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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynuity Health Projects
• Collaborators: Albert Einstein College of Medicine; Albert Einstein College of Medicine of Yeshiva University; Boston Medical Center; Christiana Care Health Services; Huong Vuong Hospital; Stanford University; University of Florida; University of Illinois at Chicago
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

• Women presents with spontaneous fetal death

• Gestational age of fetus between 14-28 weeks

Exclusion Criteria:

• 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