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Mifepristone and Misoprostol for Fetal Demise

NCT00177372 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-01-29

No results posted yet for this study

Summary

This is a pilot clinical trial to evaluate whether the medical management of early pregnancy failure with mifepristone and misoprostol is an effective and acceptable treatment. Subjects with early pregnancy failure receive mifepristone followed 24 hours later by vaginal misoprostol for medical management. Subjects then return on study day 3 for a repeat ultrasound to assess passage of pregnancy tissue. subjects who still have a gestational sac present at Day 3 receive a second dose of vaginal misoprostol. All subjects have a follow-up at Day 15, by phone for those who passed the pregnancy with the first dose of misoprostol, and in person for those who received a second dose. Questionnaires are administered at the beginning and end of the study to determine acceptability.

Conditions

  • Anembryonic Pregnancy
  • Gestation Abnormality
  • Intrauterine Fetal Demise Term

Interventions

DRUG

mifepristone/misoprostol

mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Mitchell D Creinin, MD · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2005-09-30
Completion
2005-09-30

Countries

  • United States

Study Locations

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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 NCT00177372 on ClinicalTrials.gov