Medical Journal- Safety, Efficacy and Acceptability of Mifepristone-Misoprostol Medical Abortion in Vietnam
Publication date: 1999
10 Only two studies, however, have focused on the potential use of mifepristone and misoprostol for medical abortion in de- veloping countries,4 and only one of these measured the method’s acceptability to clients.5 Given the potential of medical abortion to improve conditions for women in developing countries, these women’s perceptions of the method in general and of the mifepristone-misoprostol regimen in particular is critical to its acceptability. Patients’ attitudes, expectations and toler- ance of side effects influence surgical in- tervention rates; ultimately, for the method to work successfully, women must com- plete the regimen and wait while the treat- ment takes its course. In Vietnam, the number of pregnancy terminations has risen steadily over the past 15 years and is now estimated at more than one million per year;6 since the early 1990s, the annual number of abortions has exceeded the annual number of births.7 A 1994 nationwide survey found that 13% of women have had at least one abortion.8 Moreover, in 1992, the total abortion rate was estimated as 2.5 lifetime abortions per woman, the highest in Asia and the third- highest in the world.9 Additionally, the surgical abortion ser- vices available in Vietnam are marked by a number of safety and quality problems.10 For example, sterilization of instruments Nguyen Thi Nhu Ngoc is vice director, Hung Vuong Hos- pital, Ho Chi Minh City, Vietnam; Khong Ngoc Am is re- tired 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; Shel- ley 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. Safety, Efficacy and Acceptability of Mifepristone- Misoprostol Medical Abortion in Vietnam By Nguyen Thi Nhu Ngoc, Beverly Winikoff, Shelley Clark, Charlotte Ellertson, Khong Ngoc Am, Do Trong Hieu and Batya Elul In the past decade, several nonsurgicaloptions have been developed forwomen seeking to terminate pregnan- cies. To date, however, medical methods of abortion have been officially approved only in several European countries and China. Although women in developed countries benefit from these new options, women in the developing world have a greater need for safe and effective alternatives to surgi- cal abortion: Nearly all of the estimated 70,000 deaths each year due to unsafe abor- tion occur in developing countries.1 The administration of mifepristone, a powerful antiprogestin, coupled with a prostaglandin is a highly effective med- ical method of terminating pregnancy.2 Of the most widely used prostaglandins, gemeprost and misoprostol, the latter shows the greater promise for use in de- veloping countries. Misoprostol can be ad- ministered orally and is inexpensive, sta- ble at ambient temperatures and widely available. By contrast, gemeprost is ex- pensive, not widely available and pro- vided in a vaginal suppository that re- quires refrigeration. In 1993, a large French trial confirmed the safety and efficacy of a regimen consisting of mifepristone and oral misoprostol.3 This regimen, with a success rate of 96%, has been used exten- sively in France and may be available in the United States by the end of 1999. is inadequate in some clinics, and man- agement of pain requires improvement. Indeed, while some women receive no pain medication, others are medicated be- yond the point of conscious sedation and are consequently unable to respond to physical or verbal stimuli. Vietnamese officials have responded to this situation by committing themselves to offering a broader range of contracep- tives. They have also increased efforts to improve the quality of abortion services, including investigating the addition of al- ternatives to surgical abortion. In this article, we describe a study ex- ploring the safety, efficacy and accept- ability of mifepristone-misoprostol med- ical abortion among women attending two clinics in Vietnam. We address three important questions: First, is medical abortion as effective as surgical abortion for women who choose the method? Sec- ond, how do the safety, risks and side ef- fects of medical abortion compare with those of surgical abortion? Third, do women who choose mifepristone-miso- prostol abortion find the method accept- able? Answers to these questions can help policymakers and providers in Vietnam, as well as in other developing countries, determine if medical