Safety of Metformin in Pregnancy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02793505

Enrollment

950

Registered

2016-06-08

Start date

2014-01-31

Completion date

Unknown

Last updated

2016-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrom, Pregestational Diabetes, Pregnancy

Keywords

metformin, pregnancy outcomes, birth defects, spontaneous abortion, pharmacoepidemiology

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.

Interventions

DRUGmetformin

This is not an intervention but an observed exposure.

DRUGany drug not known as a major teratogen or major fetotoxicant

This is not an intervention but an observed exposure.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026