Pregnancy outcome after 1st trimester exposure to statins - an evaluation based on the Embryotox cohort database
- Conditions
- Q89.9O03P95Congenital malformation, unspecifiedSpontaneous abortionFetal death of unspecified cause
- Registration Number
- DRKS00029177
- Lead Sponsor
- Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- Female
- Target Recruitment
- 840
For both cohorts: Enrollment of pregnancies, of which neither the outcome nor pathological results of prenatal diagnostics are known at the first contact. First contact during the study period 01.01.2000- 30.06.2021. Information on the outcome of pregnancy is completed. The quality of the information/data must comply with internal standards.
Malignancies; Cases with maternal exposure to considered potent teratogens or fetotoxicants: i.e. valproate, topiramate and carbamazepine as well as acenocoumarol, ACE-inhibitors and AT1- antagonists (exposure in 2nd and 3rd trimester), lenalidomide, methotrexate, mycophenolate, phenobarbital, phenprocoumon, phenytoin, retinoids (acitretin, adapalen, isotretinoin, tazaroten, tretinoin), thalidomide and warfarin.
Missing data on pregnancy outcome.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To analyse the risk of major congenital birth defects and spontaneous abortions after 1st trimester exposure to statins.
- Secondary Outcome Measures
Name Time Method To estimate the risk of low birth weight, gestational age at delivery (preterm birth) and pregnancy complications (i.e. preeclampsia, gestational diabetes).<br><br>All outcomes are assessed with a questionnaire eight weeks after the estimated date of birth<br>