abortion is a feasi- ble and desirable alternative method of pregnancy termination. Methods Study design plays a paramount role in the reliability and validity of acceptabili- ty data. In randomized clinical trials, which are designed primarily to collect safety and efficacy data, women are as- signed to use a particular method. In our study, which was modeled on research conducted in China, Cuba and India,11 International Family Planning Perspectives Context: In developing countries where the demand for abortion services is high, such as Viet- nam, the need for safe and effective alternatives to surgical abortion is great. Medical abortion using mifepristone and misoprostol may be an appropriate option in some of these countries. Methods: In a comparative study of the safety, efficacy and acceptability of medical and surgi- cal abortion, 393 women at two urban clinics chose between a mifepristone-misoprostol med- ical regimen and the standard surgical procedure offered in each clinic. Results: Success rates for both methods were extremely high (96% for medical abortion and 99% for surgical abortion). Medical abortion patients reported many more side effects than women obtaining surgical procedures (most commonly, cramping, prolonged bleeding and nausea), but none of these side effects represented a serious medical risk. Nearly all women, regardless of the method they chose, were satisfied with their abortion experience. Additionally, among women who had previously undergone surgical abortion, those who selected medical abortion were more likely than those who chose surgery to say that their study abortion was more satisfacto- ry than their earlier one (32% vs. 4%). Conclusions: Mifepristone-misoprostol abortion is safe, effective and acceptable for urban Viet- namese women who are given a choice of methods. If similar results are observed for rural areas, the regimen could help meet the need for abortion services nationwide. International Family Planning Perspectives 1999, 25(1):10–14 & 33 11Volume 25, Number 1, March 1999 two days later, they received 400 mcg of misoprostol orally and were monitored at the clinic for at least four hours. Partici- pants were instructed to return for a fol- low-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 com- plete at the follow-up visit, surgical abor- tion was performed as a backup. Among the 10 women who had backup proce- dures, 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 surgi- cal abortions. They returned later for ad- ditional follow-up. Patients who chose surgical abortion had the procedure on their first visit, in ac- cordance with the clinics’ regular prac- tices. Nearly all of these women (98%) re- ceived vacuum aspiration without dilation. (Two women had vacuum aspi- ration with dilation, and one woman un- derwent 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 conduct- ed 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 re- view of their experiences. Providers collected clinical and experi- ential data from each patient. Questions covered procedures, medications, side ef- fects or problems, and the woman’s reac- tion to the abortion experience. Addi- tionally, 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 women were allowed to choose their abor- tion 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 ac- ceptability 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 partici- pated. Both facilities had legal, established surgical abortion services. Although abor- tion services in Vietnam generally are of rather poor quality, these clinics had among the best services. Both sites followed a uniform study pro- tocol. Women seeking abortions could par- ticipate 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 rela- tively new method, that it requires taking two sets of pills orally and that after the second set of pills, most women experi- ence 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 be- tween 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 unde- cided. All women gave informed consent. Women who chose medical abortion re- ceived 600 mg of mifepristone at their ad- mission visit and remained under obser- vation for 30 minutes. At a second visit, may have been influenced by their earli- er experiences, these women were asked to compare their study abortion and their prior abortion. Data entry and analysis were per- formed using standard statistical software (SPSS) and procedures. All means testing used t-tests, with Levene’s tests conduct- ed to determine whether pooled or sepa- rate variance estimates were appropriate. Chi-square tests were used to analyze cat- egorical data. All tests were two-tailed. Results Sample Characteristics The sample consisted of 393 women—221 in Hanoi and 172 in Ho Chi Minh City. Overall, 260 women chose medical abor- tion and 133 opted for a surgical proce- dure (Table 1).