Safety of Metformin in Pregnancy

Vaud University Hospital Center

Status: Completed

Conditions: Pregestational Diabetes; Polycystic Ovary Syndrom; Pregnancy

Treatments: Drug: any drug not known as a major teratogen or major fetotoxicant; Drug: metformin

Study type: Observational

Funder types: Other

Identifiers

NCT02793505

STIS-05

Details and patient eligibility

About

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.

Enrollment: 950 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

950 participants in 2 patient groups

Pregnant patient exposed to metformin

Description:

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)).

Treatment:

Drug: metformin

Reference group

Description:

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.

Treatment:

Drug: any drug not known as a major teratogen or major fetotoxicant