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

This study has been completed.
Sponsor:
Collaborators:
Stanford University
Albert Einstein College of Medicine of Yeshiva University
University of Florida
Huong Vuong Hospital
Boston Medical Center
Christiana Care Health Services
University of Illinois at Chicago
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00671060
First received: April 29, 2008
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Intrauterine Fetal Demise
Drug: Misoprostol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Successful Expulsion of Fetus and Placenta Within 48 Hours [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Enrollment: 153
Study Start Date: October 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
100 mcg buccal misoprostol administered every 6 hours for upto 48 hours

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671060

Locations
United States, California
Stanford University
Palo Alto, California, United States, 94305
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19718
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60622
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Vietnam
Huong Vuong Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Gynuity Health Projects
Stanford University
Albert Einstein College of Medicine of Yeshiva University
University of Florida
Huong Vuong Hospital
Boston Medical Center
Christiana Care Health Services
University of Illinois at Chicago
Investigators
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
  More Information

Additional Information:
No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00671060     History of Changes
Other Study ID Numbers: 3.3, 1R01FD003107-01A1
Study First Received: April 29, 2008
Results First Received: February 13, 2013
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gynuity Health Projects:
intrauterine fetal death
misoprostol

Additional relevant MeSH terms:
Misoprostol
Fetal Death
Pregnancy Complications
Death
Pathologic Processes
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on August 28, 2014