Q89.9 O03
Conditions
Interventions
Group 1: Prospectively ascertained pregnancies with maternal fosfomycin treatment during first trimester. Exclusion of cases with maternal exposure considered as potent teratogens or fetotoxicants or
Sponsors
Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
Eligibility
Sex/Gender
Female
Inclusion criteria
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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Is Fosfomycin exposure during first trimester associated with an increased risk of birth defects compared to a non-exposed comparison group? Is fosfomycin exposure during first trimester associated with an increased risk of spontaneous abortion compared to a non-exposed comparison group? Using a structured questionnaire, at first contact with our institute all relevant data are documented. 8 weeks after the expected date of delivery follow-up is conducted using a mailed questionnaire covering complications of pregancy or delivery, pediatric check up, and congenital anomalies. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are preterm delivery or lower birth weight after fosfomycin exposure during first trimester. | — |
Countries
Germany
Contacts
Public ContactWayan Philipps
Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
Outcome results
None listed