† Women who selected the medical method were slightly younger than those who decided on surgical abortion (26.4 vs. 27.9 years) and had had more years of schooling (11.6 vs. 10.6). Both groups sought to terminate their pregnancies quite early, but the mean gestational age was somewhat lower among women who chose the medical method (5.9 weeks) than among those who opted for surgery (6.1 weeks). Women undergoing medical abor- *If a woman asked how long a medical abortion takes, she was informed that while the majority of women ex- perience a complete abortion within several hours of tak- ing the second set of pills, some wait up to two weeks to have a complete expulsion. †This ratio is not meaningful, because many women who preferred surgical abortion (particularly in Ho Chi Minh City) saw no reason to enroll in the study rather than sim- ply to undergo the standard procedure. Table 1. Selected characteristics of women ob- taining abortions, by method, Hanoi and Ho Chi Minh City, Vietnam, 1995–1996 Characteristic Medical Surgical (N=260) (N=133) Mean age 26.4 27.9** Mean weight (kg) 46.4 46.6 Mean height (cm) 155.8 154.5** Mean education (yrs.) 11.6 10.6** Mean gestational age (wks.) 5.9 6.1* % with first pregnancy 35.4 30.1 % married/in union 73.1 84.2* % who had used contraceptives 37.7 58.6*** % who had had previous abortion 48.5 43.6 *Difference between medical and surgical abortion patients is sig- nificant at p≤.05. **Difference between medical and surgical abor- tion patients is significant at p≤.01. ***Difference between med- ical and surgical abortion patients is significant at p≤.001. Note: While the number of medical patients was roughly equally dis- tributed by site (48% from Hanoi, 52% from Ho Chi Minh City), the distribution of surgical patients was quite uneven (72% from Hanoi, 28% from Ho Chi Minh City). Thus, the background data present- ed for surgical clients are more heavily weighted toward Hanoi. because it entailed fewer visits (28%) or was con- venient (26%). Fear of side effects was not a major concern to women in either group when they selected their method. Only three medical abortion patients did not complete the protocol. One woman, feeling worried and fatigued, went to another clinic be- fore taking misoprostol and obtained a surgical abortion. Another woman did not return to the clinic in time to receive misoprostol and had a surgical intervention. The third woman requested a surgical abortion at another clinic after taking misoprostol because she had expe- rienced only spotting and not heavy bleed- ing. All three are included in the analysis. Efficacy and Safety Since medical abortion clients selected their method to avoid surgery, we con- sidered any of these women who under- went a surgical procedure for any reason to represent a treatment failure.12 All sur- gical abortion patients who had more than one surgical procedure were also deemed to represent treatment failures. Three types of failures can occur among medical patients: user choice, provider choice (or error) and true drug failures. User choice failure occurs when a woman asks for surgical intervention prior to the end of the study or is unable or chooses not to take the complete medical treat- ment. Provider choice failure occurs when a provider performs or recommends med- ically unwarranted surgical interventions (either out of impatience or in reaction to a concern with no clear medical basis). True drug failure occurs when an adverse event requires surgical intervention dur- ing the study period or when an abortion is not complete by the end of the study. Failure rates for both abortion methods were extremely low (Table 3). Only one surgical patient (1%) required a backup in- tervention. Among medical patients, there were 10 failures (for a rate of 4%): six user choice, one provider choice and three true drug failures.