Clinical Trial: Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy, Inclusive, Not Accompanied by Complete Expulsion of the Contents of the Uterus
Brief Summary: The purpose of the proposed study is to test - in a randomized, blinded trial - two different doses of the prostaglandin E1 analogue misoprostol administered buccally as a treatment for fetal death at 14 - 28 weeks, inclusive, of pregnancy. At such an advanced stage of pregnancy, the nonviable fetus is often not spontaneously evacuated, and yet timely evacuation is vital in order to avoid the possibility of, among other things, potentially life-threatening maternal coagulopathies. Current approaches to uterine evacuation in these cases include dilatation and evacuation (D&E) surgery (in less advanced pregnancies) and labor induction with a variety of products. Misoprostol has been demonstrated to be as effective as, or more effective than, either oxytocin or prostaglandin E2 analogues for this indication in a number of small, non-FDA-approved trials which have been published in the peer-reviewed literature. In the absence of more formal study of this treatment, however, dosages are not standardized, pathways of administration vary, and other uncertainties linger. The purpose of the protocol proposed herein is to formally establish, via a randomized, double-blinded study, the safety and effectiveness of misoprostol for this indication, and to compare the value of two distinct doses, so that providers may henceforward proceed with greater authority and confidence.
Detailed Summary:
Sponsor: Gynuity Health Projects
Current Primary Outcome: Successful Expulsion of Fetus and Placenta Within 48 Hours [ Time Frame: 48 hours ]
Original Primary Outcome: Successful expulsion of fetus within 48 hours [ Time Frame: 48 ]
Current Secondary Outcome:
Original Secondary Outcome: Need for surgical/other intervention to deliver fetus [ Time Frame: 48 hours ]
Information By: Gynuity Health Projects
Dates:
Date Received: April 29, 2008
Date Started: October 2008
Date Completion:
Last Updated: May 6, 2013
Last Verified: May 2013
