Mifepristone and Misoprostol for Fetal Demise

Phase 4

Completed

• Conditions: Gestation Abnormality; Anembryonic Pregnancy; Intrauterine Fetal Demise Term
• Interventions: Drug: mifepristone/misoprostol

• Registration Number: NCT00177372
• Lead Sponsor: University of Pittsburgh

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-28
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

healthy hemodynamically stable females with a non-viable pregnancy

Exclusion Criteria

• orthostatic hypotension, contraindication to either mifepristone or misoprostol, treatment during current pregnancy to provide surgical or medical evacuation of the uterus, evidence of ovarian hyperstimulation syndrome, known or suspected pelvic infection,known or suspected clotting defect or receiving anticoagulants, cardiovascular disease, current breastfeeding, pregnancy with and IUD in situ, current participation in another clinical trial, prior participation in this trial, suspected or confirmed endometrial AV malformation, clinical indication requiring the karyotyping of products of conception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	mifepristone/misoprostol	Mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally

Primary Outcome Measures

Name	Time	Method
to determine if medical management with mifepristone and misoprostol for early pregnancy failure is an effective and acceptable treatment	1-2 weeks

Secondary Outcome Measures

Name	Time	Method
to evaluate if the treatment of early pregnancy failure with mifepristone and misoprostol is as effective as induced abortion with these medications	1-2 weeks
to assess if mifepristone/misoprostol treatment is acceptable to patients with early pregnancy failure	1-2 weeks
to assess the predictors/indicators for successful mifpristone/misoprostol treatment in patients with early pregnancy failure	1-2 weeks

Trial Locations

Locations (1)

Magee-Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States