* Diligent efforts were made to minimize loss to follow-up. All women who did not report for a scheduled appointment were sent up to three reminder letters. Only after providers made home visits in an effort to trace these patients were the women des- ignated as lost to follow-up. In total, nine tion were less likely than those having sur- gical procedures to be married (73% vs. 84%) and to have been using a contracep- tive (38% vs. 59%). The differences in age and length of gestation, however, were no longer statistically significant once we con- trolled for study site (not shown). Method Choice and Adherence to Protocol Upon enrollment in the study, women were asked to name up to three reasons for their method selection. Among women who se- lected the medical method, 59% did so to avoid pain (Table 2). Substantial proportions also chose the medical method to avoid surgery or anesthesia (43%), or because they believed that it was the safer option (40%) or that it would be less traumatic (30%). In contrast, women choosing surgical abortion did so mainly because they per- ceived it to be simpler and faster (68%) or more effective (64%) than medical abortion. As with the medical patients, safety con- cerns loomed large in the minds of surgi- cal patients (47%). Large proportions of women also decided to undergo surgery surgical patients (7%) and three medical abortion patients (1%) were lost to follow- up. All available data from these 12 women are included in our analysis. Side effects—nausea, vomiting, cramp- ing, pain, diarrhea and bleeding—were far more common among the medical abor- tion clients than among the women who chose surgery (Table 3). However, al- though we have included cramping and bleeding as side effects, they may be symptoms of a medical abortion; indeed, if they do not occur, the woman is unlikely to have a successful medical abortion. Furthermore, medical abortion patients were observed on more occasions (at least three visits vs. at least two) and for a longer period of time (17 vs. 15 days) than were surgical abortion patients. More im- portant, even for medical clients, none of the observed side effects represented a se- rious medical risk. Side effects of medical abortion varied at different stages of the procedure (Table 4). Women were more likely to report nau- sea and vomiting after taking mifepristone than later in the abortion process, but this may reflect symptoms of pregnancy. (In- deed, upon enrollment in the study, 43% of all women reported nausea—42% who chose medical abortion and 46% who opted for surgical—and 6% reported vom- iting.) Cramping and abdominal pain in- creased sharply during the four-hour ob- servation period immediately after administration of misoprostol, but sub- sided later. Profuse bleeding, although never experienced by more than 5% of the medical abortion clients, was also most likely during these four hours. 12 International Family Planning Perspectives Mifepristone-Misoprostol Medical Abortion in Vietnam Table 2. Percentage of abortion patients citing various reasons for selecting their method, by method Reason Medical Surgical (N=258) (N=131) Effective 5.4 64.1 Simpler and faster † 67.9 Less pain 58.9 † Safer 40.4 47.3 Avoids surgery/anesthesia 43.4 † Easier emotionally 30.2 † Fewer visits † 27.5 Convenient 7.8 26.0 Less bleeding † 7.6 More natural 6.2 † Private 5.8 † Fewer side effects † 3.8 †Cited by one woman or no women. Note: Women could cite up to three reasons. *At the follow-up visit, three medical abortion patients had had incomplete abortions and were permitted to keep waiting for their abortions to become complete. Two of these women had complete abortions confirmed when they returned for an additional follow-up visit, a few days to one month after the first; the third woman received a surgical intervention, because her abortion still was not complete three days after her initial follow-up visit. Table 3. Percentage distribution of abortion patients, by outcome, and percentage of pa- tients citing various side effects, by method Measure Medical Surgical (N=257) (N=124) Outcome Successful abortion 96.1 99.2 Failure 3.9 0.8 Total 100.0 100.0 Side effects Nausea 39.3 0.8*** Vomiting 17.1 2.4*** Cramping/abdominal pain 96.1 37.1*** Diarrhea 5.8 0.0** Profuse bleeding 8.9 4.8 Prolonged bleeding 80.5 25.8*** **Difference between medical and surgical abortion patients is significant at p≤.01. ***Difference between medical and surgical abortion patients is significant at p≤.001. Note: Patients who were lost to follow-up are excluded. Table 4. Percentage of medical abortion patients experiencing various side effects, by segment of the regimen Side effect After mifepri- During obser- After obser- stone, before vation after vation, until misoprostol misoprostol exit (N=258) (N=259) (N=257) Nausea 37.6 6.9 6.2 Vomiting 15.9 0.8 2.3 Cramping/abdominal pain 38.8 93.8 37.7 Diarrhea 1.2 3.1 2.7 Prolonged bleeding 0.0 0.0 80.5 Profuse bleeding 2.7 4.2 2.3 Increased bleeding 0.0 94.6 0.0 Note: The observation period after administration of misoprostol was at least four hours. 