Mifepristone versus misoprostol for cervical preparation prior to surgical abortion between 11 to 15 weeks gestational age: a double-blind, randomized trial
Awarded 2012
Complex Family Planning Fellowship Research
David Kattan, MD
Boston Medical Center

Background: For women seeking abortion between 11 and 15 weeks of pregnancy, a drug called misoprostol is often used to help open the cervix (the opening between the vagina and uterus). This process takes about three hours. The abortion procedure is then performed. Misoprostol commonly causes side effects like vaginal bleeding, abdominal cramping, and diarrhea. Another medication called mifepristone has been shown to be as good or better than misoprostol at opening the cervix for pregnancies earlier than 11 weeks. Mifepristone is taken 24-48 hours prior to an abortion, and usually causes less vaginal bleeding, abdominal cramping, and diarrhea than misoprostol does. If mifepristone opened the cervix between 11 and 15 weeks of pregnancy as well or better than misoprostol, women would be able to choose which medication they receive before their abortion.
Purpose: To see if mifepristone is as good or better than misoprostol for opening the cervix before an abortion procedure at 11 to 15 weeks of pregnancy.
Methods: The study started the day of the patient’s preoperative appointment. If the patient chose to participate in the study, they were assigned to be in one of two groups. One group received mifepristone and the other group received misoprostol. The groups were decided randomly, like flipping a coin. Each woman had a 50-50 chance of being in either group. Each participate did not have a choice about which group they were in. The researchers or the doctor did not know which group each participant was in until the study was over. After deciding to be part of the study, subjects received a capsule to swallow. Women in Group A received a mifepristone capsule, and women in Group B received a Vitamin C capsule. Subjects were then given a package containing two tablets to be used on the day of the abortion. Women in Group A received folic acid, a vitamin, and women in Group B received misoprostol. On the day of the abortion, subjects placed the tablets between their cheek and gums. Subjects waited 3 hours after placing the tablets from the package before the abortion was performed. Subjects were asked questions about their symptoms before the abortion was performed. The doctor then performed the abortion procedure in the usual way, using suction to remove the pregnancy. Right after the abortion procedure, a study assistant asked subjects about their experiences. After this interview, the subjects had completed their participation in the study.
Important Findings and Conclusion: This study was not completed due to poor enrollment and therefore no findings or conclusions are made. The reasons behind the difficulty in enrollment are unclear. One possibility is that subjects could not easily commit to undergoing their abortion procedure within the 24-48 hours after the preoperative encounter that the protocol required.