Outcome of pregnancies exposed to the selective progesterone receptor modulator ulipristal acetate - Evalutation of the national Embryotox cohort

• Conditions: Q89.9; O03; Congenital malformation, unspecified; Spontaneous abortion

• Registration Number: DRKS00015155
• Lead Sponsor: Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-25
• Study Completion: 2019-07-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 226

Inclusion Criteria

Unintended pregnancies after postcoital contraception with UPA or myoma-therapy

Exclusion Criteria

None.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description and evaluation of: <br>a) congenital birth defects after exposure to the study medication during 1st trimester. <br>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. <br>Final endpoint will be June 2021. <br>

Secondary Outcome Measures

Name	Time	Method
Description and determination of <br>a) possible reasons for failed emergency contraception, e.g. because of maternal characteristics (high BMI) or inadequate application time <br>b) possible reasons for failed medical termination of pregnancy