Buccal misoprostol for treatment of fetal death at 14-28 weeks of pregnancy: a double-blind randomized controlled trial.

Abstract

OBJECTIVE:

To assess whether buccal misoprostol is effective for the treatment of intrauterine fetal death.

STUDY DESIGN:

This double-blind randomized trial was conducted at five tertiary-level hospitals in the United States and Vietnam. One hundred fifty-three women with an intrauterine fetal death at 14-28 weeks of pregnancy received either 100 mcg buccal misoprostol or 200 mcg buccal misoprostol every 6 h for a maximum of 8 doses. The main outcome measure was the fetal-placental delivery rate within 48 hours of prostaglandin commencement without any additional intervention.

RESULTS:

Most of the women (140/153) were recruited at the study site in Vietnam. Expulsion of both fetus and placenta within 48 hours of prostaglandin commencement without any additional interventions occurred in 61.8% (47/76) of women receiving misoprostol 100 mcg and 77.9% (60/77) of women receiving misoprostol 200 mcg. The 200 mcg dose was significantly more effective than the 100 mcg dose at expelling the fetus and placenta within 48 h [RR 0.68 (95% CI: 0.50-0.92; p=.03)]. The mean time to expulsion was significantly shorter using the 200 mcg dose (18.5±11.9 h) than the 100 mcg dose (23.9±12.5 h) (p=.02). Most women in both groups found the procedure satisfactory or very satisfactory (100 mcg: 76.7% (56/73); 200 mcg: 89.5% (68/76) [RR 0.86 (95% CI: 0.74-1.00)].

CONCLUSION:

Buccal misoprostol is an effective method for medical induction of labor after intrauterine fetal demise. A 200 mcg dose is significantly more effective than 100 mcg for evacuating the uterus within 48h. The treatment is highly acceptable to women.

IMPLICATIONS:

Administration of 200 mcg buccal misoprostol every six hours is an effective and acceptable method to effect the delivery of a demised fetus at 14-28 weeks that can be feasibly implemented in a wide variety of settings.

• Authors: Hillary Bracken, Nguyen Thi Nhu Ngoc, Erika Banks, Paul D Blumenthal, Richard J Derman, Ashlesha Patel, Marji Gold, Beverly Winikoff, Buccal misoprostol for IUFD Research Group
• Journal: Contraception (Contraception) Vol. 89 Issue 3 Pg. 187-92 (Mar 2014) ISSN: 1879-0518 [Electronic] United States
• PMID: 24405797 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, Non-P.H.S.)
• Copyright: Copyright © 2014 Elsevier Inc. All rights reserved.

Chemical References

• Abortifacient Agents, Nonsteroidal
• Misoprostol
• Oxytocin

Topics

• Abortifacient Agents, Nonsteroidal (administration & dosage)
• Administration, Buccal
• Adult
• Delivery, Obstetric
• Double-Blind Method
• Female
• Fetal Death (therapy)
• Gestational Age
• Humans
• Labor, Induced (methods)
• Misoprostol (administration & dosage, adverse effects)
• Oxytocin (administration & dosage)
• Pregnancy
• Treatment Outcome
• United States
• Vietnam