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

Adverse events, acceptability and efficacy of a combined regimen of ulipristal acetate and misoprostol for abortion through 63 days of gestation

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN35625202

Enrollment

166

Registered

2022-08-16

Start date

2022-08-31

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induced abortion Pregnancy and Childbirth

Interventions

Phase 1 of the research will compare two medication regimens with ulipristal acetate and misoprostol: 60 mg UPA orally + 800 mcg misoprostol buccally versus 90 mg UPA orally + 800 mcg misoprostol bucc

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Current secondary outcome measures as of 06/08/2024: 1. Side effects measured using self-reporting 1 hour after ulipristal administration and at the scheduled follow-up visit 7-10 later 2. Efficacy measured using a clinical assessment and ultrasound findings of abortion outcome at the scheduled follow-up visit 7-10 days later 3. Acceptability to participants of study medication measured using self-reporting at discharge from the study 4. Pain measured using a scale from 0-10 one hour after ulipristal administration and at the scheduled follow-up visit 7-10 days later Previous secondary outcome measures: 1. Side effects measured using self-reporting 1 hour after ulipristal administration and at the 1-week follow-up visit 2. Efficacy measured using a clinical assessment of pregnancy viability at the 1-week follow-up 3. Acceptability to participants of study medication measured using self-reporting at discharge from the study 4. Pain measured using a scale from 0-10 one hour after ulipristal administration and at the 1-week follow-up visit	—

Measure

Time frame

Current secondary outcome measures as of 06/08/2024: 1. Side effects measured using self-reporting 1 hour after ulipristal administration and at the scheduled follow-up visit 7-10 later 2. Efficacy measured using a clinical assessment and ultrasound findings of abortion outcome at the scheduled follow-up visit 7-10 days later 3. Acceptability to participants of study medication measured using self-reporting at discharge from the study 4. Pain measured using a scale from 0-10 one hour after ulipristal administration and at the scheduled follow-up visit 7-10 days later Previous secondary outcome measures: 1. Side effects measured using self-reporting 1 hour after ulipristal administration and at the 1-week follow-up visit 2. Efficacy measured using a clinical assessment of pregnancy viability at the 1-week follow-up 3. Acceptability to participants of study medication measured using self-reporting at discharge from the study 4. Pain measured using a scale from 0-10 one hour after ulipristal administration and at the 1-week follow-up visit

—

Countries

Mexico

Contacts

Public ContactIlana Dzuba

idzuba@gynuity.org+1 212 448 1230

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026