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

NCT07506512 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 26-0107
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Early Pregnancy Loss

Keywords

early pregnancy loss; miscarriage

Outcome Measures

Primary Outcomes (1)

• Treatment success

  Gestational sac expulsion by first follow-up visit (as indicated by transvaginal ultrasound), with one dose of misoprostol and no additional need for medical/surgical intervention; comparison of this outcome between patient chosen intervals.

  17 days

Secondary Outcomes (3)

• Adverse Events

  42 days

• Treatment acceptability

  42 days

• Treatment satisfaction

  42 days

Study Arms (1)

Mifepristone and Misoprostol

EXPERIMENTAL

200mg oral mifepristone and 800mg vaginal misoprostol

Drug: 200mg mifepristone and 800mg misoprostol

Interventions

200mg mifepristone and 800mg misoprostol DRUG

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

Mifepristone and Misoprostol

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to participate in the informed consent process and provide a signed and dated consent form.
• Stated willingness to comply with all study procedures.
• Access to device with text or email capability.
• Able to read and understand English.
• Confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation (ultrasound examination demonstrates a fetal pole without cardiac activity measuring between 5.3 and 40mm or an abnormal growth pattern diagnostic of early pregnancy loss.

You may not qualify if:

• Incomplete or inevitable abortion.
• Contraindication or allergy to mifepristone or misoprostol
• Unable to return for clinic-based follow-up.

Sponsors & Collaborators

• University of Pennsylvania: lead

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Mifepristone; Misoprostol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Courtney Schreiber

CONTACT

267-785-8044; peaceresearch@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share