13Volume 25, Number 1, March 1999 medically induced abortions took place on the day the women received misoprostol, and 8% took place throughout the next two weeks. However, medical abortion early in gestation can escape detection; 10% of medical abortion patients did not recog- nize when their abortions occurred. Most medical patients could identify where they were when the abortion oc- curred (even if they could not pinpoint the time of the abortion). Nearly three-quarters (72%) reported that their abortions occurred at the clinic, but many (20%) said theirs oc- curred at home. About 1% reported other locations, and the rest were unsure. At the exit visit, all but one patient (who had had a surgical procedure) stated that the explanation they had received about their method adequately prepared them for the abortion experience. The remain- ing woman reported that the experience was worse than she had expected it to be. The vast majority of women were satis- fied with their abortion experience—97% of those who had medical procedures and 95% who had surgical abortions (Table 6). Of the 13 women who were not satisfied with the experience, five had had method failures. Nevertheless, about half of women who had failures remained satisfied with their abortions. A patient who had under- gone a surgical intervention after the med- ical procedure failed concluded that there was nothing wrong with the medical method, but that she was simply “unlucky.” In all, 178 women had had a previous surgical abortion—60% vacuum aspira- tion, 37% dilation and curettage, and 3% some other surgical procedure. When asked how their experience during the study compared with their previous abor- tion experience, women who had medical abortions were significantly more likely than those who had surgical procedures to say that their study experience was more satisfactory (32% vs. 4%). Medical clients were less likely than surgical clients to report that the study abortion was not as satisfactory as their previous abortion (3% vs. 11%). Women who had medical abortions were significantly more likely to say they would select the same method again than were those who selected surgical abortion (96% vs. 52%). Nearly all (95%) medical abortion clients would recommend their method, compared with only 28% of sur- gical abortion clients. Additionally, 37% of surgical abortion clients would recommend medical abortion to friends, while only 2% of medical abor- tion clients would recommend surgical abortion. Thus, in hindsight, some of the Among the most serious risks of abor- tion, regardless of the method used, is ex- cessive blood loss during and following the procedure. On average, the women in both groups experienced minimal blood loss (Table 5). Only 2% of women who had medical abortions and 1% of their coun- terparts who had surgical procedures ex- perienced a reduction in their hemoglo- bin levels of greater than 2 g per deciliter (which is considered clinically meaning- ful blood loss), and none required a trans- fusion (not shown). Analysis of participants’ diaries showed that medical abortion clients reported more blood loss than did surgical abortion patients. The mean number of days of bleeding (i.e., heavy, normal or light) was significantly greater for women who had medical abortions than for those who had surgical abortions.