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Acceptability and feasibility of mifepristone-misoprostol for menstrual regulation in bangladesh

Acceptability and Feasibility of Mifepristone-Misoprostol
For Menstrual Regulation in Bangladesh

CONTEXT: Annually, more than 700,000 women turn to menstrual regulation, or uterine evacuation with vacuum
aspiration; many more resort to unsafe abortion. Using pills for the evacuation of the uterus could increase women’s access to safe menstrual regulation services and reduce the high levels of abortion- and menstrual regulation– Johnston, Sheila Raghavan, Noushin METHODS: At 10 facilities in Bangladesh, 651 consenting women who were seeking menstrual regulation services
and who were 63 days or less past their last menstrual period received 200 mg of mifepristone followed 24 hours later by 800 mcg of buccal misoprostol, administered either at home or in the clinic. Prospective data were collected to determine women’s experience and satisfaction with the procedure, menstrual regulation outcome, and the human and physical resources required for providing the method. Focus group discussions were conducted with a purposively sampled group of service providers at each site to understand their attitudes about the introduction of Anadil Alam is senior research investiga- menstrual regulation with medication. tor; Noushin Islam is research investigator; RESULTS: The majority of women (93%) with known menstrual regulation outcomes evacuated the uterus without
surgical intervention. Overall, most women (92%) were satisfied with use of pills for their menstrual regulation. bach is director, Cen-ter of Reproductive Providers faced initial challenges and concerns, particularly related to the additional counseling requirements and lack of control over the final outcome, but became more confident after successful use of the medication regimen. Dhaka, Bangladesh. Hillary Bracken CONCLUSIONS: Mifepristone-misoprostol can be safely offered within existing menstrual regulation services in
urban and periurban areas in Bangladesh and is highly acceptable to women. Providers’ initial concerns diminish Raghavan is program associate and Beverly with increased experience with the method. International Perspectives on Sexual and Reproductive Health, 2013, 39(2):79-87, doi: 10.1363/3907913 all at Gynuity Health Projects, New York. Heidi Bart Johnston is Menstrual regulation, or the evacuation of the uterus of a to significantly underreport the actual number of cases; a senior scientist, Swiss woman at risk of being pregnant to ensure a state of non- recent study estimated 653,000 per year.5 Tropical and Public Health Institute and pregnancy, was introduced in Bangladesh in the 1970s in Although menstrual regulation services have been de- the context of a restrictive abortion law, in part to reduce centralized and are officially available free of charge in the Switzerland. maternal morbidity and mortality associated with unsafe public sector, many women lack access to these services. abortion.1,2 The introduction of menstrual regulation also In a recent study, Bangladeshi women described a range coincided with the Bangladesh Liberation War, during of socioeconomic barriers that affected their access to which 200,000–400,000 Bangladeshi women were the menstrual regulation services and contributed to delays in victims of rape; the new government allowed abortions obtaining these services.6 In that study, cost, social stigma for those who had become pregnant.3 Under the Ban- and fear of the procedure were identified as the main ob- gladesh Menstrual Regulation program, manual vacuum stacles to obtaining safe menstrual regulation services. aspiration is provided free of cost at primary, secondary The cost barrier is pervasive. One study found that among and tertiary levels of the public-sector health system. Men- menstrual regulation clients, only 11% of women reported strual regulation services are also provided, for a fee, in receiving free services, even though services obtained in some nongovernmental organization clinics and private- the public sector are supposed to be free of cost.7 Addi- sector clinics in Bangladesh. Physicians are permitted to tional costs are incurred if the woman is beyond the legal perform menstrual regulation up to 10 weeks’ amenor- limit for number of days since last menstrual period, and rhea and midlevel providers (family welfare visitors or these costs tend to increase with gestational age.
paramedics) up to eight weeks’ amenorrhea. By the end Low levels of education and lack of awareness of men- of 2011, approximately 10,600 doctors and 7,200 family strual regulation services also affect access. Most women welfare visitors and paramedics had been trained in the report unofficial sources such as relatives, friends and provision of menstrual regulation.4 Government Manage- neighbors as their main source of information about men- ment Information System data report 200,000 menstrual strual regulation; only 9% of menstrual regulation users regulation cases each year, but this is generally considered were told about services by trained family planning work- Acceptability and Feasibility of Medication Menstrual Regulation in Bangladesh ers.8–10 Barriers to safe and legal menstrual regulation may all, 651 women were recruited for the study. Given the lack lead women to turn to illegal and unsafe abortion proce- of differences in the primary outcome between the two dures. According to a recent study, more than 230,000 study phases, the data were merged for analysis. However, women were treated for complications of unsafe abortion we report comparisons of secondary outcomes (side ef- and menstrual regulation in 2010;5 the study identified fects, bleeding) in which significant differences were found.
