Self-managed medication abortion outcomes: results from a prospective study

Self-managed medication abortion outcomes: results from a prospective study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Help Center Sign In Submit a Preprint Cite Share Download PDF Research Self-managed medication abortion outcomes: results from a prospective study Heidi Moseson, Ruvani Jayaweera, Sarah Raifman, Brianna Keefe-Oates, and 8 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-31998/v2 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 27 Oct, 2020 Read the published version in Reproductive Health → Version 2 posted 9 You are reading this latest preprint version Show more versions Abstract Background: To evaluate the feasibility of conducting a prospective study to measure self-managed medication abortion outcomes, and to collect preliminary data on safety and effectiveness of self-managed medication abortion, we recruited callers to accompaniment groups (volunteer networks that provide counselling through the out-of-clinic medication abortion process by trained counselors over the phone or in-person). Methods: In 2019, we enrolled callers to three abortion accompaniment groups in three countries into a prospective study on the safety and effectiveness of self-managed medication abortion with accompaniment support. Participants completed up to five interview-administered questionnaires from baseline through six-weeks after taking the pills. Primary outcomes included: (1) the number of participants enrolled in a 30-day period, (2) the proportion that had a complete abortion; and (3) the proportion who experienced any warning signs of potential or actual complications. Results: Over the 30-day recruitment period, we enrolled 227 participants (95% of those invited), and retained 204 participants (90%) for at least one study follow-up visit. At the one-week follow-up, two participants (1%) reported a miscarriage prior to taking the pills, and 202 participants (89% of those enrolled and 99% of those who participated in the one-week survey) had obtained and taken the medications. Three weeks after taking the medications, 192 (95%) participants reported feeling that their abortion was complete. Three (1.5%) received a surgical intervention, two (1%) received antibiotics, and five (3%) other medications. Participants did not report any major adverse events. Conclusion: These results establish the feasibility of conducting prospective studies of self-managed medication abortion in legally restrictive settings. Further, the high effectiveness of self-managed medication abortion with accompaniment support reported here is consistent with high levels of effectiveness reported in prior studies. Trial Registration: ISRCTN95769543 Sexual & Reproductive Medicine abortion accompaniment Africa mifepristone misoprostol self-managed abortion South America Southeast Asia Figures Figure 1 Plain English Summary Self-managed abortion describes anything someone does to end a pregnancy without help or supervision from a doctor, nurse, or other clinicians. People self-manage abortions for many reasons—sometimes because they cannot access abortion in a clinic or hospital because abortion is illegal in their area, or the nearest clinic is too far away, or they do not have the money to pay for one; other times, people choose to self-manage their abortions because it is more private, and can be done from their own home. To determine whether it was possible to recruit people into a research study about experiences with a stigmatized and legally restricted experience (self-managed abortion), and also to evaluate hypotheses about the effectiveness of self-managed medication abortion, we conducted a pilot study. In this pilot study, we recruited people who contacted a safe abortion hotline (accompaniment group) looking for information about self-managed abortion, and we followed them forward in time to measure what happened. In one month, we recruited 227 people across three countries, and followed them for up to six weeks to measure whether they obtained medication abortion pills, if they took them, and if their abortion was successful. We found that people were willing to participate in a study about this topic, and that almost everyone obtained medication (89%). Among those that took medication, almost everyone (95%) had a complete abortion. These results are encouraging for future research on this topic, and suggest that self-managed abortion with pills is effective and safe. Background Around the world, people face structural barriers and legal restrictions that prevent access to high-quality abortion services. Even when abortion services are available in facility settings, some people prefer out-of-clinic abortion care for reasons related to privacy, autonomy, and concerns such as stigma, mistreatment, and high cost.(1, 2) The reasons that people attempt to self-manage abortion—defined here as ending one’s own pregnancy outside of a formal health-care setting—and the means by which they do so, vary widely by setting.(1, 2) The incidence of self-managed abortion is not well studied; estimates suggest that approximately 45 percent of abortions worldwide in 2010–2014 took place outside of a health facility(3) - and in some settings, the proportion may be closer to 70 or 80 percent.(3, 4) Given the barriers to abortion access in clinical settings, those in need of abortion care are increasingly obtaining mifepristone and misoprostol, World Health Organization (WHO) recommended medications for abortion,(5) through informal sector routes including online services, pharmacies, hotlines, and drug sellers.(6–10) There is a growing body of literature from around the world indicating that when individuals have access to information about how to obtain the pills, how to take the pills, how to assess for completion, and warning signs that may indicate potential complications, the practice of self-managed medication abortion is safe and the experience satisfactory.(8, 9, 11–15) Much of the published literature has focused specifically on the experiences of self-managed medication abortion with telemedicine support from online websites that provide access to pills as well as information on how to use them via email communication; these studies report safe and effective abortion experiences.(2, 8, 12, 13, 16–18) Beyond online websites, people obtain information, medications, and support to self-manage their abortions in a variety of other ways as well. One emerging model is abortion accompaniment, where trained volunteers provide WHO-recommended evidence-based information about medication abortion, as well as physical and emotional support and person-centered care throughout the medication abortion process, over the phone or in person, outside of the formal health care system.(15, 19–22) This non-clinic based model of counselor-supported self-managed medication abortion care has come to be known as the “accompaniment model,” as people are virtually “accompanied” through the medication abortion process. Approximately fifty accompaniment groups are in operation around the world, providing support and information about self-managed medication abortion. However, despite the increasing number of abortion accompaniment groups worldwide, little research has documented the safety and effectiveness of the abortion accompaniment model. Among accompaniment clients, we are aware of only three studies that have reported on outcomes of self-managed medication abortion; all found high levels of abortion completion, and few complications.(15, 22, 23) Of the data that do exist, however, there are important limitations– including a heavy reliance on retrospective records that were not collected for the purposes of research. Evidence suggests that a high proportion of abortions occur outside of the health care system and changing global dynamics may continue to shift more abortions outside of the healthcare system.(24) Well-designed, rigorously-collected data are needed to assess the safety and effectiveness of medication abortion administered completely outside of the formal healthcare system—such as the accompaniment model—to contribute to our understanding of de-medicalized models of abortion care.(25) To address this gap, we designed a pilot prospective observationalstudy of the effectiveness and safety of self-managed medication abortion with accompaniment group support in three countries. We conducted the pilot study to inform the design and implementation of a larger, non-inferiority trial to prospectively evaluate the effectiveness of self-managed medication abortion with accompaniment group support as compared to the effectiveness of medication abortion in a clinical setting. The primary aims of the pilot study were to (1) assess the feasibility of implementing a prospective study to recruit and follow callers to abortion accompaniment groups; and (2) evaluate hypotheses about the effectiveness and experiences of self-managed abortion under this model of care. While these data come from a pilot study, so do not represent results that are powered to make definitive statements about safety, these data provide foundational evidence for other studies in development on self-managed abortion, particularly as we find ourselves in a moment of history where delivery of healthcare services by the formal sector will require innovation, and where healthcare infrastructures around the globe will be challenged in unknowable ways.(26, 27) All of these factors could lead to an increase in incidence of and demand for self-managed abortion. These pilot study data represent some of the first ever prospective data on the effectiveness of self-managed abortion,(2, 15, 22, 23) and provide insight into ways that healthcare systems could adapt to support those who choose to or need to self-manage abortions. Methods Study setting A research consortium that includes researchers, advocates, and accompaniment providers collaboratively designed this study to ensure that it reflected the priorities, experiences, and preferences of people who self-manage abortions with medication. Study investigators invited individual consortium members (included as co-authors) to participate based on their expertise in self-managed medication abortion and accompaniment models in a range of legal and cultural settings, to ensure the design of a study that reflected the lived experiences of people who self-manage, the accompaniers who support them, and contexts similar to those in which the study will take place. The overall study protocol was reviewed and approved by the Allendale Investigational Review Board, by a local IRB as appropriate, and by a study-specific Data Monitoring and Oversight Committee (DMOC) with medication abortion experts from each study country, and a chair with research expertise in clinical medication abortion effectiveness studies. Data for this study were collected in three countries located in South America, Southeast Asia, and West Africa. The names of the abortion accompaniment groups and their home countries are blinded due to safety and legal concerns for those managing the hotlines, and the hotline callers. The three included accompaniment groups were selected to represent variation in legal and sociocultural contexts with respect to abortion, and because they each had identified research as an important mechanism for informing policy and practice. The three accompaniment groups vary somewhat in their approach, but each involves an initial screening conversation with the pregnant person that takes place via secure messaging or a telephone call. During this screening conversation, the accompaniment counselor confirms that the person is seeking abortion for themselves, that the person is not being coerced, and that they have no known contraindications to medication abortion. Further, the counselor assesses the gestational age of the pregnancy based on either the date of last menstrual period as reported by the caller, or an independently acquired ultrasound. For callers who obtained an ultrasound, gestational age is based on the ultrasound dating. After confirming eligibility for medication abortion, the counselors then provide step-by-step instructions for how to use medication to induce abortion based on current WHO protocols (Appendix 1; of note, some of these regimens include off-label use of mifepristone and misoprostol), information on obtaining the medications, and highly detailed guidance on assessing abortion completion and potential warning signs of complications, as well as when formal healthcare may be needed. Accompaniment group staff are in frequent contact with callers during the medication abortion process to answer questions and provide support to the person self-managing an abortion. The accompaniment group in South America provides information primarily on a combined mifepristone and misoprostol regimen, while the groups in Southeast Asia and West Africa counsel on both a combined and misoprostol alone regimen, depending on which pills the caller is able to obtain. Study design and data collection This pilot study was a prospective, observational study in which people who contacted an accompaniment group for information and support with self-managing a medication abortion were enrolled and followed for up to six weeks to assess their abortion outcome and experiences. As one of the primary aims of the pilot study was to assess feasibility, sample size was flexibly set to the number of people counselors could successfully recruit in 30 days. Pilot study enrollment at each site was open for approximately 30 days in April and May of 2019. Participants were followed up to six weeks, with most followed for three-weeks. We conducted the last follow-up interview in June 2019. Survey instruments were professionally translated into local languages as needed for each site, and were then pre-tested with four to five cognitive interviews in each country (13 total), and then updated accordingly. During the initial counseling conversation, accompaniment counselors assessed all callers to the accompaniment group for eligibility for study participation during the 30 days. Eligibility criteria included: (1) having contacted the accompaniment group seeking information about induced abortion for their own pregnancy; (2) being at least 13 years of age; (3) being able to give informed consent; (4) being