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

NCT05322252 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-07

Study results available
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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

  • Abortion, Second Trimester
  • 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

Interventions

DRUG

Mifepristone

200mg orally

DRUG

Misoprostol

Per clinician

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2025-06-14
Completion
2025-07-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05322252 on ClinicalTrials.gov