more than 78,000 women treated for complications re- All women seeking menstrual regulation services at par- lated to menstrual regulation in that year. Because not all ticipating clinics were asked if they wanted to enroll in a women who develop complications obtain treatment, the trial of medication menstrual regulation. Women were true number of women experiencing complications from eligible if they were 18 years or older; amenorrheic for up menstrual regulation and unsafe abortion is expected to to nine weeks on the day of mifepristone administration; be much higher. Incremental costs to the health system of in good health, with no contraindications to mifepristone managing complications of unsafe abortion are estimated or misoprostol; willing to provide a urine sample; and able and willing to provide a telephone number for the Use of pills for the evacuation of the uterus, in lieu of sur- purposes of follow-up. Amenorrhea was calculated using gical intervention, may help increase access to safe menstru- standard methods for menstrual regulation: the date of last al regulation services and potentially reduce the high levels menses and bimanual exam. In phase-one sites, the exam of abortion and menstrual regulation–related morbidity in and assessment were performed by physicians exclusively. Bangladesh. Mifepristone is an antiprogestin licensed for In phase-two sites, midlevel providers performed 7% of the pregnancy termination in more than 40 countries around assessments. Although ultrasound could be used if the pro- the world.12 Mifepristone followed by a prostaglandin ana- vider needed to rule out pathology or unexplained discrep- log, most commonly misoprostol, has been shown to be ancies between other methods of eligibility assessment, safe and effective up to nine weeks (63 days) of pregnancy13 there were no cases in which this was considered neces- and is the method of abortion recommended by the World sary. Women who elected to take part and met the study Health Organization.14 However, the acceptability and feasi- criteria were enrolled after giving informed consent, by pro- bility of this method for women and providers have not pre- viding either their signature or their thumbprint. Women viously been examined in Bangladesh. This study assessed were compensated 150 Taka (US$1.84) to cover the cost the feasibility and acceptability of a simplified mifepristone- of transportation to the study clinic for the follow-up visit.
misoprostol regimen for menstrual regulation in 10 facili- Pregnancy testing is not routinely performed prior to ties in Bangladesh. The ethical review board at icddr,b ap- menstrual regulation in Bangladesh. However, to facilitate proved the protocol prior to the start of the study.
comparisons with international experience with such regi-mens for medication abortion, all women were asked to provide a urine sample for laboratory analyses prior to ad- Women seeking menstrual regulation services were re- ministration of mifepristone. Almost all women (N=650) cruited for a trial of medication menstrual regulation at 10 provided a sample. Each sample was labeled with a unique centers in two phases between July 2009 and April 2010. study ID number and stored frozen at the study site. Af- In the first phase of the research, July–October 2009, wom- ter a woman completed the exit interview, the sample was en were recruited at three tertiary-care facilities located transported by icddr,b staff to the organization’s labora- in Dhaka city. Two of these sites are training centers for tory and a pregnancy test was performed on the sample menstrual regulation services located in government hos- using the Genzyme™ HCG Card pregnancy test.
pitals: Reproductive Health Services Training and Program After oral administration of 200 mg of mifepristone at (RHSTEP) Sir Salimullah Medical College & Mitford Hos- the clinic, most women were offered the choice of either pital and RHSTEP Dhaka Medical College Hospital. The returning 24 hours later to take 800 mcg misoprostol or third site, the Marie Stopes Premium Clinic, is a 24-hour of taking the misoprostol at home. The first 5–10 women private facility offering menstrual regulation services. In all recruited at each clinic were required to return to take the phase-one sites, physicians handled almost all aspects of misoprostol on site to increase provider familiarity with treatment, making eligibility assessments, administering the drug’s administration; in all, 81 women were required medication and evaluating the success of the menstrual to take the misoprostol in the clinic. All women were regulation. During the second phase of the research, from counseled to take the misoprostol buccally, i.e., by hold- December 2009 to April 2010, women were recruited at ing two tablets between each cheek and gum for about 30 seven nongovernmental sites in urban and periurban minutes. Women were given a mild analgesic (two 500-mg areas outside Dhaka city (Bangladesh Association for paracetamol tablets) to take as needed. All participants Prevention of Septic Abortion [BAPSA], Gazipur; BAPSA, received instructions on where to seek around-the-clock Mirpur; Bangladesh Women’s Health Coalition, Narayan- help in case of concerns or emergencies.