able to speak a local language; (5) meeting hotline eligibility criteria for starting the medication abortion process (i.e. no contraindications to medication abortion; Appendix 1); and (6) starting a new medication abortion process. Callers were excluded from the study if they (1) had taken medications in an attempt to end the current pregnancy within the 30 days prior to contacting the hotline; (2) were experiencing ongoing symptoms of spontaneous or induced abortion (bleeding, cramping) at the time of contacting the hotline; (3) had a known ectopic pregnancy; (4) did not want to share their contact information with study staff; (5) did not want to be contacted again by the hotline or by study staff; or (6) were not willing to comply with study procedures. Callers of any gestational age were eligible to participate in the study. Eligible participants were invited to participate by the accompaniment counselor at the end of the first counseling conversation. Participants who expressed interest proceeded through an informed consent conversation with detailed information about study participation, risks and benefits. All participants who gave their informed consent to participate were enrolled into the pilot study. Immediately after enrollment, each participant answered baseline questions about their current pregnancy, reproductive history, contact information, and select sociodemographic characteristics. Follow-up surveys were completed by trained study coordinators at each site, recruited from trusted partner organizations, and employed full time on the research study for the duration of recruitment and data collection at each site. The first follow-up survey was conducted over the phone (voice-call or secure messaging) one-week after the pills were scheduled to be taken. This one-week follow-up inquired about obtaining the medications, medication type, detailed information on timing and route of administration, pain, bleeding and cramping during the abortion, and self-reported assessment of abortion completion. Two weeks after the first follow-up, approximately three-weeks after the medication was taken, study coordinators contacted participants for a second-follow-up that included questions about any additional doses taken, warning signs of complications, completion of abortion, healthcare seeking, disclosure of the abortion, satisfaction with the accompaniment group, and emotions about the experience. Participants who reported they were no longer planning to take the pills, were asked why, and no further follow-up was conducted. Participants received an incentive in the form of phone credit for each survey completed. Study coordinators entered all survey data into a secure, online platform. Study measures Effectiveness of self-managed medication abortion. The primary outcome of interest was effectiveness of self-managed medication abortion with accompaniment group support, defined as complete abortion at last study contact, without surgical intervention at any point. We classified an abortion process as “effective” if the participant responded “yes” to the question, “Do you feel that your abortion process is complete?” and did not report a surgical intervention when asked “At the health facility, what treatment did you receive?” (among participants who reported seeking medical care at a health facility during or after their abortion process). Participants also reported why they felt their abortion was complete, and if they had an ultrasound, or had taken a pregnancy test to confirm completion. We also calculated a secondary, more inclusive definition of “effective”– defined as a participant who was no longer pregnant at the end of follow-up, regardless of whether surgical intervention took place or not. Complications. Warning signs of potential complications of self-managed medication abortion were assessed by asking participants to self-report any occurrence of (1) heavy bleeding that soaked more than two pads per hour for more than two hours, (2) pain that did not go away with the use of painkillers, (3) fever that lasted for over 24 hours, and (4) foul smelling vaginal discharge. Participants were also asked about whether they experienced side effects at any point in the abortion process, including fever, diarrhea, nausea, vomiting, or dizziness, as well as signs of potential allergic reaction, including itchiness, difficulty breathing, sweaty hands, or face numbness. Complications were identified based on participant self-report and receipt of treatment. Those who sought care at a facility at any point in the process were asked why they sought care and what treatment they received (surgical intervention, antibiotics, other medications, or observation). Analysis We summarized baseline sociodemographic characteristics and data on reproductive history for the study population through measures of frequency and central tendency. We then calculated the proportion of participants who successfully obtained medications for abortion and used the medications to self-manage abortion at the one-week follow-up, and described the medication abortion experience stratified by type of medication regimen. Finally, we calculated the proportion of participants who completed the abortion, the proportion who sought care, and the proportion that reported warning signs of complications by the three-week follow-up. We conducted all analyses in Stata version 15.0. We double-entered study data for 46 participants (20%) to check for any systematic errors in data entry. We then conducted a sensitivity analysis to re-estimate the primary outcome under the conservative assumption that all those lost to follow-up had incomplete abortions. Results Sample characteristics Study recruiters screened 346 callers for eligibility during the 30-day recruitment period (Figure 1). Seventy-four callers (21%) were ineligible due to calling about something other than medication abortion, having already begun a medication abortion process, being outside of the hotline gestational age range, being undecided about abortion, or unwilling to receive follow-up. During the initial counseling conversation prior to starting a medication abortion process, one participant described symptoms of a possible ectopic pregnancy. Upon hearing these symptoms, the counselor immediately referred the participant to a health facility for an ultrasound, where an ectopic pregnancy was confirmed, and the participant received appropriate and effective medical care. The study coordinator consequently classified this person as ineligible for study follow-up. Aside from this person, the study team enrolled 227 participants across the three sites. Two-hundred and four participants (90%) completed the one-week survey, and 175 (77%) completed the three-week survey. At baseline, the majority of participants (75%) were less than 30 years of age, and 84% had at least some secondary education (Table 1). The majority of participants identified the pregnancy with a pregnancy test (89%), followed most closely by ultrasound (19%), and/or a late or missed menstrual period (15%). Only one participant (0.4%) reported a pregnancy that was not confirmed by a pregnancy test or ultrasound. At the time of enrollment, 68% of participants had a pregnancy of less than eight weeks gestation, 21% between 8–9 weeks, 9% between 10–12 weeks, and 2% between 13 and 17 weeks. Only one study site measured method of gestational age ascertainment; most participants at this site assessed their gestational age based on date of the last menstrual period (79%). Ten percent of participants reported a prior attempt to end the current pregnancy, before contacting the accompaniment group. Prior attempts to end the pregnancy included ingesting herbs or using emergency contraception pills with intent to terminate. Table 1 Sociodemographic characteristics of 227 callers to accompaniment groups pursuing self-managed medication abortion in three countries in South America, Southeast Asia, and West Africa. Total (n=227) n % Participant age (years) Secondary 120 52.9 Missing 3 1.3 Pregnancy Characteristics n % Ascertainment of Pregnancy (select all) Pregnancy Test 202 89.0 Ultrasound 44 19.4 Late/Missed Period 34 15.0 Pregnancy Symptoms 28 12.3 Other 7 3.1 Gestational Age <8 weeks 154 67.8 8 or 9 weeks 47 20.7 10-12 weeks 20 8.8 13-17 weeks 4 1.8 Missing 2 0.9 Use of medication abortion pills At the one-week follow-up, 202 participants (90% of those enrolled and 99% of those who participated in the one-week survey) had obtained the medication - just under half of these 202 participants reported obtaining the medication from a pharmacy (n = 97, 49%). Two participants (1%) reported having had a miscarriage prior to taking the medications, and did not complete subsequent follow-ups; and 23 participants (10%) were lost to follow-up at one week. All participants who obtained the medications and completed the one-week survey (n = 202) reported taking them by the one-week follow-up (Table 2). Slightly over half of participants at the one-week follow-up (n = 107, 53%) reported taking mifepristone and misoprostol in combination, 47% (n = 94) reported taking misoprostol alone, and one participant did not report medication used. Participants most commonly utilized sublingual administration for misoprostol (n = 339 of 370 doses, 92%). Table 2 Medication abortion pills sourcing and utilization at one-week follow-up among 204 callers to accompaniment groups pursuing self-managed medication abortion in three countries in South America, Southeast Asia, and West Africa. Medication characteristics One-week follow-up (n=204) Have you gotten the pills yet? n=204 % Yes 202 99.0 Yes, but did not take b/c had a miscarriage 1 0.5 No, had a miscarriage prior to obtaining 1 0.5 How were the pills packaged? n=202 % Blister pack 90 44.6 Loose pills 90 44.6 Missing 22 10.9 Have you taken the pills yet? n=202 % Yes 202 100.0 Medication regimen n=202 Mifepristone and misoprostol 107 53.0 Misoprostol alone 94 46.5 Missing 1 0.5 Misoprostol route of administration n=370 % Sublingual 339 91.6 Buccal 15 4.1 Vaginal 12 3.2 Oral 2 0.5 Missing 2 0.5 Completion of self-managed medication abortion Three weeks after taking the medications, 95% of participants (n = 192) who took medications reported feeling that their abortion was complete at their last follow-up, and 94% (n = 189) felt their abortion was complete and had not reported surgical intervention (Table 3). Among the participants who had a complete abortion, three (1.5%) reported a surgical intervention to evacuate the uterus. Seven participants (3.5%) reported being “not sure” that their abortion was complete; four of these participants reported having felt the products of conception expel, but reported being unsure about the abortion completion because they had not yet taken a pregnancy test or had an ultrasound to confirm they were no longer pregnant. Another participant was unsure because she reported still feeling some “pregnancy symptoms,” and another was unsure because of a lack of confidence in medication abortion versus the certainty of surgical abortion. Three participants (1.5%) reported that they did not feel that their abortion was complete. One was still bleeding, and thus felt the process was not complete. The other two sought care in the formal healthcare system and were told by healthcare providers that their abortions were incomplete; however, healthcare providers did not intervene surgically or medically. Completion by gestational age is included in Appendix 2. We have no data on whether medications were taken or any subsequent outcomes for 23 participants (10%) who did not complete any post-enrollment follow-up. In a sensitivity analysis, we assumed that all of these lost participants (n = 23) obtained the medications and took them, but none had a complete abortion; under this assumption, the estimated proportion with a complete abortion at three-weeks post enrollment would then fall to 85%, or 192 out of 225 participants (excluding the two who miscarried prior to taking the pills). Physical experience of self-managed medication abortion Across both medication regimens, nearly all participants experienced bleeding and cramping during the abortion process (Table 3). The majority of participants reported using at least one technique to manage the pain (asked at one week in Southeast Asia, and at two weeks in South America and West Africa): most commonly pain medications (n = 118 of 181, 65%), followed by methods of distraction, such as listening to music or watching television (n = 18, 10%) (Table 4). Participants also reported several side effects. Participants reported nausea most commonly (n = 111, 61%), followed by fever/chills (n = 110, 60%), diarrhea (n = 90, 50%), vomiting (n = 61, 34%), and dizziness (n = 7, 4%). Few participants reported signs of an allergic reaction to the medications. Table 3 Outcomes and experiences of self-managed medication abortion with accompaniment support among 202 participants who took the medications. Medication regimen is missing for one participant. Total (n=202) Mife + Miso regimen (n=107) Miso only regimen (n=94) Did you experience any bleeding?* n % n % n % Yes 196 97.0 105 98.1 90 95.7 No 1 0.5 0 0.0 1 1.1 Missing 5 2.5 2 1.9 3 3.2 Did you experience any cramping/contractions?