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

Methods

Study design plays a paramount role in the reliability and validity of acceptability data. In randomized clinical trials, which are designed primarily to collect safety and efficacy data, women are assigned to use a particular method. In our study, which was modeled on research conducted in China, Cuba and India,11 Nguyen Thi Nhu Ngoc is vice director, Hung Vuong Hospital, Ho Chi Minh City, Vietnam; Khong Ngoc Am is retired director, Maternal and Child Health and Family Planning, Hanoi Obstetric and Gynecology Hospital, Hanoi, Vietnam; and Do Trong Hieu is chief, Maternal and Child Health Department, Ministry of Health, Hanoi. Beverly Winikoff is director, Reproductive Health; Shelley Clark is consultant; Charlotte Ellertson is program associate; and Batya Elul is staff program associate-all with the Population Council, New York. This study was funded by an anonymous donor. The authors thank Kurus Coyaji and Andrea Eschen for their assistance. women were allowed to choose their abortion method. This design reflects more closely the situation under which the method will be used when offered in a clinic. Thus, a sample of women who have chosen between medical and surgical abortion constitute the correct population from which to generalize about the acceptability of both methods. A drawback, however, is that safety and efficacy data can be generalized only to women who choose between methods.

The study was conducted from January 1995 to April 1996 in the two largest urban centers in Vietnam, Hanoi and Ho Chi Minh City; one clinic in each city participated. Both facilities had legal, established surgical abortion services. Although abortion services in Vietnam generally are of rather poor quality, these clinics had among the best services.

Both sites followed a uniform study protocol. Women seeking abortions could participate if bimanual examination showed that they were no more than eight weeks pregnant (or if it had been no more than 56 days since their last menstrual period), they had no contraindications to medical or surgical abortion, they lived within one hour of the clinic and they were willing to return for follow-up visits. Women aged 35 or older were ineligible if they smoked 10 or more cigarettes per day.

If a woman met the study criteria and wished to participate, a trained provider explained both abortion methods. All women received standardized counseling about both procedures and their most common side effects. For example, women were told that medical abortion is a relatively new method, that it requires taking two sets of pills orally and that after the second set of pills, most women experience cramping for several hours and bleeding for several days.* Moreover, they were informed that in French studies, this medical abortion regimen was about 95% effective. The provider also explained the types of surgical abortion available at the clinic and that this method was nearly 100% effective. Explicit comparisons between medical and surgical abortion were avoided, however, so as not to bias women's selection. After hearing about both methods, women chose between them. Any women who could not decide would have been randomized to a method, but no participants were undecided. All women gave informed consent.