ganj; Family Planning Association of Bangladesh [FPAB], Women were asked to return to the clinic 10–14 days Chittagong; FPAB, Rajshahi; Marie Stopes, Sylhet; RHSTEP, following their initial visit to determine the success of the Mymensingh). At the phase-two sites, menstrual regulation procedure. At the follow-up visit, providers took a short services were provided by physicians and paramedics. In history and asked women to describe the bleeding experi- International Perspectives on Sexual and Reproductive Health enced after mifepristone and misoprostol administration. A TABLE 1. Selected social and demographic characteristics
bimanual examination was performed to assess uterine size of women seeking menstrual regulation with medication at
and confirm any change since the initial exam. Providers 10 facilities in Bangladesh, 2009–2010
also confirmed and documented any symptoms suggesting a potential complication, including tenderness on exam, fe- ver, pain or excessive blood loss. In phase-one sites, all of the follow-up exams were performed by a physician. In phase- Means
Age in yrs. (range)
two sites, 23% were performed by a midlevel provider.
If the results of the follow-up exam confirmed a state of nonpregnancy and no symptoms suggested a need for Percentages
additional care, the procedure was considered successful. According to the study protocol, if the provider was not certain of the outcome following the clinical exam, ultra- sound could be used to evaluate the success of the proce- dure, but there were no cases in which this was considered necessary. However, in one case, at an unscheduled visit eight days after misoprostol administration, an ultrasound Note: Unless otherwise noted, figures in parentheses are standard was performed because of a suspected ectopic pregnancy; an ectopic pregnancy was confirmed and appropriate management was provided.
subthemes. A constant comparative approach was used, If the provider identified an increase in uterine size con- in which the responses from different respondents were sistent with an ongoing pregnancy at the follow-up visit, compared to identify similarities and differences. Thematic the procedure was considered to have failed and a manual analysis of data was done manually using content analysis.
vacuum aspiration was performed. If the provider con-firmed a return of the uterus to prepregnancy size, but was Analyses
not confident that the uterus had been emptied, the wom- The principal analysis compared the menstrual regulation an was offered a surgical intervention (uterine evacuation) outcomes in the women recruited during the two phases or an additional follow-up visit (with or without adminis- of the study using merged data; there were no significant tering another dose of 800 mcg buccal misoprostol), de- differences between the two study phases. Thus, data are pending on the evaluation of the clinician and the choice presented for the full sample. The chi-square or Fisher ex- of the woman. Women could request a surgical evacuation act test, as appropriate, was used for independent nominal data, and statistical significance was defined at p≤.05. Data When the procedure was complete, participants were were analyzed using SPSS version 15.0.
asked a series of questions assessing their experiences The success of the mifepristone-misoprostol regimen of the procedure and their satisfaction with the method. was defined as completion of the menstrual regulation Family planning counseling and methods were provided without the need for a surgical evacuation. Studies on this per standard practice at the study sites.
regimen in other settings have found success rates of 95–98%.15–17 Studies have shown slightly lower success rates Focus Group Discussions
when medication abortion is first introduced into existing At the conclusion of the study, a focus group discussion services because providers with less experience with the was conducted at each site with a purposively sampled procedure may be more likely to intervene surgically rath- group of service providers, including doctors, counselors, er than practice expectant management when the uterus is paramedics and clinic administrative staff. There were 10 not completely emptied.18 An efficacy rate of 85% would be focus group discussions, with 40 participants, in all; each feasible for implementation in clinics in Bangladesh, as the group discussion included four people and lasted ap- method would present a viable alternative to the standard proximately 30–45 minutes. A semistructured discussion vacuum aspiration services currently offered in these set- guide focused on providers’ attitudes about mifepristone- tings. To have 80% power (alpha=.05) to demonstrate that misoprostol for menstrual regulation since study imple- the regimen was 90%, ±5%, effective, we calculated that we mentation and perceived barriers to and advantages of its would need to enroll at least 138 women in each phase of use in existing services. All participants provided written the study. This sample size also allowed us to test whether informed consent. Discussions were conducted by a mod- at least 85% of Bangladeshi women enrolled in the study erator trained in qualitative research methods.
were “satisfied” or “very satisfied” with the method.
