To systematically assess whether misoprostol has high safety and effectiveness for the treatment of intrauterine fetal death at 14-28 weeks of pregnancy and to help establish the best dose of misoprostol for this purpose.
This double-blind trial randomized 153 women, 14-28 weeks gestation, into two groups. Women received either 100mcg buccal misoprostol (Group 1) or 200 mcg buccal misoprostol (Group 2) every 6h for a maximum of 8 doses. The primary outcome was successful evacuation within 48h.
The 200mcg dose was significantly more effective than the 100 mcg dose at evacuating the uterus within 48h (Group 1: 66.7%; Group 2: 84.2% (RR 0.79 (95%CI: 0.65-0.95). The mean time to evacuation was significantly shorter in Group 2 (18.9h +11.9h) than Group 1 (24.0 +12.4h) (p=0.03). The side effect profile was similar in the two groups. Few women reported nausea (Group 1: 19%; Group 2: 24%), vomiting (Group 1: 10%; Group 2: 16%), chills (Group 1: 24%; Group 2:21%) or headache (Group 1: 16%; Group 2: 21%). However, significantly more women in the 200mcg group reported diarrhea (Group 1: 10%; Group 2: 33%; p-value: 0.05). Most women in both groups found the side effects either acceptable or highly acceptable (Group 1: 74.8%; Group 2: 89.5%). Most women in both groups found the procedure satisfactory or very satisfactory (Group 1: 74.3%; Group 2: 88.1%). However, significantly more women in Group 1 cited that the length of hospitalization was the worst aspect of the procedure (Group 1: 18.9%; Group 2: 7.9%; p-value=0.05).
Misoprostol is a safe and effective method for medical induction of labor after intrauterine fetal demise. A 200mcg dose is significantly more effective than 100mcg for evacuating the uterus within 48h. The side effects and treatment are highly acceptable to women.
© 2013 Mosby, Inc. Published by Elsevier Inc. All rights reserved.