Q89.9 O03
Conditions
Interventions
Group 1: Evaluation and description of pregnancy- outcomes after failed postcoital contraception with UPA (ulipristal acetate) (single dose 30 mg/d) or after Uterus myomatosus-treatment (daily 5 mg/d)
Sponsors
Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Unintended pregnancies after postcoital contraception with UPA or myoma-therapy
Exclusion criteria
Exclusion criteria: None.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Description and evaluation of: a) congenital birth defects after exposure to the study medication during 1st trimester. b) spontaneous abortions, elective terminations of pregnancy and other adverse pregnancy outcomes after exposure to the study medication at any time during pregnancy. 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. Final endpoint will be June 2021. | — |
Secondary
| Measure | Time frame |
|---|---|
| Description and determination of a) possible reasons for failed emergency contraception, e.g. because of maternal characteristics (high BMI) or inadequate application time b) possible reasons for failed medical termination of pregnancy | — |
Countries
Germany
Contacts
Public ContactJenny Katharina Wagner
Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin Berlin
Outcome results
None listed