All focus group discussions were recorded on audiotape and a detailed transcript was prepared after each discus- sion; notes were taken during the focus group discus- The mean age of the women enrolled in the study was 27 sions to supplement the transcripts. The transcripts were years (Table 1). Almost all women were married (99.5%), reviewed by the researchers to identify key themes and and most had attended school, university or madrasa Acceptability and Feasibility of Medication Menstrual Regulation in Bangladesh TABLE 2. Percentage distribution of menstrual regulation
women (included in the 32 surgeries above) eventually re- procedures with medication, by outcome
ceived a surgical evacuation and one woman was lost to follow-up after the second follow-up visit.
As expected, most women (94%) reported that the bleeding experienced after misoprostol administration was similar to or greater than during menses (not shown). Surgical evacuation needed
Substantial minorities reported nausea (37%) or vomit- Increase in uterine size consistent with ongoing ing (24%). About one-fifth of women reported having had mild fever, chills or weakness on the day of misoprostol administration, but in most cases these symptoms did not need treatment. Eight women in the phase-one sites No bleeding after misoprostol administration reported itching of the palms on the day of misoprostol The pregnancy test performed on the stored urine *Excludes 22 women lost to follow-up. †Includes one woman diagnosed with ectopic pregnancy at unscheduled visit after mifepristone- samples determined that most women (93%) who had received mifepristone-misoprostol had been pregnant. The success rate of the subset of women with a positive urine (94%). The mean travel time to the clinic was 33 minutes. pregnancy test (93%) was the same as the success rate for For almost one-quarter of the women, the pregnancy was their first. Slightly more than half of the women had amen- In 45 cases, the urine pregnancy test result was negative. orrhea of no more than six weeks (52%).
The percentage of women with a negative pregnancy test varied widely across clinics (3–18%). Among the women Menstrual Regulation Outcomes
with a negative pregnancy test, slightly more than half Most (93%) of the 629 women with known menstrual (56%) had been amenorrheic for 7–9 weeks since their regulation outcomes evacuated the uterus without surgi- last menstrual period at the time of mifepristone admin- cal intervention (Table 2). There was no significant differ- istration, according to bimanual exam and patient history. ence in the success rate for women who administered the The remaining women (44%) had been amenorrheic for misoprostol at home and those who received it in the clinic Three women with a negative pregnancy test were lost For 46 women, the procedure failed and manual vacuum to follow-up after mifepristone administration. Thirty-eight aspiration was required to complete the procedure (7%). women who had a negative pregnancy test and who re- A manual vacuum aspiration was performed because of an turned to the clinic at or before their follow-up visit were increase in uterine size consistent with an ongoing risk of determined to have had a successful procedure on the ba- pregnancy in 1% of cases and because of incomplete emp- sis of history and clinical exam. Four women with a nega- tying of the uterus in 5% of cases. For 27 women, these tive pregnancy test eventually obtained a surgical evacua- evacuations were performed at the follow-up visit (not tion. Two of these women underwent a manual vacuum shown). In the five remaining cases, the evacuation was aspiration after clinic staff identified an increase in uterine performed at a second follow-up visit after either an ad- size consistent with an ongoing pregnancy at the follow- ditional dose of misoprostol (for two women) or expectant up exam (increased from six to nine and from seven to 10 management (for three). Less than one percent of women weeks’ amenorrhea, respectively). One woman, assessed (0.5%) had a manual vacuum aspiration because of heavy as seven weeks from her last menstrual period at the time bleeding; all of these women presented at the study site of mifepristone administration, returned to the clinic with or a local referral hospital before the scheduled follow-up heavy bleeding one day after misoprostol administration, visit and received a dilation and curettage and blood trans- and a surgical evacuation was performed at that time. One fusion.* Two women (0.3%) requested a surgical evacua- woman assessed as less than six weeks since her last men- tion at or before the follow-up visit. Three (0.5%) returned strual period returned to the clinic two days after misopro- to the clinic before their scheduled follow-up and reported stol administration. She reported no bleeding, and the at- no bleeding after misoprostol administration; in all these tending provider elected to perform a surgical evacuation cases, the attending provider performed a surgical uterine Twenty women were given a second follow-up visit after Protocol Adherence and Home Administration of Misoprostol
the provider identified debris in the uterus at their follow- Almost all women took the mifepristone and misoprostol up visit. An additional 800-mcg buccal dose of misoprostol as indicated and returned as scheduled for their follow- was provided for most of these women. Almost all women up visit (not shown). One woman reported taking the who received the additional medication had a successful procedure. Among the six women who received expectant *Dilation and curettage is the standard practice for management of in-complete abortion at the referral hospitals. Blood transfusions are per- management, two women needed no additional care, three formed when justified by the clinical assessment.