* For both groups, how- ever, heavy bleeding accounted for only a small number of total bleeding days. Expectations about both the amount and the duration of bleeding also differed between the medical and surgical groups. Medical abortion patients were more like- ly than surgical patients to have bled more and longer than they had expected to. Acceptability Where and when an abortion occurs after a medical procedure may significantly in- fluence the method’s acceptability. Ac- cording to participants’ diaries, 82% of surgical abortion clients believed that the alternative procedure was preferable to the one they had chosen, perhaps because of discussions they had with women who ob- tained the other procedure. At their final visit, women were asked to describe the best and worst aspects of their abortion method (Table 7, page 14). Each was permitted up to three answers. For medical abortion, the features most frequently cited by patients were that the method is less painful than surgical abor- tion (35%), is safer (30%), does not involve surgery (20%) and is effective (14%). The emphasis on less pain is not surprising, given that surgical abortion is delivered with minimal anesthesia in Vietnam. Prolonged heavy bleeding was most commonly reported as the worst feature of medical abortion (mentioned by 39% of women). A substantial proportion of med- ical clients (17%) also reported that the method involved too many visits and too lengthy a follow-up. Some 30% of women who had medical abortions, however, were unable to offer any negative features of the method. Women who chose surgical abortion clearly appreciated the method’s effec- tiveness (46%), as well as the ease and sim- plicity of the procedure (23%). Yet 23% Table 5. Measures of bleeding experienced by abortion patients, by method Measure Medical Surgical MEANS Hemoglobin level (g/dl) (N=253) (N=123) At entry 11.8 11.6 At exit 11.7 11.6 Change –0.1 –0.1 Days of bleeding*** (N=257) (N=124) Heavier than usual menses 1.3 (2.2) 0.4 (0.8) Like normal menses 3.1 (2.7) 2.2 (1.2) Lighter than usual menses 6.2 (3.5) 3.1 (1.7) PERCENTAGE DISTRIBUTIONS Amount of bleeding* (N=257) (N=124) More than expected 25.3 16.9 As much as expected 57.2 65.3 Less than expected 16.0 11.3 Not sure/do not know 1.6 6.5 Duration of bleeding*** (N=257) (N=124) Longer than expected 49.0 24.2 As long as expected 34.2 58.1 Shorter than expected 14.8 11.3 Not sure/do not know 1.9 6.5 Total 100.0 100.0 *Difference in distribution between medical and surgical abortion patients is significant at p≤.05. ***Difference in distribution be- tween medical and surgical abortion patients is significant at p≤.001. Notes: For days of bleeding, numbers in parentheses are standard deviations. *Analysis of the mean number of days of bleeding, how- ever, overestimates the total number of days of bleed- ing, since diary entries recording different types of bleed- ing on a single day were counted as separate days of bleeding. Thus, for example, if a woman recorded both normal and heavy bleeding one day, she was counted as having had a full day of each. Table 6. Percentage distribution of abortion patients, by measure of satisfaction with their method, according to method Measure Medical Surgical Satisfaction (N=257) (N=124) Highly satisfied 5.4 2.4 Satisfied 91.8 92.7 Not satisfied 2.7 4.8 Would choose method again*** (N=256) (N=123) Yes 95.7 51.6 No 4.3 48.4 Would recommend method*** (N=251) (N=124) Medical 95.2 37.1 Surgical 2.0 28.2 Either 2.8 34.7 Comparison with previous abortion*** (N=121) (N=57) More satisfactory 32.2 3.5 As satisfactory 64.5 86.0 Less satisfactory 3.3 10.5 Total 100.0 100.0 ***Difference in distributions between medical and surgical abor- tion patients is significant at p≤.001. ployed and suggests that the date of the follow-up visit can be successfully delayed beyond the current standard of two weeks, which has been adopted from the surgical regimen. Side effects were more common among medical abortion clients than among sur- gical clients, but they did not jeopardize the safety of the medical regimen and were tolerable for the vast majority of women who chose that method. Howev- er, women who had medical abortions re- ported bleeding more and longer than they had expected and more frequently than women who obtained surgical pro- cedures. Since women’s expectations may significantly affect their comfort and sat- isfaction with a method, medical abortion patients must receive appropriate advance information to prepare them for the method’s potential side effects. This trial was conducted in major clin- ics in large urban areas, where backup fa- cilities are easily accessible and of rea- sonably high quality. Studies in rural areas with more basic facilities are needed be- fore the method’s safety, effectiveness and acceptability for women throughout the country can be judged. Additionally, since many medical abortion clients reported that the regimen involved too many vis- its and many surgical clients chose their method because it entailed fewer visits, research into a simplified protocol in- volving fewer clinic visits is important. Nevertheless, our results indicate that mifepristone-misoprostol medical abor- tion can complement available surgical services and help meet the pressing need for safe, effective and acceptable abortion services in Vietnam. References 1. World Health Organization, Abortion: A Tabulation of Available Data on the Frequency and Mortality of Unsafe Abor- tion, second ed., Geneva: World Health Organization, 1994. 