NCT00177372

Mifepristone and Misoprostol for Fetal Demise

Mifepristone and Misoprostol for the Treatment of Early Pregnancy Failure: a Pilot Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	mifepristone/misoprostol	mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally

Timeline

• Start date: 2005-01-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2005-09-15
• Last updated: 2016-01-29

Locations

1 site across 1 country: United States