International Perspectives on Sexual and Reproductive Health misoprostol early (i.e., less than 24 hours after taking the TABLE 3. Percentage distribution of women who had a menstrual
mifepristone), and 10 women reported holding the miso- regulation with medication, by selected responses
prostol in their cheeks for fewer than 30 minutes. None of these women required a surgical intervention to complete the menstrual regulation. Few women made unscheduled Satisfaction
calls (14%) or visits (2%) to the clinic.
Women who elected to take the misoprostol at home (N=540) cited several reasons for their choice, including Overall side effects
ease or convenience (62%), a preference for fewer clinic visits (47%) and greater comfort with home administra- tion (33%). Women who were given a choice and who chose to take the misoprostol in the clinic (N=30) did so Bleeding
because they believed that they would receive better care (83%), felt more comfortable (37%), or found it more con- Most (73%) of the women who took the misoprostol at Pain management
home had someone with them at the time of misoprostol administration; for the majority of women, it was their hus- Women were asked about their preference for place of misoprostol administration in the future. Women who *Excludes 22 women lost to follow-up. †Four women did not know and chose to take the misoprostol at home were significantly three reported no bleeding. Note: Percentages may not total 100.0 because more likely to say they would choose to do so in the future than women who chose to receive the prostaglandin in the clinic (home, 93%; clinic, 59%—p<.001).
Acceptability Among Providers
In the focus group discussions, the majority of all types of
Acceptability of Menstrual Regulation with Medication
providers were open to and excited about learning a new Overall, most women (92%) were satisfied with use of pills procedure for menstrual regulation. As one observed: for their menstrual regulation (Table 3). The majority of “This is a nonsurgical method of menstrual regulation both clinic and home users of misoprostol rated their ex- so it will become demandable among clients. The entire perience as satisfactory or very satisfactory. Most women procedure was very much acceptable to both service pro- found the overall side effects associated with the method viders and clients. This is an easy procedure and it has acceptable or very acceptable (90%). About two-thirds of minimum side effects.”—Female medical officer, age 29, phase women (67%) found the bleeding less than or the same as expected. Women’s expectations about bleeding, pain and Yet other providers expressed an initial sense of trepida- pain management differed across sites. Significantly more tion about using medicine rather than manual vacuum as- women at phase-two sites than at the phase-one sites re-ported that the bleeding was more than expected (37% vs. TABLE 4. Percentage of women having a menstrual regula-
tion with medication who reported selected factors as the

26%; p<.001). Most women (70%) enrolled in each phase best and worst features of the procedure
found the pain management provided adequate. However, more women in the phase-one sites than the phase-two sites found the pain medication insufficient (17% vs. 9%; p=.01—not shown). Almost all women reported that they Best
Avoided surgery/anesthesia
would recommend using pills for menstrual regulation to a friend (93%) or would prefer that method if they re- At the follow-up visit, women were asked to report the best and worst features of using pills for menstrual regula- tion (Table 4). The majority of women reported that the best features of the method were that it avoided surgery and anesthesia (64%) and was an easy, quick or simple treatment (55%). The features of menstrual regulation with pills most often identified as the worst were the pain and cramps (44%), anxiety or fear that the method would fail (26%) and bleeding (23%). Twenty percent of women said that there was no worst feature associated with men- *Excludes 22 women lost to follow-up. Note: Multiple answers were possible. Acceptability and Feasibility of Medication Menstrual Regulation in Bangladesh piration. Providers, both doctors and counselors, were ini- at home. We were concerned about how we would solve tially concerned about side effects, and some doctors and and overcome if any physical problem occurred among clinic staff had initial concerns that the medicine would study patients at night.”—Male medical officer, age 51, phase not work properly because the medications were given buccally rather than vaginally, but these concerns were al- Although generally supportive of the introduction of layed after a few successful procedures were performed.
