Pregnancy outcome after first-trimester exposure to metformin: the experience of the Berlin institute for clinical teratology and drug risk assessment in pregnancy

• Conditions: congenital malformations/spontaneous abortions after intrauterine metformin exposure; Q89.9; O03; Congenital malformation, unspecified; Spontaneous abortion

• Registration Number: DRKS00007621
• Lead Sponsor: Pharmakovigilanz- und Beratungszentrum für EmbryonaltoxikologieCharité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 1500

Inclusion Criteria

Both cohorts: prospectively ascertained pregnancies, i.e. outcome of pregnancy is unknown at the time of contact to the study centre; study cohort: metformin exposure during the first trimester of pregnancy; control cohort: control group without metformin therapy

Exclusion Criteria

malignancies, exposure to established teratogens (lenalidomide, carbamazepine, methotrexate, mycophenolate, phenobarbital, phenprocoumon, phenytoin, retinoids (acitretin, adapalen, isotretinoin, tazaroten, tretinoin), thalidomide, topiramate, warfarin) or fetotoxicants (angiotensin-converting enzyme (ACE)-inhibitors and angiotensin II receptor antagonists) after the first trimester; valproaic acid-exposed pregnancies will be evaluated separately (patients may be prone to PCOS)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of major congenital malformations (detection up to 8 weeks after birth) and of spontaneous fetal loss

Secondary Outcome Measures

Name	Time	Method
premature birth, birth weight, and pregnancy complications