Effects of antihypertensive therapy on pregnancy outcome – An observational cohort study of the Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie Berli
Recruiting
- Conditions
- Congenital malformations and spontaneous abortions after antihypertensive therapy in the first trimester of pregnancy.Q89.9O03Congenital malformation, unspecifiedSpontaneous abortion
- Registration Number
- DRKS00010502
- Lead Sponsor
- Pharmakovigilanz- und Beratungszentrum Embryonaltoxikologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 5500
Inclusion Criteria
prospectively ascertained pregnancy
Exclusion Criteria
Exclusion of concomitant therapy with known teratogens or fetotoxic drugs: carbamazepine, lenalidomide, methotrexate,mycophenolate, phenobarbital, phenytoin, retinoids, thalidomide, topiramate, valproate, ARBs (AT1-antagonists)* and ACE-inhibitors*. In addition malignant diseases are defined as exclusion criterion.
Therapy with ARBs (AT1-antagonists) and ACE-inhibitors* in the first trimester is only possible in the corresponding study groups of these substances, but pregnancies with continued therapy after week 20 are excluded.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method