* Yes 192 95.0 99 92.5 92 97.9 No 7 3.5 7 6.5 0 0.0 Missing 3 1.5 1 0.9 2 2.1 Abortion outcome Reported feeling abortion was complete 192 95.1 103 96.3 88 93.6 Reported feeling abortion was complete and no surgical intervention 189 93.6 101 94.4 87 92.6 Reported feeling unsure if abortion was complete** 7 3.5 2 1.9 5 5.3 Reported feeling that abortion was NOT complete*** 3 1.5 2 1.9 1 1.1 If complete, how did you know? (select all) n=192 n=103 n=88 Saw products of conception 91 47.4 57 55.3 34 38.6 Negative pregnancy test 36 18.8 9 8.7 27 30.7 Pregnancy symptoms ended 97 50.5 47 45.6 50 56.8 Ultrasound confirmed completion 33 17.2 10 9.7 23 26.1 Clinician told me 8 4.2 8 7.8 0 0.0 Accompanier/counselor told me 30 15.6 30 29.1 0 0.0 * Reported at one-week follow-up ** The most common reason given for being “not sure” that an abortion was complete was because the participant had not yet taken a pregnancy test to confirm completion, despite having felt the products of conception expel. *** One participant who said their abortion was not complete was still bleeding at the last follow-up. Safety of self-managed medication abortion In the three weeks following medication abortion, some participants reported warning signs of potential complications (Table 4), most commonly foul smelling discharge (n = 9, 5%), bleeding that soaked more than two sanitary pads per hour for more than two hours (n = 8, 4%), pain that did not go away (n = 7, 4%), and fever that lasted more than 24 hours (n = 1, 0.6%). Disproportionately more participants, however, reported seeking care during or after the self-managed medication abortion process (n = 60, 33%). Most of the participants that sought formal health care (n = 40 of 60, 67%) did so to confirm completion of the abortion, commonly at diagnostic laboratories rather than at a clinic or hospital. Of the participants who took medications, five (3%) received other medications, three (1.5%) received a surgical intervention (manual vacuum aspiration or dilation and curettage), and two (1%) received antibiotics. No major adverse events were reported, such as hysterectomy or death. Table 5 Physical experiences of self-managed medication abortion, as well as health care seeking among callers pursuing self-managed medication abortion with accompaniment support. Data reported at one week and three-week follow-up in Southeast Asia, and at three week follow-up only in South America and West Africa, hence the denominator of 181. Total n % Side effects n=181 Nausea 111 61.3 Any fever, for any duration 110 60.1 Diarrhea 90 49.7 Vomiting 61 33.7 Dizziness 7 3.9 Signs of potential allergic reaction n=181 Itchiness 15 8.3 Difficulty breathing 2 1.1 Sweaty hands 1 0.6 Face numbness 1 0.6 Warning signs of complications n=181 Foul smelling discharge 9 5.0 Bleeding 2+ hours 8 4.4 Pain that doesn't go away 7 4.1 Fever over 24 hours 1 0.6 Pain management method n=181 Pain medications 118 65.2 Distraction 18 9.9 Massage/hot water 10 5.5 Sought health care at a facility for any reason n=181 Yes 60 33.1 No 114 63.0 Missing 7 3.9 Reason for seeking care n=60 Confirm abortion 40 66.7 Symptoms/side effects (pain, fainting, bleeding) 5 8.3 Missing 15 25.0 Treatment received (select all) n=60 Observation/confirmation of termination 50 83.3 Medications/tablets 5 8.3 Surgical intervention 3 5.0 Antibiotics 2 3.3 Disclosed to provider about abortion? n=60 Yes 18 30.0 No 39 65.0 Missing 3 5.0 Discussion Findings from this pilot study indicate that recruitment and prospective follow-up of callers to abortion accompaniment groups is feasible, and provide preliminary evidence that self-managed medication abortion with accompaniment group support is an effective model of abortion care. During approximately one month of follow-up, across three diverse settings, the majority of pilot study participants obtained medication abortion pills, took the medication abortion pills following information provided by accompaniment group counselors, and completed their abortion without the need for surgical intervention, and without major complications or other safety events. The findings presented here build on a robust body of evidence that points to a similar conclusion: self-managed medication abortion with accurate information on how to use the pills can be effective and safe.(2, 7, 8, 11, 14, 15, 22, 28–31) This pilot study has demonstrated that research conducted in close partnership with groups that provide abortion accompaniment is a promising avenue to improve understanding of self-managed abortion. These groups facilitate the efficient identification of people self-managing their abortions (a group that has been historically difficult to identify and recruit for studies(25)) and enables deeper insight into these experiences given the naturally consistent interaction that often occurs between counselors and callers throughout the accompaniment process. However, conducting rigorous evaluations of this de-medicalized model of care has a unique set of challenges, primarily the reliance of self-report for gestational age assessment and measurement of all primary outcomes. This approach reflects a high degree of confidence and trust in participant ability to self-assess study outcomes, as well as limitations imposed by legal restrictions in each country. Additionally, research from clinical settings has demonstrated the accuracy of report of last menstrual period as compared to ultrasound assessment(32–36): the largest study to date found that only 3.3% of 4,257 medication abortion clients from ten clinics across the United States had a gestational age beyond 63 days by ultrasound assessment but a gestational age below 63 days based on last menstrual period.(32) Even for those who may be off in their gestational age assessments, research has demonstrated that early medication abortion remains safe and highly acceptable without screening ultrasound.(35) Indeed, WHO technical guidance does not require ultrasound confirmation of gestational age for early medication abortion,(5) and last menstrual period is the typical assessment for pregnancy dating in many study contexts.(37, 38) Furthermore, studies assessing the effectiveness of telemedicine for abortion, home administration of misoprostol, and telephone follow-up after a clinic-based medication abortion have demonstrated the reliability of self-report of completion based on structured criteria.(39, 40) Our study also suffered from loss-to-follow-up. To understand the extent to which this could have biased results, we conducted a sensitivity analysis in which we made the most conservative assumption that all participants who were lost-to-follow-up had a failed abortion. Under this conservative assumption, the overall effectiveness of self-managed abortion with accompaniment support is 85% - which is similar to the efficacy of misoprostol alone demonstrated in clinical trials.(41) Additionally, the proportion lost to follow-up is comparable to typical loss to follow-up among medication abortion clients in clinic visits in the United States.(42) However, given the restrictive legal and social environments in which the study took place, the accompaniment groups report that individuals who are lost to follow-up tend to be those with successful abortions who need no additional support, while those in need of information on accessing formal health care, or who experience a failed abortion, are more likely to stay in contact as they are often the only source of care or information for these people. Accompaniment groups report very few instances of complications being reported more than one month after a person takes the pills. Additional limitations include the different medication regimens and screening protocols used across sites, as well as the range of gestational ages. These limitations, however, are balanced by several key strengths, including the study design which allows prospective assessment of abortion experiences with a high degree of detail, as well as the range of settings and contexts covered by participants from the three countries. The generalizability of study results to other self-managed medication abortion settings may depend on the quality of information and counseling provided, and the medication protocols recommended. Conclusions Findings from this prospective, observational, multi-country pilot study are consistent with the hypothesis that self-managed medication abortion with accompaniment group support is safe and effective. These data will inform a larger, prospective, non-inferiority study to strengthen the findings presented here. These results offer a contribution to policy makers and professional bodies as they imminently consider revisions to task-shifting and other medication abortion provision guidelines, as well as if and how to support the de-medicalization of medication abortion services as healthcare infrastructures around the globe are challenged in unprecedented ways in the wake of a global pandemic. List Of Abbreviations DMOC—Data monitoring and oversight committee WHO—World Health Organization Declarations Ethical approval and consent to participate This study was approved by the Allendale Institutional Review Board (IRB), protocol number SAFE032019, in March 2019. Survey participants gave verbal consent to participate. Consent for publication Not applicable. Availability of data and materials. The datasets generated during the current study are not publicly available due to concerns regarding confidentiality but are available from the corresponding author on reasonable request. Funding This project was supported by a grant from the David and Lucile Packard Foundation. Authorship contributions BG, BKO, CG, HM, IK, RJ, RM, RZ, SF and SN contributed to the quantitative study conceptualization and design, and HM, SR, and RJ conducted the quantitative analyses. HM led the writing of the manuscript, with contributions, review, and approval from all authors. Acknowledgements We wish to thank Azul Alarcon, Amarachi Amaghiro, Ilana Dzuba, Inna Hudaya, Onikepe Owolabi, Tatyana Roberts, Mariana Romero, and Guillermina Peralta who contributed to this work, in various forms. We also wish to thank the study participants, who generously shared their time and personal experiences with data collectors. Competing interests We have no competing interests to declare. References Chemlal S, Russo G. Why do they take the risk? A systematic review of the qualitative literature on informal sector abortions in settings where abortion is legal. BMC Womens Health. 2019;19(1):55. Moseson H, Herold S, Filippa S, Barr-Walker J, Baum SE, Gerdts C. Self-managed abortion: A systematic scoping review. Best Practice & Research Clinical Obstetrics & Gynaecology. 2019. Ganatra B, Gerdts C, Rossier C, Johnson BR, Tunçalp Ö, Assifi A, et al. Global, regional, and subregional classification of abortions by safety, 2010–14: estimates from a Bayesian hierarchical model. The Lancet. 2017;390(10110):2372-81. Singh S, Shekhar C, Acharya R, Moore AM, Stillman M, Pradhan MR, et al. The incidence of abortion and unintended pregnancy in India, 2015. The Lancet Global Health. 2018;6(1):e111-e20. WHO. Medical Management of Abortion. Geneva, Switzerland: World Health Organization; 2018. Report No.: ISBN 978-92-4-155040-6 Dzuba IG, Winikoff B, Pena M. Medical abortion: a path to safe, high-quality abortion care in Latin America and the Caribbean. Eur J Contracept Reprod Health Care. 2013;18(6):441-50. Footman K, Keenan K, Reiss K, Reichwein B, Biswas P, Church K. Medical Abortion Provision by Pharmacies and Drug Sellers in Low- and Middle-Income Countries: A Systematic Review. Stud Fam Plann. 2018;49(1):57-70. Gomperts R, Jelinska K, Davies S, Gemzell-Danielsson K, Kleiverda G. Using telemedicine for termination of pregnancy with mifepristone and misoprostol in settings where there is no access to safe services - Reply. Bjog-an International Journal of Obstetrics and Gynaecology. 2008;115(12):1588-. Gomperts R, van der Vleuten K, Jelinska K, da Costa CV, Gemzell-Danielsson K, Kleiverda G. Provision of medical abortion using telemedicine in Brazil. Contraception. 2014;89(2):129-33. Wilson K, Garcia S, Lara D. Misoprostol Use and Its Impact on Measuring Abortion Incidence and Morbidity. Methodologies for Estimating Abortion Incidence and Abortion-Related Morbidity: a Review. New York, NY: Guttmacher Institute; 2010. p. 191-201. Aiken ARA, Digol I, Trussell J, Gomperts R. Self reported outcomes and adverse events after medical abortion through online telemedicine: population based study in the Republic of Ireland and Northern Ireland. BMJ. 2017;357:j2011. Foster A. Exploring Polish women's experiences using a medication abortion telemedicine service: A qualitative study. Eur J Contracept Reprod Health Care. 2018;23:59-60. Aiken A, Gomperts R, Trussell J. Experiences and characteristics of women seeking and completing at-home medical termination of pregnancy through online telemedicine in Ireland and Northern Ireland: a population-based analysis. BJOG. 2017;124(8):1208-15. Foster AM, Arnott G, Hobstetter M. Community-based distribution of misoprostol for early abortion: evaluation of a program along the Thailand Burma border. Contraception. 2017;96(4):242-7. Gerdts C, Jayaweera RT, Baum SE, Hudaya I. Second-trimester medication abortion outside the clinic setting: an analysis of electronic client records from a safe abortion hotline in Indonesia. BMJ Sex Reprod Health. 2018. Endler M, Lavelanet A, Cleeve A, Ganatra B, Gomperts R, Gemzell-Danielsson K. Telemedicine for medical abortion: a systematic review. BJOG. 2019. Foster A. Providing telemedicine abortion care in Poland: An analysis of 18 months of service delivery through Women Help Women. Eur J Contracept Reprod Health Care. 2018;23:52. Gomperts R, Petow SAM, Jelinska K, Steen L, Gemzell-Danielsson K, Kleiverda G. Regional differences in surgical intervention following medical termination of pregnancy provided by telemedicine. Acta Obstet Gynecol Scand. 2012;91(2):226-31. Gerdts C, Hudaya I. Quality of Care in a Safe-Abortion Hotline in Indonesia: Beyond Harm Reduction. Am J Public Health. 2016;106(11):2071-5. Elizalde S, Mateo N. Las jóvenes: entre la “marea verde” y la decisión de abortar. Salud colectiva. 2018;14(3):433-46. Zurbriggen R, Keefe-Oates B, Gerdts C. Accompaniment of second-trimester abortions: the model of the feminist Socorrista network of Argentina. Contraception. 2018;97(2):108-15. Bullard K, Moseson H, Altamirano S, Bravo M, Cisternas C, Diaz V, et al. Effectiveness of accompaniment of self-managed medication abortion in the second trimester: a retrospective review of case records from Argentina, Chile, and Ecuador Society for Family Planning Annual Meeting 2019; Los Angeles, CA2019. Gerdts C, Jayaweera RT, Kristianingrum IA, Khan Z, Hudaya I. Effect of a smartphone intervention on self-managed medication abortion experiences among safe-abortion hotline clients in Indonesia: A randomized controlled trial. Int J Gynaecol Obstet. 2020;149(1):48-55. Mohdin A. Relaxation of UK abortion rules welcomed by experts. The Guardian. 2020 March 30, 2020. Kapp N, Blanchard K, Coast E, Ganatra B, Harries J, Footman K, et al. Developing a forward-looking agenda and methodologies for research of self-use of medical abortion. Contraception. 2018;97(2):184-8. Cavallo J, Donoho D, Forman H. Hospital Capacity and Operations in the Coronavirus Disease 2019 (COVID-19) Pandemic—Planning for the Nth Patient. JAMA Network. 