Pregnancy outcome after first trimester exposure to fosfomycin - a prospective cohort study
Completed
- Conditions
- Q89.9O03Congenital malformation, unspecifiedSpontaneous abortion
- Registration Number
- DRKS00013159
- Lead Sponsor
- Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 608
Inclusion Criteria
Prospectively ascertained pregnancies, which means neither the outcome of pregnancy nor prenatal pathologic findings are known at date of recruitment.
Study group: fosfomycin exposure during first trimester. Control group: Patients without exposure of the study drug
Exclusion Criteria
Exclusion criteria (applies for the exposed and the comparison group): Exclusion of cases with maternal exposure considered as potent teratogens or fetotoxicants or malignant diseases.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method