mifepristone-misoprostol into routine menstrual regula- There was clear consensus among all types of provid- tion services, some counselors were concerned about the ers that menstrual regulation with medication avoids implications of the widespread availability of the drugs. As infection and longer-term comorbidities associated with aspiration and other more invasive procedures. The most “The main problem in Bangladesh is no monitoring common justifications given by these providers for the use of pharmacies. There is high chance of misuse of drugs of pills for menstrual regulation were reducing infections if they are available in the local pharmacy. Medical men- and ensuring women’s privacy and dignity. One provider strual regulation should be available in selected facilities, such as [nongovernmental organization] clinics and gov- “In my opinion, this new route on menstrual regulation ernment hospitals—clinics where they can provide coun- will prevent pelvic inflammatory infection and related dis- seling [as well as].emergency complication management eases that may occur [because of] unhygienic manual vacu- services.”—Female counselor age 46, phase one, urban area um aspiration procedures.I think this medical menstrual One counselor doubted that women themselves could regulation procedure will [be a] great benefit to menstrual determine their eligibility for the procedure and under- regulation service provision.”—Female medical officer, age 45, scored that there was a vital role for trained clinicians in However, the introduction of menstrual regulation with “[Duration] of amenorrhea is very vital issue in medi- medication still posed some challenges. Counselors com- cal menstrual regulation procedures. Rural Bangladeshi plained that menstrual regulation with medication required women in most cases [can] not tell accurately about their more counseling than a surgical procedure. As one said: irregular menstrual cycle. [Menstrual regulation with “…it was tough and time-consuming for us to make our medication] should not be available everywhere, without clients understand about the whole procedure of men- proper counseling, monitoring and regulating.”—Female strual regulation with medication and its physical conse- counselor, age 39, phase one, urban area quences.”—Female counselor, age 39, phase one, urban area Counseling needs were also greater for women who had DISCUSSION
previously attempted self-induction using ineffective medi- This project—the first clinical study of the use of cations (such as Gynaecosid) acquired at pharmacies.
mifepristone-misoprostol for menstrual regulation in Ban- Some counselors mentioned difficulties in counseling gladesh—demonstrates the feasibility of introducing the women on buccal administration. (Approximately 1% of method into routine health services in a unique setting. women reported that buccal administration of misoprostol Nearly all women with known outcomes had a successful was the worst feature of menstrual regulation with pills.) menstrual regulation with mifepristone-misoprostol with- Doctors confirmed that a few clients complained of discom- out need for a surgical evacuation. Women also reported a fort and abrasions in the mouth, and that approximately high level of satisfaction with the method.
3% of women had not held the pills in their cheeks for 30 The menstrual regulation success rate of 93% observed minutes as instructed. Several doctors explained that wom- in this study is comparable to international experience en had not complied with these directions because they did with this regimen at gestational ages of 63 days or less not like the taste of the misoprostol or were experiencing since the last menstrual period, which has shown success the morning sickness associated with early pregnancy.
rates of 93–98%.15–17,19,20 Our study demonstrates that the Some providers, including doctors, counselors and mifepristone-misoprostol regimen can be provided with paramedics, were anxious about waiting the 14 days un- existing staff and equipment in menstrual regulation ser- til the follow-up visit to learn the results of the procedure. vices in Bangladesh. Midlevel providers assisted in the eli- They said that an important challenge of the method was gibility screening and postabortion follow-up, especially in the loss of control over the final outcome. They observed the phase-two sites. Studies have shown that nonphysician that use of pills for menstrual regulation is not solely in the providers can effectively and safely offer the method.21 The control of service providers, but depends on the client’s medication regimen was also provided safely and effective- ability to manage the procedure. This contributed to the ly without the use of routine ultrasound for assessment of doctor’s overall anxiety about the outcome of the proce- eligibility or menstrual regulation outcome. Although all women were asked to provide a phone number for follow- “During the study, we were anxious about the response up purposes, this did not inhibit study enrollment. On- of the study patients. We were always anxious to hear any going research is examining the use of phone follow-up complication like bleeding, painful bleeding, spotting or or a self-assessment at home in lieu of a routine in-clinic any other problem [that] might occur after taking medicine visit. Such simplified protocols may be particularly advan- International Perspectives on Sexual and Reproductive Health tageous in settings where travel to the health facility may Still, in this setting, it is possible that some women who did not have an ongoing pregnancy (and were experienc- Prior research has shown that women can safely and ef- ing amenorrhea for other