Status:
COMPLETED
Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy
Lead Sponsor:
Gynuity Health Projects
Collaborating Sponsors:
Stanford University
Albert Einstein College of Medicine
Conditions:
Intrauterine Fetal Demise
Eligibility:
FEMALE
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Women presents with spontaneous fetal death
- Gestational age of fetus between 14-28 weeks
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00671060
Start Date
October 1 2008
End Date
December 1 2011
Last Update
May 8 2013
Active Locations (5)
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1
Stanford University
Palo Alto, California, United States, 94305
2
Christiana Care Health System
Newark, Delaware, United States, 19718
3
University of Illinois at Chicago
Chicago, Illinois, United States, 60622
4
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461