Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy

Intrauterine Fetal Demise Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00671060
• Other study ID #: 3.3
• Secondary ID: 1R01FD003107-01A
• Status: Completed
• Phase: Phase 3
• First received: April 29, 2008
• Last updated: May 6, 2013
• Start date: October 2008
• Est. completion date: December 2011

Study information

• Verified date: May 2013
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Death
• Intrauterine Fetal Demise

Intervention

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

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Christiana Care Health System	Newark	Delaware
United States	Stanford University	Palo Alto	California
Vietnam	Huong Vuong Hospital	Ho Chi Minh City

Sponsors (8)

Lead Sponsor	Collaborator
Gynuity Health Projects	Albert Einstein College of Medicine of Yeshiva University, Boston Medical Center, Christiana Care Health Services, Huong Vuong Hospital, Stanford University, University of Florida, University of Illinois at Chicago

Countries where clinical trial is conducted

United States,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful Expulsion of Fetus and Placenta Within 48 Hours		48 hours	Yes

External Links

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