Safety of Metformin in Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

950 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Pregnancy Pregestational Diabetes Polycystic Ovary Syndrom

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant patient exposed to 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)).

metformin

Intervention Type DRUG

This is not an intervention but an observed exposure.

Reference group

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.

any drug not known as a major teratogen or major fetotoxicant

Intervention Type DRUG

This is not an intervention but an observed exposure.

Interventions

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metformin

This is not an intervention but an observed exposure.

Intervention Type DRUG

any drug not known as a major teratogen or major fetotoxicant

This is not an intervention but an observed exposure.

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No