drugset / Trial / NCT00177372

Mifepristone and Misoprostol for Fetal Demise

NCT00177372

Phase 4 Completed 30 enrolled University of Pittsburgh
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2005-01
Primary completion
2005-09
Completion
2005-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Mifepristone Small molecule 200 mg Oral
Subject Misoprostol Other / unclassified 800 ug Intravenous