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

Gynuity Health Projects

Status and phase: Completed; Phase 3

Conditions: Intrauterine Fetal Demise

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00671060

1R01FD003107-01A1

3.3

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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153 participants in 2 patient groups, including a placebo group

2

Active Comparator group

Description:

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.

Treatment:

Drug: Misoprostol

Drug: Misoprostol

1

Placebo Comparator group

Description:

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.

Treatment:

Drug: Misoprostol

Drug: Misoprostol