Clinical trial NCT00671060: Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intrauterine Fetal Demise
Keywords: intrauterine fetal death
misoprostol
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Albert Einstein College of Medicine
name: University of Florida
name: Huong Vuong Hospital
name: Boston Medical Center
name: Christiana Care Health Services
name: University of Illinois at Chicago
First posted: 2008-05-02
Enrollment: 153
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
measure: Successful Expulsion of Fetus and Placenta Within 48 Hours
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Ho Chi Minh City
country: Vietnam
facility: Huong Vuong Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: