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

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.

Conditions

• Intrauterine Fetal Demise

Interventions

DRUG

Misoprostol

200 mcg buccal misoprostol administered every 6 hours for up to 48 hours until fetus is delivered.

DRUG

Misoprostol

100 mcg buccal misoprostol administered every 6 hours for upto 48 hours

Sponsors & Collaborators

• Stanford University

  collaborator OTHER

• Albert Einstein College of Medicine

  collaborator OTHER

• University of Florida

  collaborator OTHER

• Huong Vuong Hospital

  collaborator UNKNOWN

• Boston Medical Center

  collaborator OTHER

• Christiana Care Health Services

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• Gynuity Health Projects

  lead OTHER

Principal Investigators

• Beverly Winikoff, MD, MPH · Gynuity Health Projects

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-10-31

Primary Completion

2011-12-31

Completion

2011-12-31

Countries

• United States
• Vietnam

Study Locations