2020. Topol E. Telemedicine is essential amid the COVID-19 crisis and after it. The Economist. 2020 31 March 2020. Briozzo L, Vidiella G, Rodriguez F, Gorgoroso M, Faundes A, Pons JE. A risk reduction strategy to prevent maternal deaths associated with unsafe abortion. Int J Gynaecol Obstet. 2006;95(2):221-6. Grossman D, Baum SE, Andjelic D, Tatum C, Torres G, Fuentes L, et al. A harm-reduction model of abortion counseling about misoprostol use in Peru with telephone and in-person follow-up: A cohort study. PLoS One. 2018;13(1):e0189195. Endler M, Beets L, Gemzell Danielsson K, Gomperts R. Safety and acceptability of medical abortion through telemedicine after 9 weeks of gestation: a population-based cohort study. BJOG. 2019;126(5):609-18. Stillman M, Owolabi O, Akinyemi A, Moore A, Bankole A, Fatusi A, et al. Women’s self-reported experiences using misoprostol obtained from drug sellers: a prospective cohort study in Lagos State, Nigeria. BMJ Open. 2020(IN PRESS). Bracken H, Clark W, Lichtenberg ES, Schweikert SM, Tanenhaus J, Barajas A, et al. Alternatives to routine ultrasound for eligibility assessment prior to early termination of pregnancy with mifepristone-misoprostol. BJOG. 2011;118(1):17-23. Clark WH, Gold M, Grossman D, Winikoff B. Can mifepristone medical abortion be simplified? A review of the evidence and questions for future research. Contraception. 2007;75(4):245-50. Raymond EG, Harrison MS, Weaver MA. Efficacy of Misoprostol Alone for First-Trimester Medical Abortion: A Systematic Review. Obstet Gynecol. 2019;133(1):137-47. Raymond EG, Tan YL, Comendant R, Sagaidac I, Hodorogea S, Grant M, et al. Simplified medical abortion screening: a demonstration project. Contraception. 2018;97(4):292-6. Schonberg D, Wang LF, Bennett AH, Gold M, Jackson E. The accuracy of using last menstrual period to determine gestational age for first trimester medication abortion: a systematic review. Contraception. 2014;90(5):480-7. Averbach S, Puri M, Blum M, Rocca C. Gestational dating using last menstrual period and bimanual exam for medication abortion in pharmacies and health centers in Nepal. Contraception. 2018;98(4):296-300. Andersen K, Fjerstad M, Basnett I, Neupane S, Acre V, Sharma SK, et al. Determination of medical abortion eligibility by women and community health volunteers in Nepal: A toolkit evaluation. PLoS One. 2017;12(9):e0178248. Schmidt-Hansen M, Cameron S, Lohr PA, Hasler E. Follow-up strategies to confirm the success of medical abortion of pregnancies up to 10 weeks' gestation: A systematic review with meta-analyses. Am J Obstet Gynecol. 2019. Perriera LK, Reeves MF, Chen BA, Hohmann HL, Hayes J, Creinin MD. Feasibility of telephone follow-up after medical abortion. Contraception. 2010;81(2):143-9. von Hertzen H, Piaggio G, Huong NTM, Arustamyan K, Cabezas E, Gomez M, et al. Efficacy of two intervals and two routes of administration of misoprostol for termination of early pregnancy: a randomised controlled equivalence trial. The Lancet. 2007;369(9577):1938-46. Fjerstad M, Sivin I, Lichtenberg ES, Trussell J, Cleland K, Cullins V. Effectiveness of medical abortion with mifepristone and buccal misoprostol through 59 gestational days. Contraception. 2009;80(3):282-6. Appendix Appendix I: Medication Abortion Protocols as of March 2019 & Contraindications South America Mifepristone + Misoprostol for pregnancies up to 84 days: Oral/Sublingual Swallow 1 tablet of mifepristone (200mg) with a glass of water After 36-48 hours, put 4 pills of misoprostol (800mcg) under the tongue (sublingual) and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve. Mifepristone + Misoprostol for pregnancies up to 84 days: Oral/Vaginal Swallow 1 tablet of mifepristone (200mg) with a glass of water After 36-48 hours, put 4 pills of misoprostol (800mcg) inside the vagina, fairly deep into the vagina. Rest for one hour with your legs up. (Before placing the pills, you can splash them with water.) Contraindications If a caller reports any of an: c-section within the past six months, ectopic pregnancy, chronic adrenal failure, long term corticosteroid therapy, intolerable known allergy to mifepristone or misoprostol, current use of IUD, or hemorrhagic disorders, or has not chosen to terminate the pregnancy of their own free will, the caller is deemed ineligible for medication abortion. South East Asia Mifepristone + Misoprostol for pregnancies up to 84 days Swallow 1 tablet of mifepristone (200mg) with a glass of water After 24 hours, put 4 pills of misoprostol (800mcg) under the tongue (sublingual) and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve. If no signs of reaction, side effects and expulsion has not occurred after 3 hours, put 2 pills of misoprostol (400mcg) under the tongue (sublingual) and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve . Take 2 pills misoprostol the same way every 3 hours until the products of conception expel. Misoprostol alone for pregnancies up to 84 days Put 4 pills of misoprostol (800mcg) under the tongue (sublingual) and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve. Wait for 3 hours. If no signs of reaction, side effects and expulsion has not occurred, after 3 hours, put add another 2 pills (400 mcg) the same way. Repeat 2 pills the same way every 3 hours until when the product of conception expel. Mifepristone + Misoprostol for pregnancies beyond 84 days Swallow 1 tablet of mifepristone (200mg) with a glass of water After 24 hours, Put 2 pills of misoprostol (400mcg) under the tongue (sublingual) and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve. Wait for 3 hours. Repeat 2 pills the same way every 3 hours and stop when the product of conception expelled. Misoprostol only for pregnancies beyond 84 days Swallow 1 tablet of mifepristone (200mg) with a glass of water After 24 hours, Put 2 pills of misoprostol (400mcg) under the tongue (sublingual) and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve. Wait for 3 hours. Repeat 2 pills the same way every 3 hours and stop when the product of conception expelled. Contraindications If a caller reports any of the following: c-section within the past six months, ectopic pregnancy, chronic adrenal failure, long term corticosteroid therapy, intolerable known allergy to mifepristone or misoprostol, current use of IUD, or hemorrhagic disorders, the caller is deemed ineligible for medication abortion, but may still proceed with counselor and referral for surgical abortion services. Anyone who is not interested in terminating of their own free will is ineligible. West Africa The hotline in West Africa provides information to callers based on the WHO protocol for medication abortion: Misoprostol only for pregnancies up to 84 days 12 misoprostol pills of 200 mcg each (2400 mcg of misoprostol total) Put 4 pills (800mcg) under the tongue (sublingual) and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve. Wait for 3 hours. After 3 hours, put the second dose of 4 pills (800 mcg) under the tongue and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve. Wait for 3 hours. After 3 hours, put a third dose of 4 pills (800 mcg) under the tongue and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve. Mifepristone + Misoprostol for pregnancies up to 84 days 1 mifepristone tablet of 200 mg and 4 misoprostol tablets of 200 mcg each (800 mcg of misoprostol total) Swallow 1 tablet of mifepristone (200mg) with a glass of water After 24 hours, put 4 pills (800 mcg) of misoprostol between the gum and the cheek (buccal), two on the left side and two on the right side. All four pills should be left in the mouth for approximately 30 minutes to dissolve. Contraindications If a caller reports any of: a current IUD, allergy to misoprostol, current sexually transmitted infection, an ectopic pregnancy, or has not chosen to terminate the pregnancy of their own free will, the caller is deemed ineligible for medication abortion. Appendix 2. Self-managed medication abortion outcomes by gestational age <8 weeks n=141 8-9 weeks n=40 10-12 weeks n=16 13-17 weeks n=3 GA missing n=2 n % n % n % n % n % Abortion outcome Felt abortion was complete 134 95.0 37 92.5 16 100.0 3 100.0 2 100.0 Felt abortion was complete & no surgical intervention 133 94.3 36 90.0 15 93.8 3 100.0 2 100.0 Felt unsure if abortion was complete 5 3.5 2 5.0 0 0.0 0 0.0 0 0.0 Felt abortion was NOT complete 2 1.4 1 2.5 0 0.0 0 0.0 0 0.0 Reported a miscarriage prior to taking pills 2 0 0 0 0 Lost to follow-up prior to taking pills 11 7 4 1 0 Cite Share Download PDF Status: Published Journal Publication published 27 Oct, 2020 Read the published version in Reproductive Health → Version 2 posted Editorial decision: Accept 29 Sep, 2020 Review # 2 received at journal 22 Sep, 2020 Reviewer # 2 agreed at journal 18 Sep, 2020 Review # 1 received at journal 03 Sep, 2020 Reviewer # 1 agreed at journal 02 Sep, 2020 Reviewers invited by journal 01 Sep, 2020 Editor assigned by journal 30 Aug, 2020 Submission checks completed at journal 29 Aug, 2020 Editor invited by journal 29 Aug, 2020 You are reading this latest preprint version Show more versions Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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1","display":"","copyAsset":false,"role":"figure","size":21253,"visible":true,"origin":"","legend":"Screening and recruitment of callers to safe abortion accompaniment groups in South America, Southeast Asia, and West Africa over a one-month period","description":"","filename":"Figure1Flowchart.jpg","url":"https://assets-eu.researchsquare.com/files/rs-31998/v2/Figure1Flowchart.jpg"},{"id":13587558,"identity":"1a6129f0-da65-4aaf-b6cd-ae66611c3ec1","added_by":"auto","created_at":"2021-09-17 04:51:32","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":694905,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-31998/v2/490df1c3-99d7-4f3c-9fbd-d4b6c67943f6.pdf"}],"financialInterests":"","formattedTitle":"Self-managed medication abortion outcomes: results from a prospective study","fulltext":[{"header":"Plain English Summary","content":"\u003cp\u003eSelf-managed abortion describes anything someone does to end a pregnancy without help or supervision from a doctor, nurse, or other clinicians. People self-manage abortions for many reasons—sometimes because they cannot access abortion in a clinic or hospital because abortion is illegal in their area, or the nearest clinic is too far away, or they do not have the money to pay for one; other times, people choose to self-manage their abortions because it is more private, and can be done from their own home. To determine whether it was possible to recruit people into a research study about experiences with a stigmatized and legally restricted experience (self-managed abortion), and also to evaluate hypotheses about the effectiveness of self-managed medication abortion, we conducted a pilot study. In this pilot study, we recruited people who contacted a safe abortion hotline (accompaniment group) looking for information about self-managed abortion, and we followed them forward in time to measure what happened. In one month, we recruited 227 people across three countries, and followed them for up to six weeks to measure whether they obtained medication abortion pills, if they took them, and if their abortion was successful. We found that people were willing to participate in a study about this topic, and that almost everyone obtained medication (89%). Among those that took medication, almost everyone (95%) had a complete abortion. These results are encouraging for future research on this topic, and suggest that self-managed abortion with pills is effective and safe.\u003c/p\u003e "},{"header":"Background","content":"\u003cp\u003eAround the world, people face structural barriers and legal restrictions that prevent access to high-quality abortion services. Even when abortion services are available in facility settings, some people prefer out-of-clinic abortion care for reasons related to privacy, autonomy, and concerns such as stigma, mistreatment, and high cost.(1, 2) The reasons that people attempt to self-manage abortion—defined here as ending one’s own pregnancy outside of a formal health-care setting—and the means by which they do so, vary widely by setting.(1, 2) The incidence of self-managed abortion is not well studied; estimates suggest that approximately 45 percent of abortions worldwide in 2010–2014 took place outside of a health facility(3) - and in some settings, the proportion may be closer to 70 or 80 percent.(3, 4)\u003c/p\u003e\n\u003cp\u003eGiven the barriers to abortion access in clinical settings, those in need of abortion care are increasingly obtaining mifepristone and misoprostol, World Health Organization (WHO) recommended medications for abortion,(5) through informal sector routes including online services, pharmacies, hotlines, and drug sellers.(6–10) There is a growing body of literature from around the world indicating that when individuals have access to information about how to obtain the pills, how to take the pills, how to assess for completion, and warning signs that may indicate potential complications, the practice of self-managed medication abortion is safe and the experience satisfactory.(8, 9, 11–15) Much of the published literature has focused specifically on the experiences of self-managed medication abortion with telemedicine support from online websites that provide access to pills as well as information on how to use them via email communication; these studies report safe and effective abortion experiences.(2, 8, 12, 13, 16–18)\u003c/p\u003e\n\u003cp\u003eBeyond online websites, people obtain information, medications, and support to self-manage their abortions in a variety of other ways as well. One emerging model is abortion accompaniment, where trained volunteers provide WHO-recommended evidence-based information about medication abortion, as well as physical and emotional support and person-centered care throughout the medication abortion process, over the phone or in person, outside of the formal health care system.(15, 19–22) This non-clinic based model of counselor-supported self-managed medication abortion care has come to be known as the “accompaniment model,” as people are virtually “accompanied” through the medication abortion process. Approximately fifty accompaniment groups are in operation around the world, providing support and information about self-managed medication abortion. However, despite the increasing number of abortion accompaniment groups worldwide, little research has documented the safety and effectiveness of the abortion accompaniment model. Among accompaniment clients, we are aware of only three studies that have reported on outcomes of self-managed medication abortion; all found high levels of abortion completion, and few complications.