congenital malformations/spontaneous abortions after intrauterine metformin exposure Q89.9 O03
Conditions
Interventions
Group 1: Prospectively ascertained pregnancies with metformin exposure in the first trimester
existing data from the archive of the isntitute are analyzed for this study
Group 2: Control group: Prospectively ascertained pregnancies without any metformin therapy
the control group will be frequency-matched to the study group according to BMI and year of ascertainment
existing data from the archive of the institute are analyzed for this study
Sponsors
Pharmakovigilanz- und Beratungszentrum für EmbryonaltoxikologieCharité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
Female
Inclusion 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of major congenital malformations (detection up to 8 weeks after birth) and of spontaneous fetal loss | — |
Secondary
| Measure | Time frame |
|---|---|
| premature birth, birth weight, and pregnancy complications | — |
Countries
Germany
Contacts
Public ContactChristof Schaefer
Pharmakovigilanz- und Beratungszentrum für EmbryonaltoxikologieCharité - Universitätsmedizin Berlin
Outcome results
None listed