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Mifepristone-misoprostol vs. Misoprostol Alone for Second Trimester Fetal Death

NCT02633761 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-02-11

No results posted yet for this study

Summary

The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP.

Conditions

  • Fetal Death

Interventions

DRUG

Mifepristone

200mg mifepristone followed in 24 hours by 200mcg buccal misoprostol every 3 hours.

DRUG

Placebo

placebo followed in 24 hours by 200mcg buccal misoprostol every 3 hours.

DRUG

Misoprostol 200mcg

Buccal misoprostol 200mcg

Sponsors & Collaborators

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Hillary Bracken, PhD · Gynuity Health Projects

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-01
Primary Completion
2018-12-30
Completion
2018-12-30

Countries

  • Mexico
  • Vietnam

Study Locations

More Related Trials

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 NCT02633761 on ClinicalTrials.gov