Evidence map›Paper›PMID 29215149›Full record

Observational studyBritish journal of clinical pharmacology2018

Pregnancy outcomes in women on metformin for diabetes or other indications among those seeking teratology information services.

Alice Panchaud, Valentin Rousson, Thierry Vial, Nathalie Bernard, David Baud, Emmanuelle Amar, Marco De Santis, Alessandra Pistelli, Anne Dautriche, Frederique Beau-Salinas and 13 more

Open access · bronzeAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
4.8field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Observational
  5. Article
  6. Metformin use in pregnancy: efficacy, safety, and potential benefits.Journal of endocrinological investigation · 2023
    Article
  7. Observational
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Frontiers in endocrinology · 2021
    Article
  14. Article
  15. Observational
  16. Article
  17. Article
  18. Article
  19. Observational
  20. Observational
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

23 authors at 18 institutions in 10 countries.

Alice PanchaudSchool of Pharmaceutical Sciences, University of Geneva and Lausanne, Geneva, Switzerland.ORCID 0000-0001-6086-2401
Valentin RoussonInstitute of Social and Preventive Medicine (IUMSP), Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Thierry VialPharmacovigilance Center of Lyon, Hospices Civils de Lyon, France.
Nathalie BernardPharmacovigilance Center of Lyon, Hospices Civils de Lyon, France.
David BaudMaterno-Fetal and Obstetrics Research Unit, Departement "Femme-Mere-Enfant", University Hospital, Lausanne, Switzerland.
Emmanuelle AmarRegistre des Malformations en Rhone Alpes (REMERA), Faculté Laennec, Lyon, France.
Marco De SantisTelefono Rosso-Teratology Information Service, Department of Obstetrics and Gynecology, Catholic University of Sacred Heart, Rome, Italy.
Alessandra PistelliCentro di Riferimento Regionale di Tossicologia Perinatale, SODc Tossicologia Medica, Azienda Ospedaliero Universitaria Careggi, Firenze, Italy.
Anne DautrichePharmacovigilance Center of Dijon, CHU, Dijon, France.
Frederique Beau-SalinasPharmacovigilance Center of Tours, CHRU, Tours, France.
Matteo CassinaTeratology Information Service, Clinical Genetics Unit, Department of Women's and Children's Health, University of Padova, Padova, Italy.
Hannah DunstanUKTIS, Regional Drug and Therapeutics Centre, Newcastle upon Tyne, UK.
Anneke PassierTeratology Information Service (TIS), Netherlands Pharmacovigilance Centre Lareb, The Netherlands.
Yusuf Cem KaplanFaculty of Medicine Department of Pharmacology Teratology Information Service, Izmir Katip Celebi University, Izmir, Turkey.ORCID 0000-0003-0369-7934
Mine Kadioglu DumanFaculty of Medicine, Department of Pharmacology, Karadeniz Technical University, Trabzon, Turkey.
Eva MaňákováCZTIS, 3rd Faculty of Medicine, Charles University, Prague, Czech Republic.
Georgios EleftheriouPoison Control Center, Bergamo, Italy.
Gil KlingerBELTIS, Rabin Medical Center and NICU, Schneider Children's Medical Center of Israel, Petach Tikva, Israel and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Ursula WinterfeldSwiss Teratogen Information Service (STIS) and Service of Clinical Pharmacology, University Hospital, Lausanne, Switzerland.
Laura E RothuizenSwiss Teratogen Information Service (STIS) and Service of Clinical Pharmacology, University Hospital, Lausanne, Switzerland.
Thierry BuclinSwiss Teratogen Information Service (STIS) and Service of Clinical Pharmacology, University Hospital, Lausanne, Switzerland.
Chantal CsajkaSchool of Pharmaceutical Sciences, University of Geneva and Lausanne, Geneva, Switzerland.
Sonia Hernandez-DiazDepartment of Epidemiology, Harvard School of Public Health, Boston, Massachusetts, USA.
Swiss Finance Institute · CHHospices Civils de Lyon · FRUniversity of Geneva · CHAzienda Ospedaliero-Universitaria Careggi · ITCentre Hospitalier Universitaire de Tours · FRCharles University · CZCHU Dijon Bourgogne · FRe-Therapeutics (United Kingdom) · GBHarvard University · USHôpital de l'enfance · CHIzmir Kâtip Çelebi University · TRKaradeniz Technical University · TRNetherlands Pharmacovigilance Centre Lareb · NLTel Aviv University · ILUniversità Cattolica del Sacro Cuore · ITUniversity Hospital of Lausanne · CHUniversity of Bergamo · ITUniversity of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsMetformin is used to treat type 2 diabetes, polycystic ovary syndrome associated infertility, and gestational diabetes. This study aims to evaluate the safety of metformin in early pregnancy.

methodWe evaluated the risk of major birth defects and pregnancy losses in a cohort of pregnant women exposed to metformin during the first trimester for different indications relative to a matched unexposed reference group.

resultsThe risk of major birth defects was 5.1% (20/392) in pregnancies exposed to metformin during the first trimester and 2.1% (9/431) in the reference group [adjusted odds ratio (OR) 1.70; 95% CI 0.70-4.38]. Among metformin users, this risk was 7.8% (17/219) in patients with pre-gestational diabetes and 1.7% (3/173) in those without this diagnosis. Compared to the unexposed reference, the OR for metformin user with diabetes was 3.95 (95% CI 1.77-9.41) and for metformin with other indications it was 0.83 (95% CI 0.18-2.81). The risk of pregnancy losses (spontaneous abortions and stillbirths) was 20.8% in women on metformin during the first trimester and 10.8% in the reference group [adjusted hazard ratio (HR) 1.57; 95% CI 0.90-2.74]. The risks for women on metformin with and without pre-gestational diabetes were 24.0% and 16.8% respectively, with adjusted HR of 2.51 (95% CI 1.44-4.36) and 1.38 (95% CI 0.74-2.59) when compared to the reference.

conclusionPregnant women with pre-gestational diabetes on metformin are at a higher risk for adverse pregnancy outcomes than the general population. This appears to be due to the underlying diabetes since women on metformin for other indications do not present meaningfully increased risks.

Indexed as

Pregnancy OutcomeAbortion, SpontaneousAdultCohort StudiesFemaleHumansHypoglycemic AgentsMetforminPregnancyPregnancy ComplicationsPregnancy in DiabeticsPregnancy Trimester, FirstProspective StudiesStillbirthHypoglycemic AgentsMetformindiabetesmetforminobservational studypregnancyspontaneous abortionteratogen

Identifiers

PMID29215149
PMCPMC5809340
OpenAlexW2775083822

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.