Safety of Metformin in Pregnancy

Completed

• Conditions: Pregnancy; Polycystic Ovary Syndrom; Pregestational Diabetes
• Interventions: Drug: any drug not known as a major teratogen or major fetotoxicant; Drug: metformin

• Registration Number: NCT02793505
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-11
• Study First Submitted: 2016-05-25
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-02
• Last Update Submitted: 2016-06-02
• Study First Posted: 2016-06-08
• Last Update Posted: 2016-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 950

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Reference group	any drug not known as a major teratogen or major fetotoxicant	Pregnant women seeking counseling by themselves or through their healthcare provider for exposure to any drug not known as a major teratogen or fetotoxicant and different than metformin, insulin or any other hypoglycaemic agent.
Pregnant patient exposed to metformin	metformin	Pregnant women seeking counseling by themselves or through their healthcare provider for exposure to metformin (Anatomical Therapeutic Chemical A10BA02) any time during pregnancy (i. e. any time from conception to week 42 after last menstrual period (LMP)).

Primary Outcome Measures

Name	Time	Method
Major birth defects	within two weeks after birth or at histopathological exam in case of late spontaneous abortion or stillbirth occuring in pregnancy
Spontaneous abortion	until 20 weeks of pregnancy

Secondary Outcome Measures

Name	Time	Method
Minor birth defects	within two weeks after birth
Preterm birth	after 24 weeks of pregnancy
Pregnancy complications	after 12 weeks of pregnancy until delivery