2. Bygdeman M et al., Progesterone receptor blockage: effect on uterine contractility and early pregnancy, Con- traception, 1985, 32(1):45–51. 3. Peyron R et al., Early termination of pregnancy with mifepristone (RU 486) and the orally active prostaglandin misoprostol, New England Journal of Medicine, 1993, 328(21):1509–1513. 4. He C et al., Study on safety and efficacy of mifepris- tone plus misoprostol for termination of early pregnan- cy, Reproduction and Contraception, 1992, 3:1–10; and Winikoff B et al., Safety, efficacy, and acceptability of med- ical abortion in China, Cuba, and India: a comparative trial of mifepristone-misoprostol versus surgical abor- tion, American Journal of Obstetrics and Gynecology, 1997, 176(2):431–437. 5. Winikoff B et al., 1997, op. cit. (see reference 4). 6. Goodkind D, Abortion in Vietnam: measurements, puzzles, and concerns, Studies in Family Planning, 1994, were unable to name any good charac- teristics of the method. Although surgi- cal abortion clients reported far less pain during the study than did medical clients, 57% considered pain the method’s worst feature. Surgical clients also included fear of surgery and mental stress among the worst features of their method. Discussion Our findings suggest that mifepristone- misoprostol medical abortion is a safe, ef- fective and desirable alternative to surgical abortion in Vietnam. The method’s success rate in our study (96%) is the highest docu- mented in a developing country13 and is comparable to the rate found in developed countries.14 Moreover, while the medical abortion failure rate in our study exceeds that of the surgical method, many Vietnamese women apparently are willing to accept an increased risk of failure, since most said they would choose medical abortion again and would recommend it to their friends. Three women whose pregnancies had not yet terminated as of their exit visits were advised to return for additional fol- low-up rather than receive surgical inter- vention. Two had had complete abortions by the time they returned and thus re- quired no backup procedure, while the third eventually received sharp curettage to complete her abortion. This experience confirms that the method’s failure rate is largely a function of the protocol em- 25(6, part 1):342–352. 7. Johansson A et al., Abortion in context: women’s ex- perience in two villages in Thai Binh Province, Vietnam, International Family Planning Perspectives, 1996, 22(3): 103–107. 8. Statistical Publishing House, Vietnam Intercensal De- mographic Survey, 1994: Major Findings, Hanoi, Vietnam: Statistical Publishing House, 1995. 9. Goodkind D, 1994, op. cit. (see reference 6). 10. Vietnamese Ministry of Health, A strategic assessment of policy, programme and research issues relating to abor- tion in Vietnam: a draft report, Hanoi, Vietnam, 1997. 11. Winikoff B et al., The acceptability of medical abor- tion in China, Cuba and India, International Family Plan- ning Perspectives, 1997, 23(2):73–78 & 89; and Winikoff B et al., 1997, op cit. (see reference 4). 12. Winikoff B et al., Analysis of failure in medical abor- tion, Contraception, 1996, 54(6):323–327. 13. Winikoff B et al., 1997, op. cit. (see reference 11); and Winikoff B et al., 1997, op. cit. (see reference 4). 14. Winikoff B et al., 1997, op. cit. (see reference 4); Pey- ron R et al., 1993, op. cit. (see reference 3); and Aubény E et al., Termination of early pregnancy (up to and after 63 days of amenorrhea) with mifepristone (RU 486) and increasing doses of misoprostol, International Journal of Fertility, 1995, 40(Suppl. 