(15, 22, 23)\u003c/p\u003e\n\u003cp\u003eOf the data that do exist, however, there are important limitations– including a heavy reliance on retrospective records that were not collected for the purposes of research. Evidence suggests that a high proportion of abortions occur outside of the health care system and changing global dynamics may continue to shift more abortions outside of the healthcare system.(24) Well-designed, rigorously-collected data are needed to assess the safety and effectiveness of medication abortion administered completely outside of the formal healthcare system—such as the accompaniment model—to contribute to our understanding of de-medicalized models of abortion care.(25)\u003c/p\u003e\n\u003cp\u003eTo address this gap, we designed a pilot prospective observationalstudy of the effectiveness and safety of self-managed medication abortion with accompaniment group support in three countries. We conducted the pilot study to inform the design and implementation of a larger, non-inferiority trial to prospectively evaluate the effectiveness of self-managed medication abortion with accompaniment group support as compared to the effectiveness of medication abortion in a clinical setting. The primary aims of the pilot study were to (1) assess the feasibility of implementing a prospective study to recruit and follow callers to abortion accompaniment groups; and (2) evaluate hypotheses about the effectiveness and experiences of self-managed abortion under this model of care. While these data come from a pilot study, so do not represent results that are powered to make definitive statements about safety, these data provide foundational evidence for other studies in development on self-managed abortion, particularly as we find ourselves in a moment of history where delivery of healthcare services by the formal sector will require innovation, and where healthcare infrastructures around the globe will be challenged in unknowable ways.(26, 27) All of these factors could lead to an increase in incidence of and demand for self-managed abortion. These pilot study data represent some of the first ever prospective data on the effectiveness of self-managed abortion,(2, 15, 22, 23) and provide insight into ways that healthcare systems could adapt to support those who choose to or need to self-manage abortions.\u003c/p\u003e "},{"header":"Methods","content":"\u003ch2\u003eStudy setting\u003c/h2\u003e\n\u003cp\u003eA research consortium that includes researchers, advocates, and accompaniment providers collaboratively designed this study to ensure that it reflected the priorities, experiences, and preferences of people who self-manage abortions with medication. Study investigators invited individual consortium members (included as co-authors) to participate based on their expertise in self-managed medication abortion and accompaniment models in a range of legal and cultural settings, to ensure the design of a study that reflected the lived experiences of people who self-manage, the accompaniers who support them, and contexts similar to those in which the study will take place. The overall study protocol was reviewed and approved by the Allendale Investigational Review Board, by a local IRB as appropriate, and by a study-specific Data Monitoring and Oversight Committee (DMOC) with medication abortion experts from each study country, and a chair with research expertise in clinical medication abortion effectiveness studies.\u003c/p\u003e\n\u003cp\u003eData for this study were collected in three countries located in South America, Southeast Asia, and West Africa. The names of the abortion accompaniment groups and their home countries are blinded due to safety and legal concerns for those managing the hotlines, and the hotline callers. The three included accompaniment groups were selected to represent variation in legal and sociocultural contexts with respect to abortion, and because they each had identified research as an important mechanism for informing policy and practice. The three accompaniment groups vary somewhat in their approach, but each involves an initial screening conversation with the pregnant person that takes place via secure messaging or a telephone call. During this screening conversation, the accompaniment counselor confirms that the person is seeking abortion for themselves, that the person is not being coerced, and that they have no known contraindications to medication abortion. Further, the counselor assesses the gestational age of the pregnancy based on either the date of last menstrual period as reported by the caller, or an independently acquired ultrasound. For callers who obtained an ultrasound, gestational age is based on the ultrasound dating. After confirming eligibility for medication abortion, the counselors then provide step-by-step instructions for how to use medication to induce abortion based on current WHO protocols (Appendix 1; of note, some of these regimens include off-label use of mifepristone and misoprostol), information on obtaining the medications, and highly detailed guidance on assessing abortion completion and potential warning signs of complications, as well as when formal healthcare may be needed. Accompaniment group staff are in frequent contact with callers during the medication abortion process to answer questions and provide support to the person self-managing an abortion. The accompaniment group in South America provides information primarily on a combined mifepristone and misoprostol regimen, while the groups in Southeast Asia and West Africa counsel on both a combined and misoprostol alone regimen, depending on which pills the caller is able to obtain.\u003c/p\u003e\n\u003ch2\u003eStudy design and data collection\u003c/h2\u003e\n\u003cp\u003eThis pilot study was a prospective, observational study in which people who contacted an accompaniment group for information and support with self-managing a medication abortion were enrolled and followed for up to six weeks to assess their abortion outcome and experiences. As one of the primary aims of the pilot study was to assess feasibility, sample size was flexibly set to the number of people counselors could successfully recruit in 30 days. Pilot study enrollment at each site was open for approximately 30 days in April and May of 2019. Participants were followed up to six weeks, with most followed for three-weeks. We conducted the last follow-up interview in June 2019. Survey instruments were professionally translated into local languages as needed for each site, and were then pre-tested with four to five cognitive interviews in each country (13 total), and then updated accordingly.\u003c/p\u003e\n\u003cp\u003eDuring the initial counseling conversation, accompaniment counselors assessed all callers to the accompaniment group for eligibility for study participation during the 30 days. Eligibility criteria included: (1) having contacted the accompaniment group seeking information about induced abortion for their own pregnancy; (2) being at least 13 years of age; (3) being able to give informed consent; (4) being able to speak a local language; (5) meeting hotline eligibility criteria for starting the medication abortion process (i.e. no contraindications to medication abortion; Appendix 1); and (6) starting a new medication abortion process. Callers were excluded from the study if they (1) had taken medications in an attempt to end the current pregnancy within the 30 days prior to contacting the hotline; (2) were experiencing ongoing symptoms of spontaneous or induced abortion (bleeding, cramping) at the time of contacting the hotline; (3) had a known ectopic pregnancy; (4) did not want to share their contact information with study staff; (5) did not want to be contacted again by the hotline or by study staff; or (6) were not willing to comply with study procedures. Callers of any gestational age were eligible to participate in the study. Eligible participants were invited to participate by the accompaniment counselor at the end of the first counseling conversation. Participants who expressed interest proceeded through an informed consent conversation with detailed information about study participation, risks and benefits. All participants who gave their informed consent to participate were enrolled into the pilot study.\u003c/p\u003e\n\u003cp\u003eImmediately after enrollment, each participant answered baseline questions about their current pregnancy, reproductive history, contact information, and select sociodemographic characteristics. Follow-up surveys were completed by trained study coordinators at each site, recruited from trusted partner organizations, and employed full time on the research study for the duration of recruitment and data collection at each site. The first follow-up survey was conducted over the phone (voice-call or secure messaging) one-week after the pills were scheduled to be taken. This one-week follow-up inquired about obtaining the medications, medication type, detailed information on timing and route of administration, pain, bleeding and cramping during the abortion, and self-reported assessment of abortion completion. Two weeks after the first follow-up, approximately three-weeks after the medication was taken, study coordinators contacted participants for a second-follow-up that included questions about any additional doses taken, warning signs of complications, completion of abortion, healthcare seeking, disclosure of the abortion, satisfaction with the accompaniment group, and emotions about the experience. Participants who reported they were no longer planning to take the pills, were asked why, and no further follow-up was conducted. Participants received an incentive in the form of phone credit for each survey completed. Study coordinators entered all survey data into a secure, online platform.\u003c/p\u003e\n\u003ch2\u003eStudy measures\u003c/h2\u003e\n\u003cp\u003eEffectiveness of self-managed medication abortion. The primary outcome of interest was effectiveness of self-managed medication abortion with accompaniment group support, defined as complete abortion at last study contact, without surgical intervention at any point. We classified an abortion process as “effective” if the participant responded “yes” to the question, “Do you feel that your abortion process is complete?” and did not report a surgical intervention when asked “At the health facility, what treatment did you receive?” (among participants who reported seeking medical care at a health facility during or after their abortion process). Participants also reported why they felt their abortion was complete, and if they had an ultrasound, or had taken a pregnancy test to confirm completion. We also calculated a secondary, more inclusive definition of “effective”– defined as a participant who was no longer pregnant at the end of follow-up, regardless of whether surgical intervention took place or not.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eComplications. \u003c/em\u003eWarning signs of potential complications of self-managed medication abortion were assessed by asking participants to self-report any occurrence of (1) heavy bleeding that soaked more than two pads per hour for more than two hours, (2) pain that did not go away with the use of painkillers, (3) fever that lasted for over 24 hours, and (4) foul smelling vaginal discharge. Participants were also asked about whether they experienced side effects at any point in the abortion process, including fever, diarrhea, nausea, vomiting, or dizziness, as well as signs of potential allergic reaction, including itchiness, difficulty breathing, sweaty hands, or face numbness.\u003c/p\u003e\n\u003cp\u003eComplications were identified based on participant self-report and receipt of treatment. Those who sought care at a facility at any point in the process were asked why they sought care and what treatment they received (surgical intervention, antibiotics, other medications, or observation).\u003c/p\u003e\n\u003ch2\u003eAnalysis\u003c/h2\u003e\n\u003cp\u003eWe summarized baseline sociodemographic characteristics and data on reproductive history for the study population through measures of frequency and central tendency. We then calculated the proportion of participants who successfully obtained medications for abortion and used the medications to self-manage abortion at the one-week follow-up, and described the medication abortion experience stratified by type of medication regimen. Finally, we calculated the proportion of participants who completed the abortion, the proportion who sought care, and the proportion that reported warning signs of complications by the three-week follow-up. We conducted all analyses in Stata version 15.0. We double-entered study data for 46 participants (20%) to check for any systematic errors in data entry. We then conducted a sensitivity analysis to re-estimate the primary outcome under the conservative assumption that all those lost to follow-up had incomplete abortions.\u003c/p\u003e "},{"header":"Results","content":"\u003ch2\u003eSample characteristics\u003c/h2\u003e\n\u003cp\u003eStudy recruiters screened 346 callers for eligibility during the 30-day recruitment period (Figure 1). Seventy-four callers (21%) were ineligible due to calling about something other than medication abortion, having already begun a medication abortion process, being outside of the hotline gestational age range, being undecided about abortion, or unwilling to receive follow-up. During the initial counseling conversation prior to starting a medication abortion process, one participant described symptoms of a possible ectopic pregnancy. Upon hearing these symptoms, the counselor immediately referred the participant to a health facility for an ultrasound, where an ectopic pregnancy was confirmed, and the participant received appropriate and effective medical care. The study coordinator consequently classified this person as ineligible for study follow-up. Aside from this person, the study team enrolled 227 participants across the three sites. Two-hundred and four participants (90%) completed the one-week survey, and 175 (77%) completed the three-week survey.