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

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 Overview

• Status: Completed
• Conditions: Intrauterine Fetal Demise
• Intervention / Treatment: Drug: Misoprostol; Drug: Misoprostol

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health System
  • Illinois
    • Chicago, Illinois, United States, 60622
      • University of Illinois at Chicago
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine
• Vietnam
  • Ho Chi Minh City, Vietnam
    • Huong Vuong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Successful Expulsion of Fetus and Placenta Within 48 Hours	48 hours

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: April 29, 2008
• First Submitted That Met QC Criteria: April 29, 2008
• First Posted (Estimate): May 2, 2008

Study Record Updates

• Last Update Posted (Estimate): May 8, 2013
• Last Update Submitted That Met QC Criteria: May 6, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: misoprostol; intrauterine fetal death
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Fetal Death; Stillbirth; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 3.3; 1R01FD003107-01A1 (U.S. FDA Grant/Contract)