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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2010

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 2
  • Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
• Placebo Comparator: 1
  • Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.

Primary Measures

• Successful expulsion of fetus within 48 hours
  • Time Frame: 48
    Safety Issue?: Yes

Secondary Measures

• Need for surgical/other intervention to deliver fetus
  • Time Frame: 48 hours
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Gynuity Health Projects

Overall Clinical Trial Officials and Contacts

Beverly Winikoff, MD, MPH Principal Investigator Gynuity Health Projects  

Overall Contact: Hillary J Bracken, PhD, MHS 212.448.1230 hbracken@gynuity.org

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00671060

Study ID Number: 3.3

ClinicalTrials.gov Identifier: NCT00671060

Health Authority: United States: Food and Drug Administration