\u003c/p\u003e\n\u003cp\u003eAt baseline, the majority of participants (75%) were less than 30 years of age, and 84% had at least some secondary education (Table 1). The majority of participants identified the pregnancy with a pregnancy test (89%), followed most closely by ultrasound (19%), and/or a late or missed menstrual period (15%). Only one participant (0.4%) reported a pregnancy that was not confirmed by a pregnancy test or ultrasound. At the time of enrollment, 68% of participants had a pregnancy of less than eight weeks gestation, 21% between 8–9 weeks, 9% between 10–12 weeks, and 2% between 13 and 17 weeks. Only one study site measured method of gestational age ascertainment; most participants at this site assessed their gestational age based on date of the last menstrual period (79%). Ten percent of participants reported a prior attempt to end the current pregnancy, before contacting the accompaniment group. Prior attempts to end the pregnancy included ingesting herbs or using emergency contraception pills with intent to terminate.\u003c/p\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cdiv class=\"SimplePara\"\u003eSociodemographic characteristics of 227 callers to accompaniment groups pursuing self-managed medication abortion in three countries in South America, Southeast Asia, and West Africa.\u003c/div\u003e \u003c/div\u003e \u003c/caption\u003e\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"159\"\u003e\n\u003cp\u003e\u003cstrong\u003eTotal \u003cbr /\u003e (n=227)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e\u003cstrong\u003eParticipant age (years)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e\u0026lt;18\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e1.8\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e18-19\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e4.8\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e20-24\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e80\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e35.2\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e25-29\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e74\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e32.6\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e30-34\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e31\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e13.7\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e35-39\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e23\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e10.1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e40-45\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e2.2\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e\u003cstrong\u003eLevel of Education\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003eNone\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e0.4\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003ePrimary\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e33\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e14.5\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003eSecondary\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e70\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e30.8\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e\u0026gt;Secondary\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e120\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e52.9\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003eMissing\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e1.3\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e\u003cstrong\u003ePregnancy Characteristics\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e\u003cstrong\u003eAscertainment of Pregnancy (select all)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003ePregnancy Test\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e202\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e89.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003eUltrasound\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e44\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e19.4\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003eLate/Missed Period\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e34\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e15.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003ePregnancy Symptoms\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e28\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e12.3\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003eOther\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e3.1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e\u003cstrong\u003eGestational Age\u0026nbsp; \u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e\u0026lt;8 weeks\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e154\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e67.8\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e8 or 9 weeks\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e47\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e20.7\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e10-12 weeks\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e20\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e8.8\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003e13-17 weeks\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e1.8\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"282\"\u003e\n\u003cp\u003eMissing\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e0.9\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003ch2\u003eUse of medication abortion pills\u003c/h2\u003e\n\u003cp\u003eAt the one-week follow-up, 202 participants (90% of those enrolled and 99% of those who participated in the one-week survey) had obtained the medication - just under half of these 202 participants reported obtaining the medication from a pharmacy (n = 97, 49%). Two participants (1%) reported having had a miscarriage prior to taking the medications, and did not complete subsequent follow-ups; and 23 participants (10%) were lost to follow-up at one week. All participants who obtained the medications and completed the one-week survey (n = 202) reported taking them by the one-week follow-up (Table 2). Slightly over half of participants at the one-week follow-up (n = 107, 53%) reported taking mifepristone and misoprostol in combination, 47% (n = 94) reported taking misoprostol alone, and one participant did not report medication used. Participants most commonly utilized sublingual administration for misoprostol (n = 339 of 370 doses, 92%).\u003c/p\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cdiv class=\"SimplePara\"\u003eMedication abortion pills sourcing and utilization at one-week follow-up among 204 callers to accompaniment groups pursuing self-managed medication abortion in three countries in South America, Southeast Asia, and West Africa.\u003c/div\u003e \u003c/div\u003e \u003c/caption\u003e\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003e\u003cstrong\u003eMedication characteristics\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" rowspan=\"2\" width=\"158\"\u003e\n\u003cp\u003e\u003cstrong\u003eOne-week follow-up \u003cbr /\u003e (n=204)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003e\u003cstrong\u003eHave you gotten the pills yet?\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003en=204\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003eYes\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003e202\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e99.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003eYes, but did not take b/c had a miscarriage\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e0.5\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003eNo, had a miscarriage prior to obtaining\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e0.5\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003e\u003cstrong\u003eHow were the pills packaged?\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003en=202\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003eBlister pack\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003e90\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e44.6\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003eLoose pills\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003e90\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e44.6\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003eMissing\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003e22\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e10.9\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003e\u003cstrong\u003eHave you taken the pills yet?\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003en=202\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003eYes\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003e202\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e100.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003e\u003cstrong\u003eMedication regimen\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003en=202\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003eMifepristone and misoprostol\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003e107\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e53.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003eMisoprostol alone\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003e94\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e46.5\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003eMissing\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e0.5\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003e\u003cstrong\u003eMisoprostol route of administration \u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003en=370\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003eSublingual\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003e339\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e91.6\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003eBuccal\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003e15\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e4.1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003eVaginal\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003e12\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e3.2\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003eOral\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e0.5\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"300\"\u003e\n\u003cp\u003eMissing\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"78\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"80\"\u003e\n\u003cp\u003e0.5\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003ch2\u003eCompletion of self-managed medication abortion\u003c/h2\u003e\u003cp\u003eThree weeks after taking the medications, 95% of participants (n = 192) who took medications reported feeling that their abortion was complete at their last follow-up, and 94% (n = 189) felt their abortion was complete \u003cem\u003eand \u003c/em\u003ehad not reported surgical intervention (Table 3). Among the participants who had a complete abortion, three (1.5%) reported a surgical intervention to evacuate the uterus. Seven participants (3.5%) reported being “not sure” that their abortion was complete; four of these participants reported having felt the products of conception expel, but reported being unsure about the abortion completion because they had not yet taken a pregnancy test or had an ultrasound to confirm they were no longer pregnant. Another participant was unsure because she reported still feeling some “pregnancy symptoms,” and another was unsure because of a lack of confidence in medication abortion versus the certainty of surgical abortion. Three participants (1.5%) reported that they did not feel that their abortion was complete. One was still bleeding, and thus felt the process was not complete. The other two sought care in the formal healthcare system and were told by healthcare providers that their abortions were incomplete; however, healthcare providers did not intervene surgically or medically. Completion by gestational age is included in Appendix 2. We have no data on whether medications were taken or any subsequent outcomes for 23 participants (10%) who did not complete \u003cem\u003eany\u003c/em\u003e post-enrollment follow-up. In a sensitivity analysis, we assumed that all of these lost participants (n = 23) obtained the medications and took them, but none had a complete abortion; under this assumption, the estimated proportion with a complete abortion at three-weeks post enrollment would then fall to 85%, or 192 out of 225 participants (excluding the two who miscarried prior to taking the pills).\u003c/p\u003e\n\u003ch2\u003ePhysical experience of self-managed medication abortion\u003c/h2\u003e\n\u003cp\u003eAcross both medication regimens, nearly all participants experienced bleeding and cramping during the abortion process (Table 3). The majority of participants reported using at least one technique to manage the pain (asked at one week in Southeast Asia, and at two weeks in South America and West Africa): most commonly pain medications (n = 118 of 181, 65%), followed by methods of distraction, such as listening to music or watching television (n = 18, 10%) (Table 4). Participants also reported several side effects. Participants reported nausea most commonly (n = 111, 61%), followed by fever/chills (n = 110, 60%), diarrhea (n = 90, 50%), vomiting (n = 61, 34%), and dizziness (n = 7, 4%). Few participants reported signs of an allergic reaction to the medications.\u003c/p\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cdiv class=\"SimplePara\"\u003eOutcomes and experiences of self-managed medication abortion with accompaniment support among 202 participants who took the medications. Medication regimen is missing for one participant.\u003c/div\u003e \u003c/div\u003e \u003c/caption\u003e\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" rowspan=\"2\" width=\"78\"\u003e\n\u003cp\u003e\u003cstrong\u003eTotal\u003cbr /\u003e (n=202)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" rowspan=\"2\" width=\"84\"\u003e\n\u003cp\u003e\u003cstrong\u003eMife + Miso regimen\u003cbr /\u003e (n=107)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" rowspan=\"2\" width=\"78\"\u003e\n\u003cp\u003e\u003cstrong\u003eMiso only regimen\u003cbr /\u003e (n=94)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003e\u003cstrong\u003eDid you experience any bleeding?