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Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy, Inclusive, Not Accompanied by Complete Expulsion of the Contents of the Uterus

This study is currently recruiting participants.
Verified by Gynuity Health Projects, October 2008

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
  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 Death
Drug: Misoprostol
Phase III

ChemIDplus related topics:   Misoprostol   

U.S. FDA Resources

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

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Successful expulsion of fetus within 48 hours [ Time Frame: 48 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Need for surgical/other intervention to deliver fetus [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

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.
Drug: Misoprostol
200 mcg buccal misoprostol administered every 6 hours for up to 48 hours until fetus is delivered.
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.
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

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

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

Locations
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            

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

Investigators
Principal Investigator:     Beverly Winikoff, MD, MPH     Gynuity Health Projects    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

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

Keywords provided by Gynuity Health Projects:
intrauterine fetal death  
misoprostol  

Study placed in the following topic categories:
Death
Pregnancy Complications
Misoprostol
Fetal Death

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

ClinicalTrials.gov processed this record on October 10, 2008




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