Clinical Trial: Mifepristone and Misoprostol for Fetal Demise
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Mifepristone and Misoprostol for the Treatment of Early Pregnancy Failure: a Pilot Clinical Trial
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 Summary:
Sponsor: University of Pittsburgh
Current Primary Outcome: to determine if medical management with mifepristone and misoprostol for early pregnancy failure is an effective and acceptable treatment [ Time Frame: 1-2 weeks ]
Original Primary Outcome: to determine if medical management with mifepristone and misoprostol for early pregnancy failure is an effective and acceptable treatment
Current Secondary Outcome:
- to evaluate if the treatment of early pregnancy failure with mifepristone and misoprostol is as effective as induced abortion with these medications [ Time Frame: 1-2 weeks ]
- to assess if mifepristone/misoprostol treatment is acceptable to patients with early pregnancy failure [ Time Frame: 1-2 weeks ]
- to assess the predictors/indicators for successful mifpristone/misoprostol treatment in patients with early pregnancy failure [ Time Frame: 1-2 weeks ]
Original Secondary Outcome:
- to evaluate if the treatment of early pregnancy failure with mifepristone and misoprostol is as effective as induced abortion with these medications
- to assess if mifepristone/misoprostol treatment is acceptable to patients with early pregnancy failure
- to assess the predictors/indicators for successful mifpristone/misoprostol treatment in patients with early pregnancy failure
Information By: University of Pittsburgh
Dates:
Date Received: September 12, 2005
Date Started: January 2005
Date Completion:
Last Updated: January 28, 2016
Last Verified: January 2016
