Safety of Metformin in Pregnancy

Centre Hospitalier Universitaire Vaudois950 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

950

Conditions

Pregnancy Pregestational Diabetes Polycystic Ovary Syndrom

Interventions

metforminDRUG

This is not an intervention but an observed exposure.

any drug not known as a major teratogen or major fetotoxicantDRUG

This is not an intervention but an observed exposure.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Outcomes

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

Data from ClinicalTrials.gov

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