NCT07506512

Optimal Time Interval Between Mifepristone and Misoprostol Administration for Early Pregnancy Loss

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

A prospective cohort study to explore the optimal time interval between mifepristone and misoprostol administration for medical management of early pregnancy loss. Participants will be followed to assess treatment success, satisfaction, and side effects.

Detailed description

This is a prospective trial to establish the optimal time interval between mifepristone and misoprostol administration for the management of early pregnancy loss. Participants will be followed to assess treatment success, side effects, and satisfaction with the misoprostol interval. Patients will be invited to participate if they are clinically eligible for medical management of early pregnancy loss. After consent is obtained, eligibility will be confirmed by a designated study investigator. Participants will take 200mg of mifepristone by mouth and will be instructed to administer misoprostol any time between 4- and 24-hours post-mifepristone. They will receive instructions for vaginal misoprostol administration. Participants will be prompted to report the time of medication administration via text, email, or portal message. Participants will follow up as clinically indicated. At the clinical follow-up visit, participants will complete a brief survey to collect preliminary adverse event information, and then the study staff will review adverse events and concomitant medications with participants. Study staff will remind participants when they took mifepristone and misoprostol and ask participants what influenced their decision to administer misoprostol at their chosen time. Study staff will follow up 42 days after study enrollment to review adverse events and concomitant medications and to administer a satisfaction and acceptability survey. Medical records will also be reviewed for any additional clinical intervention or adverse event since enrollment. Clinicians performing the follow-up transvaginal ultrasound will be blinded to the participant's misoprostol administration timing.

Conditions

• Early Pregnancy Loss

Interventions

Type	Name	Description
DRUG	200mg mifepristone and 800mg misoprostol	Participants will take 200mg of mifepristone by mouth and will be instructed to administer misoprostol any time between 4- and 24-hours post-mifepristone.

Timeline

• Start date: 2026-07-01
• Primary completion: 2031-07-01
• Completion: 2031-12-01
• First posted: 2026-04-01
• Last updated: 2026-04-01

Regulatory

• FDA-regulated drug study