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

NCT00671060 | Completed Phase 3 Results DMC

• 2 other identifiers: 3.31R01FD003107-01A1
• Study Type: interventional
• Target: 153
• Locations: 2 countries
• Sites: 5

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.

Conditions

Intrauterine Fetal Demise

Keywords

intrauterine fetal death; misoprostol

Outcome Measures

Primary Outcomes (1)

• Successful Expulsion of Fetus and Placenta Within 48 Hours

  48 hours

Study Arms (2)

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

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

Interventions

Misoprostol DRUG

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

2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women presents with spontaneous fetal death
• Gestational age of fetus between 14-28 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Gynuity Health Projects: lead
• Stanford University: collaborator
• Albert Einstein College of Medicine: collaborator
• University of Florida: collaborator
• Huong Vuong Hospital: collaborator
• Boston Medical Center: collaborator
• Christiana Care Health Services: collaborator
• University of Illinois at Chicago: collaborator

Study Sites (5)

Stanford University

Palo Alto, California, 94305, United States

Location

Christiana Care Health System

Newark, Delaware, 19718, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60622, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Huong Vuong Hospital

Ho Chi Minh City, Vietnam

Location

Related Links

• Related Info

MeSH Terms

Conditions

Stillbirth

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Hillary Bracken
• Organization: Gynuity Health Projects

hbracken@gynuity.org

2124481230

Study Officials

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 2, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 8, 2013
• Results First Posted: May 6, 2013

Record last verified: 2013-05

Locations

VN (1); US (4)