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Sponsors and Collaborators: |
Gynuity Health Projects Stanford University Albert Einstein College of Medicine of Yeshiva University University of Florida Harvard University Boston Medical Center University of Illinois |
Information provided by: | Gynuity Health Projects |
ClinicalTrials.gov Identifier: | NCT00671060 |
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 Death |
Drug: Misoprostol |
Phase III |
ChemIDplus related topics: | Misoprostol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 146 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
2: Active Comparator
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.
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Drug: Misoprostol
200 mcg buccal misoprostol administered every 6 hours for up to 48 hours until fetus is delivered.
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1: Placebo Comparator
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.
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Drug: Misoprostol
100 mcg buccal misoprostol administered every 6 hours for upto 48 hours
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hillary J Bracken, PhD, MHS | 212.448.1230 | hbracken@gynuity.org |
United States, California | |||||
Stanford University | Recruiting | ||||
Palo Alto, California, United States, 94305 | |||||
Contact: Paul Blumenthal, MD pblumen@stanford.edu | |||||
Principal Investigator: Paul Blumenthal, MD | |||||
United States, Florida | |||||
University of Florida Health Science Center-Jacksonville | Not yet recruiting | ||||
Jacksonville, Florida, United States, 32209-6561 | |||||
Contact: Luis Sanchez-Ramos, MD luis.sanchez@jax.ufl.edu | |||||
Principal Investigator: Luis Sanchez-Ramos, MD | |||||
United States, Illinois | |||||
University of Illinois at Chicago | Not yet recruiting | ||||
Chicago, Illinois, United States, 60622 | |||||
Contact: Ashlesha Patel, MD 312-864-5935 | |||||
Principal Investigator: Ashlesha Patel, MD | |||||
United States, Massachusetts | |||||
Harvard Medical School/Brigham & Women's Hospital | Not yet recruiting | ||||
Boston, Massachusetts, United States, 02115 | |||||
Contact: Daniela Carusi, MD, MSc DCARUSI@PARTNERS.ORG | |||||
Principal Investigator: Daniela Carusi, MD,MSc | |||||
Boston Medical Center | Recruiting | ||||
Boston, Massachusetts, United States, 02118 | |||||
Contact: Lynn Borgotta, MD, MPH 617-414-3440 | |||||
Principal Investigator: Lynn Borgotta, MD,MPH | |||||
United States, New York | |||||
Albert Einstein College of Medicine | Recruiting | ||||
Bronx, New York, United States, 10461 | |||||
Contact: Erika Banks, MD ebanks@montefiore.org | |||||
Principal Investigator: Erika Banks, MD | |||||
Principal Investigator: Marji Gold, MD |
Gynuity Health Projects |
Stanford University |
Albert Einstein College of Medicine of Yeshiva University |
University of Florida |
Harvard University |
Boston Medical Center |
University of Illinois |
Principal Investigator: | Beverly Winikoff, MD, MPH | Gynuity Health Projects |
Related Info 
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Responsible Party: | Gynuity Health Projects ( Dr. Beverly Winikoff ) |
Study ID Numbers: | 3.3, 1R01FD003107-01A1 |
First Received: | April 29, 2008 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00671060 |
Health Authority: | United States: Food and Drug Administration |
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