Fetotoxicity of NSAIDS and RAAS-inhibitors in the 2nd and 3rd trimester of pregnancy (fetopathy approach)
- Conditions
- MedDRA - 10049996 Ductus arteriosus premature closureMedDRA - 10013808 Ductus arteriosus stenosis fetalMedDRA - 10050701 Congenital pulmonary hypertensionO41.0P01.2OligohydramniosFetus and newborn affected by oligohydramnios
- Registration Number
- DRKS00011568
- Lead Sponsor
- Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 377
Inclusion Criteria
Patients with during prenancy confirmed study diagnoses (oligohydramnios, narrowing or premature closure of the ductus arteriosus, pulmonary Hypertension) or the concomitant diseases of the newborn (neonatal or fetal right heart strain).
Exclusion Criteria
oligohydramnios with premature rupture of membranes
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Can the hypothesis of an fetopathy (oligo- /anhydramnion or premature narrowing/closure of the ductus arteriosus after exposure to certain medications (NSAIDS, metamizole, RAAS-inhibitors) in the 2nd/3rd Trimester be confirmed and if so, can the risk for this be estimated?<br>2. When in the second half of pregnancy is the sensitive period for fetotoxicity related to the above mentioned medications?<br>Information regarding this question is collected by means of a questionnaire during and after pregnancy.
- Secondary Outcome Measures
Name Time Method 1. Are there any signs of a minimum exposure time and/or a minimum dose before fetopathy develops?<br>2. Are there any other fetotoxic effects besides the known diagnostic findings of RAAS Inhibitor fetopathy?<br>Information regarding this question is collected by means of a questionnaire during and after pregnancy.