Safety, efficacy and acceptability of mifepristone-misoprostol medical abortion in Vietnam

International Family Planning Perspectives, Mar 1999 by Ngoc, Nguyen Thi Nhu, Winikoff, Beverly, Clark, Shelley, Ellertson, Charlotte, Et al

Women who chose medical abortion received 600 mg of mifepristone at their admission visit and remained under observation for 30 minutes. At a second visit, two days later, they received 400 mcg of misoprostol orally and were monitored at the clinic for at least four hours. Participants were instructed to return for a follow-up exam and an exit interview 14 days later, and were told to come to the clinic at any time before then if they were worried or if they changed their mind about the method. The women were not given any medication to control pain, since such medications are easily available over the counter in Vietnam.

Generally, if the abortion was not complete at the follow-up visit, surgical abortion. was performed as a backup. Among the 10 women who had backup procedures, five underwent vacuum aspiration and three had sharp curettage; the method was unknown for the other two. Three women whose abortions were incomplete at the follow-up visit were permitted to keep waiting rather than receiving surgical abortions. They returned later for additional follow-up.

Patients who chose surgical abortion had the procedure on their first visit, in accordance with the clinics' regular practices. Nearly all of these women (98%) received vacuum aspiration without dilation. (Two women had vacuum aspiration with dilation, and one woman underwent sharp curettage.) In Ho Chi Minh City, all surgical abortion patients received local anesthesia, while in Hanoi, most did not receive any anesthesia. Fourteen days after the procedure, patients returned to the clinic for a checkup and exit interview.

Clinic physicians were already trained in providing surgical abortions and received additional training in medical abortion for the study. They provided all of the surgical procedures, administered about half of the medical abortions and supervised the nurses who administered the other half. The in-country principal investigators closely monitored the study to ensure standardized treatment. Before the main study began, each site conducted a pilot study of 10 medical patients. Data on these women are included in our analyses, since no significant changes were made to the protocol following review of their experiences.

Providers collected clinical and experiential data from each patient. Questions covered procedures, medications, side effects or problems, and the woman's reaction to the abortion experience. Additionally, women completed a daily diary of all side effects during the weeks of the study and indicated when they thought their abortion had occurred. Finally, since women who had had previous abortions may have been influenced by their earlier experiences, these women were asked to compare their study abortion and their prior abortion.

Data entry and analysis were performed using standard statistical software (SPSS) and procedures. All means testing used t-tests, with Levene's tests conducted to determine whether pooled or separate variance estimates were appropriate. Chi-square tests were used to analyze categorical data. All tests were two-tailed.