reasons) received mifepristone- fectively administer misoprostol at home.22 Our study reaf- misoprostol for menstrual regulation. There are no adverse firms this finding and, in fact, when given the choice, most effects associated with taking mifepristone and misopros- women in the study chose to administer the misoprostol at tol when not pregnant and, arguably, the ingestion of these home. The qualitative data from our study suggest, howev- medications is considerably safer than the alternative—the er, that women managing their menstrual regulation pro- potential risk of infection associated with an unnecessary cedure at home initially increased provider anxiety. This is invasive evacuation of the uterus. However, the manage- a common experience in other settings with the introduc- ment of such cases is still of concern. While mifepristone- tion of a novel method. However, provider anxiety often misoprostol may help reduce the risk of medically unnec- diminishes with increased confidence and experience with essary surgical evacuations, it may not do so completely. One woman with amenorrhea of six weeks or less under- Our study findings also suggest that acceptability went a surgical evacuation on day five after she reported among providers may increase over time as providers be- no bleeding following misoprostol administration. (Two come more comfortable with providing menstrual regu- women with positive pregnancy tests also received a surgi- lation using medication. The introduction of medication cal evacuation when they reported no bleeding at an un- menstrual regulation may require an adjustment in tasks, scheduled visit prior to follow-up.) Especially in settings especially an increase in the need to provide informa- where pregnancy status is not confirmed with a urine preg- tion and counseling. The development of standardized nancy test or ultrasound, providers should be advised to counseling and informational materials for providers and complete a physical exam at the scheduled follow-up visit women may help smooth this adjustment. Such materials before performing any additional interventions. Any wide- may aid providers in counseling and help to allay provider spread introduction of mifepristone-misoprostol should concerns about women’s ability to manage their care in- be accompanied by training, monitoring and evaluation, dependently. These materials may also be a useful means and other quality control measures to ensure appropriate of educating women and their networks about menstrual and effective eligibility assessment and confirmation of fi- Attesting to the success of the national menstrual regu- An interesting finding that emerged from the focus lation program, women in Bangladesh often present early group discussions was the observation about the need to for menstrual regulation services. Approximately half of ensure quality and appropriate use if the drug regimen be- the women in the study had been amenorrheic for six comes widely available in Bangladesh. There is little regu- weeks or less. However, without verification of pregnancy lation of pharmacies in Bangladesh and many medicines status with a urine pregnancy test (the standard clinical are sold over the counter without prescription.24 Pharma- practice for eligibility assessment), there is the risk that cies are allowed to sell oral contraceptives and emergency some of these women may have been experiencing amen- contraception without prescription. Several focus group orrhea for reasons other than pregnancy. Our study sug- participants suggested that menstrual regulation with gests that the current practice of bimanual exam and pa- medication should be made available in selected locations tient history is relatively good at identifying women with where the necessary counseling, referral and follow-up can ongoing pregnancy. We do not have comparative data be ensured. The concerns raised about the potential im- for routine menstrual regulation services so we cannot pact of widespread availability of the drugs in pharmacies speculate if this reflects the normal patient population in reflected the recognition of the importance of increased these clinics. We also cannot confirm whether the women counseling for menstrual regulation with medication.
with a negative pregnancy test were indeed not pregnant. The findings of the study should be assessed while con- The eligibility assessment did find that slightly fewer than sidering the following limitation. The study sites were lo- half of these women were very early in pregnancy (i.e., six cated in urban or periurban settings, which have relatively weeks or less since their last menstrual period). However, good infrastructure when compared with rural areas of the for most women who returned for follow-up, the clinical country. The findings may thus not be generalizeable to re- findings and history appear consistent with the expected gions of Bangladesh where transportation services and re- course of treatment for a pregnant woman (i.e., a history of ferral networks are less developed. Future research should bleeding similar to or greater than menses and evidence explore the use of mifepristone-misoprostol protocols in of a decrease in uterine size consistent with a state of non- public-sector facilities where staff and resources may be pregnancy). Also, two-thirds of the samples with negative test results came from three clinics (8–11 cases each; 30 of the 45 negative samples). In those clinics, most of the REFERENCES
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7. Akhter HH et al., A Study to Assess the Determinants and Consequences
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Association for Prevention of Septic Abortion, 1990.
