633›Full record

ArticleBMJ open2022

Pregnancy Outcomes: Effects of Metformin (POEM) study: a protocol for a long-term, multicentre, open-label, randomised controlled trial in gestational diabetes mellitus.

Eline G M van Hoorn, Peter R van Dijk, Jelmer R Prins, Helen L Lutgers, Klaas Hoogenberg, Jan Jaap H M Erwich, Adriaan Kooy

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02947503. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 34% 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.

NCT02947503 phase3recruiting

Pregnancy Outcomes: Effects of Metformin Study (POEM Study), a Long Term Randomized Controlled Study in Gestational Diabetes

Ran2019Enrolled500Registered outcomes7Posted comparisons0ConditionsGestational Diabetes, Insulin ResistanceArmsMetformin TEVA 850 mg
Open the trial in the graph
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Hyperglycemia in Pregnancy and Women's Health in the 21st Century.International journal of environmental research and public health · 2022
    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

7 authors at 3 institutions in 1 country.

Eline G M van HoornDepartment of Endocrinology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands e.g.m.van.hoorn@umcg.nl.ORCID 0000-0002-1065-8231
Peter R van DijkDepartment of Endocrinology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.ORCID 0000-0002-9702-6551
Jelmer R PrinsDepartment of Obstetrics and Gynaecology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.ORCID 0000-0002-3984-2163
Helen L LutgersDepartment of Internal Medicine, Medical Centre Leeuwarden, Leeuwarden, Netherlands.
Klaas HoogenbergDepartment of Internal Medicine, Martini Hospital, Groningen, Netherlands.
Jan Jaap H M ErwichDepartment of Obstetrics and Gynaecology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.ORCID 0000-0003-1362-4501
Adriaan KooyDepartment of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.ORCID 0000-0002-8853-0019
University Medical Center Groningen · NLMartini Ziekenhuis · NLMedisch Centrum Leeuwarden · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGestational diabetes mellitus (GDM) is a common disorder of pregnancy with health risks for mother and child during pregnancy, delivery and further lifetime, possibly leading to type 2 diabetes mellitus (T2DM). Current treatment is focused on reducing hyperglycaemia, by dietary and lifestyle intervention and, if glycaemic targets are not reached, insulin. Metformin is an oral blood glucose lowering drug and considered safe during pregnancy. It improves insulin sensitivity and has shown advantages, specifically regarding pregnancy-related outcomes and patient satisfaction, compared with insulin therapy. However, the role of metformin in addition to usual care is inconclusive and long-term outcome of metformin exposure in utero are lacking. The primary aim of this study is to investigate the early addition of metformin on pregnancy and long-term outcomes in GDM. METHODS AND ANALYSIS: The Pregnancy Outcomes: Effects of Metformin study is a multicentre, open-label, randomised, controlled trial. Participants include women with GDM, between 16 and 32 weeks of gestation, who are randomised to either usual care or metformin added to usual care, with insulin rescue in both groups. Metformin is given up to 1 year after delivery. The study consists of three phases (A-C): A-until 6 weeks after delivery; B-until 1 year after delivery; C-observational study until 20 years after delivery. During phase A, the primary outcome is a composite score consisting of: (1) pregnancy-related hypertension, (2) large for gestational age neonate, (3) preterm delivery, (4) instrumental delivery, (5) caesarean delivery, (6) birth trauma, (7) neonatal hypoglycaemia, (8) neonatal intensive care admission. During phase B and C the primary outcome is the incidence of T2DM and (weight) development in mother and child. ETHICS AND DISSEMINATION: The study was approved by the Central Committee on Research Involving Human Subjects in the Netherlands. Results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02947503.

Indexed as

Diabetes, GestationalDiabetes Mellitus, Type 2MetforminFemaleHumansHypoglycemic AgentsInfant, NewbornInsulinMulticenter Studies as TopicObservational Studies as TopicPregnancyRandomized Controlled Trials as TopicHypoglycemic AgentsInsulinMetformindiabetes in pregnancyobstetricspaediatrics

Identifiers

PMID35354633
PMCPMC8968576
OpenAlexW4220829161

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

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 Socratic graph.