Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy
Information source: Gynuity Health Projects
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fetal Death
Intervention: Misoprostol (Drug); Misoprostol (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Gynuity Health Projects Official(s) and/or principal investigator(s):
Beverly Winikoff, MD, MPH, Principal Investigator, Affiliation: Gynuity Health Projects
Overall contact:
Hillary J Bracken, PhD, MHS, Phone: 212.448.1230, Email: hbracken@gynuity.org
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Successful expulsion of fetus within 48 hours
Secondary outcome: Need for surgical/other intervention to deliver fetus
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Hillary J Bracken, PhD, MHS, Phone: 212.448.1230, Email: hbracken@gynuity.org
Huong Vuong Hospital, Ho Chi Minh City, Vietnam; Recruiting
Nguyen thi Nhu Ngoc, MD, MPH, Phone: 84 8 38586296, Email: nhungoccrcrh@gmail.com
Nguyen thi Nhu Ngoc, MD, MPH, Principal Investigator
Stanford University, Palo Alto, California 94305, United States; Recruiting
Paul Blumenthal, MD, Email: pblumen@stanford.edu
Paul Blumenthal, MD, Principal Investigator
Christiana Care Health System, Newark, Delaware 19718, United States; Recruiting
Richard Derman, MD, MPH, Phone: 302-733-2958, Email: RDerman@christianacare.org
Katie Brennecke, RN, BSN, Phone: 302-733-2958, Email: krbrennecke@christianacare.org
Richard Derman, MD, MPH, Principal Investigator
University of Florida Health Science Center-Jacksonville, Jacksonville, Florida 32209-6561, United States; Withdrawn
University of Illinois at Chicago, Chicago, Illinois 60622, United States; Recruiting
Ashlesha Patel, MD, Phone: 312-864-5935
Ashlesha Patel, MD, Principal Investigator
Harvard Medical School/Brigham & Women's Hospital, Boston, Massachusetts 02115, United States; Withdrawn
Boston Medical Center, Boston, Massachusetts 02118, United States; Withdrawn
Albert Einstein College of Medicine, Bronx, New York 10461, United States; Recruiting
Erika Banks, MD, Email: ebanks@montefiore.org
Erika Banks, MD, Principal Investigator
Marji Gold, MD, Principal Investigator
Additional Information
Starting date: October 2008
Last updated: March 14, 2011
|
