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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Early Pregnancy Loss
• Intervention / Treatment: Drug: 200mg mifepristone and 800mg misoprostol

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.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Courtney Schreiber; Phone Number: 267-785-8044; Email: peaceresearch@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mifepristone and Misoprostol; 200mg oral mifepristone and 800mg vaginal misoprostol	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Number of serious adverse events related to study procedures, particularly hemorrhage resulting in blood transfusion and pelvic infection, as collected from chart review and participant self-report.	42 days
Treatment acceptability	Participants' overall assessment of the treatment measured on a 3-point scale.	42 days
Treatment satisfaction	Participants' overall assessment of the treatment measured on a 3-point scale.	42 days

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: miscarriage; early pregnancy loss
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Abortion, Spontaneous; Fatty Acids; Lipids; Biological Factors; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Estrenes; Estranes; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Prostaglandins E, Synthetic; Misoprostol; Mifepristone
• Other Study ID Numbers: 26-0107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No