Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy

Completed · Phase 3

Conditions studied: Intrauterine Fetal Demise

In brief

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.

Key facts

Study ID

NCT00671060

Run by

Gynuity Health Projects

People needed

153

Starts

2008-10-01

Expected to finish

2011-12-01

Last updated by the study team

2013-05-08

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women presents with spontaneous fetal death
• Gestational age of fetus between 14-28 weeks

You may not qualify if…

• Transmural uterine scar;
• Allergies or other contraindications to use of misoprostol;
• Placental abruption with active hemorrhage;
• Complete placenta previa;
• Extreme uterine structural anomalies;
• Or other contraindications to vaginal delivery of the fetus;
• Presentation in active labor (moderate to severe contractions every 10 minutes); or
• Four or more previous deliveries

Where it is running

• Stanford University — Palo Alto, California, United States
• Christiana Care Health System — Newark, Delaware, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Albert Einstein College of Medicine — The Bronx, New York, United States
• Huong Vuong Hospital — Ho Chi Minh City, Vietnam

Full record on ClinicalTrials.gov

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