Safety of Metformin in Pregnancy

This study aims to better characterize the risk linked to metformin use during pregnancy, using a prospective multicentric cohort design enabling a large sample size, in evaluating the rate of birth defects after first trimester exposure, as well as several other pregnancy related outcomes.

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Key information

Conditions

Pregnancy Abortion, Spontaneous Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Polycystic Ovary Syndrom Pregestational Diabetes Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Exposed group: exposed to metformin (Anatomical Therapeutic Chemical A10BA02) any time during pregnancy (i. e. any time from conception to week 42 after last menstrual period (LMP)).
Reference group: at no time during pregnancy were exposed to metformin, insulin or any other hypoglycaemic agent.

Exclusion criteria

exposed to any of the following known major teratogen or major fetotoxicant: acitretin, isotretinoin, mycophenolate, thalidomide, valproic acid, angiotensin-II receptor blockers (only when used in 2nd or 3rd trimester), ACE inhibitors (only when used in 2nd or 3rd trimester), or (b) following treatment indications coded: malignancies (MedDRA code: malignant or unspecified tumors (SMQ 20000091), ICD-10: C00-D09)) or malignancy related conditions (MedDRA: SMQ 20000092), ICD-10: C00-D09).
lost to follow-up

Treatment and study plan

metformin

Drug

This is not an intervention but an observed exposure.

any drug not known as a major teratogen or major fetotoxicant

Drug

This is not an intervention but an observed exposure.

Primary outcomes

Major birth defects

Time frame: within two weeks after birth or at histopathological exam in case of late spontaneous abortion or stillbirth occuring in pregnancy
Spontaneous abortion

Time frame: until 20 weeks of pregnancy

Secondary outcomes

Minor birth defects

Time frame: within two weeks after birth
Preterm birth

Time frame: after 24 weeks of pregnancy
Pregnancy complications

Time frame: after 12 weeks of pregnancy until delivery

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

Pregnancy Outcome Following Maternal Exposure to Metformin: a Collaborative ENTIS Study

Important dates

Study start: 2014
Primary completion: 2015
First posted: Jun 8, 2016
Registry last updated: Jun 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed