Buccal misoprostol for treatment of fetal death at 14-28 weeks of pregnancy: a double-blind randomized controlled trial.
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.
['Bracken|Hillary|H|', 'Ngoc|Nguyen Thi Nhu|NT|', 'Banks|Erika|E|', 'Blumenthal|Paul D|PD|', 'Derman|Richard J|RJ|', 'Patel|Ashlesha|A|', 'Gold|Marji|M|', 'Winikoff|Beverly|B|', '|||']
D000020:Abortifacient Agents, Nonsteroidal D000278:Administration, Buccal D000328:Adult D036861:Delivery, Obstetric D004311:Double-Blind Method D005260:Female D005313:Fetal Death D005865:Gestational Age D006801:Humans D007751:Labor, Induced D016595:Misoprostol D010121:Oxytocin D011247:Pregnancy D016896:Treatment Outcome D014481:United States D014744:Vietnam
Buccal misoprostol Intrauterine fetal demise