DRKS00007621
Not yet recruiting
Not Applicable
Pregnancy outcome after first-trimester exposure to metformin: the experience of the Berlin institute for clinical teratology and drug risk assessment in pregnancy
Pharmakovigilanz- und Beratungszentrum für EmbryonaltoxikologieCharité - Universitätsmedizin Berlin0 sites1,500 target enrollmentAugust 27, 2015
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- congenital malformations/spontaneous abortions after intrauterine metformin exposure
- Sponsor
- Pharmakovigilanz- und Beratungszentrum für EmbryonaltoxikologieCharité - Universitätsmedizin Berlin
- Enrollment
- 1500
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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