2):85–91. Resumen Contexto: En los países en desarrollo donde es elevada la demanda de servicios de aborto, tales como Vietnam, es enorme la necesidad que existe de contar con alternativas seguras y efi- caces para evitar la intervención quirúrgica. Una buena opción en algunos de estos países puede ser el aborto médico realizado median- te el uso del mifepristone y el misoprostol. Métodos: En un estudio comparativo realiza- do sobre la seguridad, la eficacia y la aceptabili- dad de los abortos médico y quirúrgico, 393 mu- jeres de dos clínicas urbanas eligieron entre el método médico en base a mifepristone y miso- prostol y el procedimiento quirúrgico estándar. Resultados: Las tasas de éxito para ambos métodos resultaron extremadamente elevadas (96% para el aborto médico y 99% para el abor- to quirúrgico). Las pacientes del aborto médi- co indicaron un número mucho mayor de efec- tos secundarios que las que se sometieron a procedimientos quirúrgicos (más comúnmente dolores, sangrado prolongado y náuseas), aun- que ninguno de estos efectos secundarios re- presentó un riesgo médico serio. Casi todas las mujeres, fuere cual fuere el método escogido, se mostraron satisfechas con su experiencia. Además, entre las mujeres que previamente se habían sometido a un aborto quirúrgico, aque- llas que escogieron un aborto médico eran más proclives que las que dicidieron de someterse a un aborto quirúrgico a indicar que su abor- to actual era más satisfactorio que el anterior (32% contra 4%). Conclusiones: El aborto médico en base a mi- fepristone y misoprostol es seguro, eficaz y 14 International Family Planning Perspectives Mifepristone-Misoprostol Medical Abortion in Vietnam Table 7. Percentage of abortion patients cit- ing various features as their method’s best and worst characteristic, by method Feature Medical Surgical (N=257) (N=124) Best Effective 14.4 46.0 Less pain 34.6 † Safer/less risk of complication 30.4 7.3 Faster/easier/simpler 5.1 23.4 None/not sure 8.2 22.6 Avoids surgery 19.8 † Less mental stress/ healthier 7.4 † Convenient/compatible with duties 6.6 4.0 Worst Pain † 57.3 Prolonged heavy bleeding 38.9 22.6 None/not sure 30.0 18.5 Too many visits/lengthy follow-up 16.7 † Fear of surgery † 10.5 More mental stress † 8.9 Long waiting time until abortion 7.8 † Fatigue/dizziness 5.1 † †Cited by one woman or no women. Note: Women could cite up to three reasons. (continued on page 33) 33Volume 25, Number 1, March 1999 Medical Abortion in Vietnam. (continued from page 14) aceptable para las mujeres vietnamitas de zonas urbanas que tienen la opción de escoger un método. Si se observan resultados simila- res en las zonas rurales, este sistema podría sa- tisfacer la necesidad insatisfecha de servicios de aborto que existe a nivel nacional en el país. Résumé Contexte: Dans les pays en voie de dévelop- pement qui présentent une demande de services d’avortement élevée (le Viet Nam, par exemple), il existe un besoin important de solutions súres et efficaces autres que les procédures chirurgi- cales. L’avortement médical à base de mife- pristone et de misoprostol pourrait offrir une option viable dans certains de ces pays. Méthodes: Dans une étude comparative de la sécurité, de l’efficacité et de l’acceptabilité de l’avortement médical et chirurgical, 393 femmes rencontrées dans deux cliniques ur- baines ont choisi entre un régime médical à base de mifepristone-misoprostol et la procédure chi- rurgicale ordinaire offerte dans chaque clinique. Résultats: Les taux de succès des deux mé- thodes se sont avérés extrÍmement élevés (96% pour l’avortement médical et 99% pour la mé- thode chirurgicale). Les patientes ayant choi- si la procédure médicale ont signalé beaucoup plus d’effets secondaires que celles qui avaient demandé l’intervention chirurgicale (douleurs abdominales, saignements prolongés et nau- sées, surtout), mais aucun de ces effets ne pré- sentait de risque médical grave. Indépendam- ment de la méthode choisie, presque toutes les femmes se sont déclarées satisfaites de leur ex- périence. De celles qui avaient subi un avor- tement chirurgical précédent, celles ayant choi- si la procédure médicale se sont du reste révélées plus susceptibles, par rapport à leurs homologues qui avaient de nouveau choisi la méthode chirurgicale, de qualifier la procédu- re incluse dans l’étude de plus satisfaisante que la précédente (32% par rapport à 4%). Conclusions: L’avortement provoqué par mi- fepristone-misoprostol offre une méthode súre, efficace et acceptable aux yeux des Vietna- miennes auxquelles un choix de méthode est offert. Si des résultats comparables étaient ob- servés dans les milieux ruraux, le régime pour- rait aider à répondre au besoin de services d’avortement à l’échelle nationale.
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