DRKS00032881
Completed
Not Applicable
Observational cohort study of pregnancy outcomes after intrauterine exposure to clindamycin based on the Embryotox cohort
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie0 sites400 target enrollmentJanuary 3, 2024
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Q89.9
- Sponsor
- Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie
- Enrollment
- 400
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For study cohorts: Enrollment of pregnancies, of which neither the outcome nor pathological results of prenatal diagnostics are known at the first contact. First contact with the Embryotox Center of Clinical Teratology and Drug Safety in Pregnancy, Berlin during the study period 01\.01\.2000\- 31\.07\.2023\. Information on the outcome of pregnancy is completed. The quality of the information/data must comply with internal standards.
Exclusion Criteria
- •Exclusion criteria (applies for the exposed cohort and the control cohorts):
- •\-Malignant diseases
- •\-Exposure to proven teratogens \[acenocoumarol, carbamazepine, lenalidomide, methotrexate, mycophenolate, phenobarbital, phenprocoumon, phenytoin, retinoids (acitretin, adapalene, alitretinoin, isotretinoin, tazarotene, tretinoin, trifarotene), topimarate, thalidomide, valproic acid, warfarin]; Exposure to fetotoxic substances in the second and/or third trimester \[angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists]
- •\-Topical/cutaneous application of clindamycin (exception: vaginal application)
- •\-Indication for clindamycin treatment due to pathological pregnancy complications (e.g. preterm labour, premature rupture of membranes) caused by infection in late pregnancy
- •\-Insufficient data on pregnancy outcome or non\-plausible, missing relevant data
Outcomes
Primary Outcomes
Not specified
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