Evaluating ulipristal acetate and misoprostol for induced abortion through 63 days of pregnancy

Phase 1

Completed

• Conditions: Induced abortion; Pregnancy and Childbirth

• Registration Number: ISRCTN35625202
• Lead Sponsor: Gynuity Health Projects

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-16
• Study Completion: 2023-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 166

Inclusion Criteria

1. Pregnant with estimated gestational age =63 days by ultrasound and desiring an abortion
2. Body mass index (BMI) =32 kg/m²
3. Aged =18 years old or emancipated minor
4. With access to a telephone for follow-up communication
5. Resident of Mexico City
6. Able to provide informed consent

Exclusion Criteria

1. History of hepatic or renal disease
2. Confirmation or suspicion of ectopic pregnancy, gestational trophoblastic disease or undiagnosed adnexal mass
3. IUD in place
4. History of allergy to ulipristal or misoprostol (or other prostaglandins)
5. Unwilling to or with significant difficulty preventing return to clinic for follow up
6. Unable to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events (complications) measured using self-reporting at any point prior to discharge from the study