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do servicios de regulación menstrual, y para quienes habían tices in Bangladesh: an unrecognized form of contraception, Asia- transcurrido 63 días o menos desde su última menstruación, Pacific Population Journal, 2004, 19(4):75–99.
recibieron 200 mg de mifepristona seguida, después de 24 ho- 11. Johnston HB et al., Health system costs of menstrual regulation
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determinar la experiencia y satisfacción de las mujeres con <http://gynuity.org/downloads/map_mife_en.pdf>, accessed Dec. el procedimiento, el resultado de la regulación menstrual, así como los recursos humanos y físicos necesarios para proveer el 13. Kulier R et al., Medical methods for first trimester abor-
método. Se llevaron a cabo discusiones de grupo focal con un tion, Cochrane Database of Systematic Reviews, 2011, Issue 11, No. grupo formado por una muestra intencional de proveedores de servicios en cada institución con el fin de comprender sus 14. WHO, Safe Abortion Technical and Policy Guidance for Health
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actitudes acerca de la introducción de la regulación menstrual 15. Middleton T et al., Randomized trial of mifepristone and buccal
or vaginal misoprostol for abortion through 56 days of last menstru- Resultados: La mayoría (93%) de las mujeres con resultados
al period, Contraception, 2005, 72(5):328–332.
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pristone and buccal misoprostol through 59 gestational days,
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ción a los requerimientos adicionales de consejería y la falta de 18. Borgatta L et al., Instituting medical abortion services: changes
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RÉSUMÉ
21. Warriner IK et al., Can midlevel health-care providers admin-
Contexte: Chaque année, plus de 700 mille femmes font ap-
ister early medical abortion as safely and effectively as doctors? A randomised controlled equivalence trial in Nepal, Lancet, 2011, pel à la régulation menstruelle, ou évacuation utérine par as- piration sous vide; bien davantage ont recours à l’avortement International Perspectives on Sexual and Reproductive Health non médicalisé. L’approche médicamenteuse de l’évacuation
utérine pourrait accroître l’accès des femmes à des services de
régulation menstruelle sans risques et faire baisser les hauts
niveaux de morbidité imputables à l’avortement et à la régu-
lation menstruelle au Bangladesh.
Méthodes: Dans 10 établissements du Bangladesh, 651
femmes consentantes en quête de services de régulation mens-
truelle et dont les dernières règles remontaient à un maximum
de 63 jours ont reçu 200 mg de mifépristone suivis, 24 heures
plus tard, de 800 mcg de misoprostol, administrés par voie
orale à domicile ou à la clinique. Des données prospectives ont
été collectées pour déterminer l’expérience et la satisfaction des
femmes à l’égard de la procédure, l’issue de la régulation mens-
truelle et les ressources humaines et matérielles nécessaires à
l’offre de la méthode. Des discussions de groupe ont été menées
avec un échantillon délibéré de prestataires de chaque site, afin
de cerner leurs attitudes concernant l’introduction de la régu-
lation menstruelle médicamenteuse.
Résultats: La majorité des femmes (93%) aux issues de régu-
lation menstruelle connues ont obtenu une évacuation utérine
sans intervention chirurgicale. Dans l’ensemble, la plupart
des femmes (92%) étaient satisfaites de leur régulation mens-
truelle par voie médicamenteuse orale. Les prestataires ont dû
faire face aux défis et inquiétudes initiaux, concernant notam-
ment les exigences de conseil accrues et l’absence de contrôle
sur l’issue finale, mais ils se sont montrés plus confiants après
utilisation réussie du programme médicamenteux.
Conclusions: La combinaison de mifépristone-misoprostol
peut être proposée sans risques au sein des services de régula-
tion menstruelle existants des milieux urbains et périurbains
du Bangladesh. Elle bénéficie d’un haut degré d’acceptabilité
parmi les femmes. Les inquiétudes initiales des prestataires
diminuent à mesure qu’ils acquièrent l’expérience de la mé-
thode.

Acknowledgments
This research protocol and the preparation of this manuscript were funded by a grant from an anonymous donor to Gynuity Health Projects. icddr,b also gratefully acknowledges the following donors that provide unrestricted support: Australian Agency for Inter-national Development; Government of the People’s Republic of Bangladesh; Canadian International Development Agency; Em-bassy of the Kingdom of the Netherlands; Swedish International Development Cooperation Agency; and the Department for Inter-national Development, UK. The Concept Foundation donated the mifepristone-misoprostol but did not contribute to the design or analysis of the study. Square Pharmaceuticals, Ltd. donated the analgesics to icddr,b for the study but did not contribute to the design or analysis of the study. Author contact: [email protected]

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