Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester Pregnancy: a Pilot Randomized Controlled Trial

NCT05322252 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 202202144
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

When time allows, administration of mifepristone prior to second trimester induction of labor decreases total labor time. However, in the setting of many pregnancy complications, decreasing time from diagnosis of nonviable pregnancy to delivery is of utmost importance to decrease risk of maternal complications. Previous data has shown that total abortion time is longer in the group receiving mifepristone owing to the delay between mifepristone administration and initiation of misoprostol induction of labor. Thus, the investigators aim to investigate whether simultaneous mifepristone and misoprostol has benefits over misoprostol alone when labor induction of a nonviable second trimester cannot be delayed.

Conditions

PPROM; Rupture, Spontaneous; Fetal Demise; Fetal Death; Fetal Demise From Miscarriage; Fetal Death Before 22 Weeks With Retention of Dead Fetus; Pregnancy Loss; Pregnancy Complications; Abortion, Second Trimester

Outcome Measures

Primary Outcomes (1)

• Delivery Within 12 Hours

  Delivery of fetus and placenta

  12 hours

Secondary Outcomes (6)

• Delivery Within 24 Hours

  24 hours

• Time to Delivery

  During admission

• Failed Induction of Labor

  During admission

• Retained Placenta

  During admission

• Diagnosis of Clinical Chorioamnionitis

  During admission

Other Outcomes (1)

• Pregnancy Related Readmission Within 30 Days

  30 days

Study Arms (2)

Simulatenous mifepristone and misoprostol

EXPERIMENTAL

Participants will receive a dose of 200mg oral mifepristone at time of induction with misoprostol

Drug: Mifepristone; Drug: Misoprostol

Misoprostol alone

ACTIVE COMPARATOR

Participants will have labor induced with misoprostol alone

Drug: Misoprostol

Interventions

Mifepristone DRUG

200mg orally

Simulatenous mifepristone and misoprostol

Misoprostol DRUG

Per clinician

Misoprostol alone; Simulatenous mifepristone and misoprostol

Eligibility Criteria

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

You may qualify if:

• years or older
• and 28 weeks' gestation
• Singleton gestation
• Nonviable fetus (i.e. fetal demise or previable gestational age/weight or lethal fetal anomaly)
• Requires induction of labor
• If fetal cardiac motion, abortion being performed for medical emergency per MO laws and consents completed

You may not qualify if:

• Contraindication to mifepristone
• Plan for surgical evacuation of uterus
• Contraindication to vaginal delivery
• Plan to initiate induction with any medication or device except misoprostol
• Declines participation

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes; Rupture, Spontaneous; Fetal Death; Pregnancy Complications

Interventions

Mifepristone; Misoprostol

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes

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

Results Point of Contact

• Title: Katherine Bligard
• Organization: Washington University School of Medicine

khsmith@wustl.edu

2259542160

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal-Fetal Medicine Fellow

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 11, 2022
• Study Start: July 1, 2022
• Primary Completion: June 14, 2025
• Study Completion: July 14, 2025
• Last Updated: March 18, 2026
• Results First Posted: March 18, 2026

Record last verified: 2026-02

Locations

US (1)