*\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003eYes\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e196\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e97.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e105\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e98.1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e90\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e95.7\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003eNo\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e0.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e0.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e1.1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003eMissing\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e2.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e1.9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e3.2\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003e\u003cstrong\u003eDid you experience any cramping/contractions?*\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003eYes\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e192\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e95.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e99\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e92.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e92\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e97.9\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003eNo\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e3.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e6.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e0.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003eMissing\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e1.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e0.9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e2.1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003e\u003cstrong\u003eAbortion outcome\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003eReported feeling abortion was complete\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e192\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e95.1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e103\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e96.3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e88\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e93.6\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003eReported feeling abortion was complete and no surgical intervention\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e189\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e93.6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e101\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e94.4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e87\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e92.6\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003eReported feeling unsure if abortion was complete**\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e3.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e1.9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e5.3\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003eReported feeling that abortion was NOT complete***\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e1.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e1.9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e1.1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"78\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"84\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"78\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003e\u003cstrong\u003eIf complete, how did you know? (select all)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"78\"\u003e\n\u003cp\u003en=192\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"84\"\u003e\n\u003cp\u003en=103\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"78\"\u003e\n\u003cp\u003en=88\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003eSaw products of conception\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e91\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e47.4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e57\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e55.3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e34\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e38.6\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003eNegative pregnancy test\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e36\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e18.8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e8.7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e27\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e30.7\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003e\u0026nbsp;\u0026nbsp;\u0026nbsp; Pregnancy symptoms ended\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e97\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e50.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e47\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e45.6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e50\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e56.8\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003eUltrasound confirmed completion\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e33\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e17.2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e10\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e9.7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e23\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e26.1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003eClinician told me\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e4.2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e7.8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e0.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"360\"\u003e\n\u003cp\u003eAccompanier/counselor told me\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e30\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e15.6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e30\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"42\"\u003e\n\u003cp\u003e29.1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"30\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e0.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n \u003ctr\u003e\u003ctd colspan=\"16\"\u003e\u003cp\u003e\u003cem\u003e* Reported at one-week follow-up \u003cbr /\u003e ** The most common reason given for being \u0026ldquo;not sure\u0026rdquo; that an abortion was complete was because the participant had not yet taken a pregnancy test to confirm completion, despite having felt the products of conception expel.\u003cbr /\u003e *** One participant who said their abortion was not complete was still bleeding at the last follow-up.\u003cbr /\u003e \u003cbr /\u003e \u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\n\u003ch2\u003eSafety of self-managed medication abortion\u003c/h2\u003e\n\u003cp\u003eIn the three weeks following medication abortion, some participants reported warning signs of potential complications (Table 4), most commonly foul smelling discharge (n = 9, 5%), bleeding that soaked more than two sanitary pads per hour for more than two hours (n = 8, 4%), pain that did not go away (n = 7, 4%), and fever that lasted more than 24 hours (n = 1, 0.6%). Disproportionately more participants, however, reported seeking care during or after the self-managed medication abortion process (n = 60, 33%). Most of the participants that sought formal health care (n = 40 of 60, 67%) did so to confirm completion of the abortion, commonly at diagnostic laboratories rather than at a clinic or hospital. Of the participants who took medications, five (3%) received other medications, three (1.5%) received a surgical intervention (manual vacuum aspiration or dilation and curettage), and two (1%) received antibiotics. No major adverse events were reported, such as hysterectomy or death.\u003c/p\u003e \n\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cdiv class=\"SimplePara\"\u003ePhysical experiences of self-managed medication abortion, as well as health care seeking among callers pursuing self-managed medication abortion with accompaniment support. Data reported at one week and three-week follow-up in Southeast Asia, and at three week follow-up only in South America and West Africa, hence the denominator of 181.\u003c/div\u003e \u003c/div\u003e \u003c/caption\u003e\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"151\"\u003e\n\u003cp\u003e\u003cstrong\u003eTotal \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u0026nbsp;\u0026nbsp; n\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; %\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003e\u003cstrong\u003eSide effects\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003en=181\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eNausea\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e111\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e61.3\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eAny fever, for any duration\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e110\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e60.1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eDiarrhea\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e90\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e49.7\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eVomiting\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e61\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e33.7\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eDizziness\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e3.9\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003e\u003cstrong\u003eSigns of potential allergic reaction\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003en=181\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eItchiness\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e15\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e8.3\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eDifficulty breathing\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e1.1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eSweaty hands\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e0.6\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eFace numbness\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e0.6\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003e\u003cstrong\u003eWarning signs of complications\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003en=181\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eFoul smelling discharge\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e5.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eBleeding 2+ hours\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e4.4\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003ePain that doesn't go away\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e4.1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eFever over 24 hours\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e0.6\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003e\u003cstrong\u003ePain management method\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003en=181\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003ePain medications\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e118\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e65.2\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eDistraction\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e18\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e9.9\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eMassage/hot water\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e10\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e5.5\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003e\u003cstrong\u003eSought health care at a facility for any reason\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003en=181\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eYes\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e60\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e33.1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eNo\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e114\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e63.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eMissing\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e3.9\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003e\u003cstrong\u003eReason for seeking care\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003en=60\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eConfirm abortion\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e40\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e66.7\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eSymptoms/side effects (pain, fainting, bleeding)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e8.3\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eMissing\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e15\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e25.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003e\u003cstrong\u003eTreatment received (select all)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003en=60\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eObservation/confirmation of termination\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e50\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e83.3\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eMedications/tablets\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e8.3\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eSurgical intervention\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e5.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eAntibiotics\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e3.3\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003e\u003cstrong\u003eDisclosed to provider about abortion?\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003en=60\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eYes\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e18\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e30.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eNo\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e39\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e65.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"312\"\u003e\n\u003cp\u003eMissing\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"89\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"62\"\u003e\n\u003cp\u003e5.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Discussion","content":"\u003cp\u003eFindings from this pilot study indicate that recruitment and prospective follow-up of callers to abortion accompaniment groups is feasible, and provide preliminary evidence that self-managed medication abortion with accompaniment group support is an effective model of abortion care. During approximately one month of follow-up, across three diverse settings, the majority of pilot study participants obtained medication abortion pills, took the medication abortion pills following information provided by accompaniment group counselors, and completed their abortion without the need for surgical intervention, and without major complications or other safety events.\u003c/p\u003e\n\u003cp\u003eThe findings presented here build on a robust body of evidence that points to a similar conclusion: self-managed medication abortion with accurate information on how to use the pills can be effective and safe.(2, 7, 8, 11, 14, 15, 22, 28–31) This pilot study has demonstrated that research conducted in close partnership with groups that provide abortion accompaniment is a promising avenue to improve understanding of self-managed abortion. These groups facilitate the efficient identification of people self-managing their abortions (a group that has been historically difficult to identify and recruit for studies(25)) and enables deeper insight into these experiences given the naturally consistent interaction that often occurs between counselors and callers throughout the accompaniment process. However, conducting rigorous evaluations of this de-medicalized model of care has a unique set of challenges, primarily the reliance of self-report for gestational age assessment and measurement of all primary outcomes. This approach reflects a high degree of confidence and trust in participant ability to self-assess study outcomes, as well as limitations imposed by legal restrictions in each country. Additionally, research from clinical settings has demonstrated the accuracy of report of last menstrual period as compared to ultrasound assessment(32–36): the largest study to date found that only 3.3% of 4,257 medication abortion clients from ten clinics across the United States had a gestational age beyond 63 days by ultrasound assessment but a gestational age below 63 days based on last menstrual period.(32) Even for those who may be off in their gestational age assessments, research has demonstrated that early medication abortion remains safe and highly acceptable without screening ultrasound.(35) Indeed, WHO technical guidance does not require ultrasound confirmation of gestational age for early medication abortion,(5) and last menstrual period is the typical assessment for pregnancy dating in many study contexts.(37, 38) Furthermore, studies assessing the effectiveness of telemedicine for abortion, home administration of misoprostol, and telephone follow-up after a clinic-based medication abortion have demonstrated the reliability of self-report of completion based on structured criteria.(39, 40)\u003c/p\u003e\n\u003cp\u003eOur study also suffered from loss-to-follow-up. To understand the extent to which this could have biased results, we conducted a sensitivity analysis in which we made the most conservative assumption that all participants who were lost-to-follow-up had a failed abortion. Under this conservative assumption, the overall effectiveness of self-managed abortion with accompaniment support is 85% - which is similar to the efficacy of misoprostol alone demonstrated in clinical trials.(41) Additionally, the proportion lost to follow-up is comparable to typical loss to follow-up among medication abortion clients in clinic visits in the United States.(42) However, given the restrictive legal and social environments in which the study took place, the accompaniment groups report that individuals who are lost to follow-up tend to be those with successful abortions who need no additional support, while those in need of information on accessing formal health care, or who experience a failed abortion, are more likely to stay in contact as they are often the only source of care or information for these people. Accompaniment groups report very few instances of complications being reported more than one month after a person takes the pills. Additional limitations include the different medication regimens and screening protocols used across sites, as well as the range of gestational ages. These limitations, however, are balanced by several key strengths, including the study design which allows prospective assessment of abortion experiences with a high degree of detail, as well as the range of settings and contexts covered by participants from the three countries. The generalizability of study results to other self-managed medication abortion settings may depend on the quality of information and counseling provided, and the medication protocols recommended.\u003c/p\u003e "},{"header":"Conclusions","content":"\u003cp\u003eFindings from this prospective, observational, multi-country pilot study are consistent with the hypothesis that self-managed medication abortion with accompaniment group support is safe and effective. These data will inform a larger, prospective, non-inferiority study to strengthen the findings presented here. These results offer a contribution to policy makers and professional bodies as they imminently consider revisions to task-shifting and other medication abortion provision guidelines, as well as if and how to support the de-medicalization of medication abortion services as healthcare infrastructures around the globe are challenged in unprecedented ways in the wake of a global pandemic.\u003c/p\u003e "},{"header":"List Of Abbreviations","content":"\u003cp\u003eDMOC—Data monitoring and oversight committee\u003c/p\u003e\n\u003cp\u003eWHO—World Health Organization\u003c/p\u003e \n"},{"header":"Declarations","content":"\u003ch2\u003eEthical approval and consent to participate\u003c/h2\u003e\n\u003cp\u003eThis study was approved by the Allendale Institutional Review Board (IRB), protocol number SAFE032019, in March 2019. Survey participants gave verbal consent to participate.\u003c/p\u003e\n\u003ch2\u003eConsent for publication\u003c/h2\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003ch2\u003eAvailability of data and materials.\u003c/h2\u003e\n\u003cp\u003eThe datasets generated during the current study are not publicly available due to concerns regarding confidentiality but are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003ch2\u003eFunding\u003c/h2\u003e\n\u003cp\u003eThis project was supported by a grant from the David and Lucile Packard Foundation.\u003c/p\u003e\n\u003ch2\u003eAuthorship contributions\u003c/h2\u003e\n\u003cp\u003eBG, BKO, CG, HM, IK, RJ, RM, RZ, SF and SN contributed to the quantitative study conceptualization and design, and HM, SR, and RJ conducted the quantitative analyses. HM led the writing of the manuscript, with contributions, review, and approval from all authors.\u003c/p\u003e\n\u003ch2\u003eAcknowledgements\u003c/h2\u003e\n\u003cp\u003eWe wish to thank Azul Alarcon, Amarachi Amaghiro, Ilana Dzuba, Inna Hudaya, Onikepe Owolabi, Tatyana Roberts, Mariana Romero, and Guillermina Peralta who contributed to this work, in various forms. We also wish to thank the study participants, who generously shared their time and personal experiences with data collectors.\u003c/p\u003e\n\u003ch2\u003eCompeting interests\u003c/h2\u003e\n\u003cp\u003eWe have no competing interests to declare.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eChemlal S, Russo G. Why do they take the risk? A systematic review of the qualitative literature on informal sector abortions in settings where abortion is legal. BMC Womens Health. 2019;19(1):55.\u003c/li\u003e\n\u003cli\u003eMoseson H, Herold S, Filippa S, Barr-Walker J, Baum SE, Gerdts C. 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Effectiveness of accompaniment of self-managed medication abortion in the second trimester: a retrospective review of case records from Argentina, Chile, and Ecuador Society for Family Planning Annual Meeting 2019; Los Angeles, CA2019.\u003c/li\u003e\n\u003cli\u003eGerdts C, Jayaweera RT, Kristianingrum IA, Khan Z, Hudaya I. Effect of a smartphone intervention on self-managed medication abortion experiences among safe-abortion hotline clients in Indonesia: A randomized controlled trial. Int J Gynaecol Obstet. 2020;149(1):48-55.\u003c/li\u003e\n\u003cli\u003eMohdin A. Relaxation of UK abortion rules welcomed by experts. The Guardian. 2020 March 30, 2020.\u003c/li\u003e\n\u003cli\u003eKapp N, Blanchard K, Coast E, Ganatra B, Harries J, Footman K, et al. Developing a forward-looking agenda and methodologies for research of self-use of medical abortion. Contraception. 2018;97(2):184-8.\u003c/li\u003e\n\u003cli\u003eCavallo J, Donoho D, Forman H. Hospital Capacity and Operations in the Coronavirus Disease 2019 (COVID-19) Pandemic\u0026mdash;Planning for the Nth Patient. JAMA Network. 2020.\u003c/li\u003e\n\u003cli\u003eTopol E. Telemedicine is essential amid the COVID-19 crisis and after it. The Economist. 2020 31 March 2020.\u003c/li\u003e\n\u003cli\u003eBriozzo L, Vidiella G, Rodriguez F, Gorgoroso M, Faundes A, Pons JE. A risk reduction strategy to prevent maternal deaths associated with unsafe abortion. Int J Gynaecol Obstet. 2006;95(2):221-6.\u003c/li\u003e\n\u003cli\u003eGrossman D, Baum SE, Andjelic D, Tatum C, Torres G, Fuentes L, et al. A harm-reduction model of abortion counseling about misoprostol use in Peru with telephone and in-person follow-up: A cohort study. PLoS One. 2018;13(1):e0189195.\u003c/li\u003e\n\u003cli\u003eEndler M, Beets L, Gemzell Danielsson K, Gomperts R. Safety and acceptability of medical abortion through telemedicine after 9 weeks of gestation: a population-based cohort study. BJOG. 2019;126(5):609-18.\u003c/li\u003e\n\u003cli\u003eStillman M, Owolabi O, Akinyemi A, Moore A, Bankole A, Fatusi A, et al. Women\u0026rsquo;s self-reported experiences using misoprostol obtained from drug sellers: a prospective cohort study in Lagos State, Nigeria. BMJ Open. 2020(IN PRESS).\u003c/li\u003e\n\u003cli\u003eBracken H, Clark W, Lichtenberg ES, Schweikert SM, Tanenhaus J, Barajas A, et al. Alternatives to routine ultrasound for eligibility assessment prior to early termination of pregnancy with mifepristone-misoprostol. BJOG. 2011;118(1):17-23.\u003c/li\u003e\n\u003cli\u003eClark WH, Gold M, Grossman D, Winikoff B. Can mifepristone medical abortion be simplified? A review of the evidence and questions for future research. Contraception. 2007;75(4):245-50.\u003c/li\u003e\n\u003cli\u003eRaymond EG, Harrison MS, Weaver MA. Efficacy of Misoprostol Alone for First-Trimester Medical Abortion: A Systematic Review. Obstet Gynecol. 2019;133(1):137-47.\u003c/li\u003e\n\u003cli\u003eRaymond EG, Tan YL, Comendant R, Sagaidac I, Hodorogea S, Grant M, et al. Simplified medical abortion screening: a demonstration project. Contraception. 2018;97(4):292-6.\u003c/li\u003e\n\u003cli\u003eSchonberg D, Wang LF, Bennett AH, Gold M, Jackson E. The accuracy of using last menstrual period to determine gestational age for first trimester medication abortion: a systematic review. Contraception. 2014;90(5):480-7.\u003c/li\u003e\n\u003cli\u003eAverbach S, Puri M, Blum M, Rocca C. Gestational dating using last menstrual period and bimanual exam for medication abortion in pharmacies and health centers in Nepal. Contraception. 2018;98(4):296-300.\u003c/li\u003e\n\u003cli\u003eAndersen K, Fjerstad M, Basnett I, Neupane S, Acre V, Sharma SK, et al. Determination of medical abortion eligibility by women and community health volunteers in Nepal: A toolkit evaluation. PLoS One. 2017;12(9):e0178248.\u003c/li\u003e\n\u003cli\u003eSchmidt-Hansen M, Cameron S, Lohr PA, Hasler E. Follow-up strategies to confirm the success of medical abortion of pregnancies up to 10 weeks' gestation: A systematic review with meta-analyses. Am J Obstet Gynecol. 2019.\u003c/li\u003e\n\u003cli\u003ePerriera LK, Reeves MF, Chen BA, Hohmann HL, Hayes J, Creinin MD. Feasibility of telephone follow-up after medical abortion. Contraception. 2010;81(2):143-9.\u003c/li\u003e\n\u003cli\u003evon Hertzen H, Piaggio G, Huong NTM, Arustamyan K, Cabezas E, Gomez M, et al. Efficacy of two intervals and two routes of administration of misoprostol for termination of early pregnancy: a randomised controlled equivalence trial. The Lancet. 2007;369(9577):1938-46.\u003c/li\u003e\n\u003cli\u003eFjerstad M, Sivin I, Lichtenberg ES, Trussell J, Cleland K, Cullins V. Effectiveness of medical abortion with mifepristone and buccal misoprostol through 59 gestational days. Contraception. 2009;80(3):282-6.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Appendix","content":"\u003ch2\u003e\u003cstrong\u003e\u003cu\u003eAppendix I: Medication Abortion Protocols as of March 2019 \u0026amp; Contraindications\u003c/u\u003e\u003c/strong\u003e\u003c/h2\u003e\n\u003ch2\u003e\u003cstrong\u003eSouth America\u003c/strong\u003e\u003c/h2\u003e\n\u003cp\u003e\u003cem\u003eMifepristone + Misoprostol for pregnancies up to 84 days: Oral/Sublingual\u003c/em\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eSwallow 1 tablet of mifepristone (200mg) with a glass of water\u003c/li\u003e\n\u003cli\u003eAfter 36-48 hours, put 4 pills of misoprostol (800mcg) under the tongue (sublingual) and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cem\u003eMifepristone + Misoprostol for pregnancies up to 84 days: Oral/Vaginal\u003c/em\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eSwallow 1 tablet of mifepristone (200mg) with a glass of water\u003c/li\u003e\n\u003cli\u003eAfter 36-48 hours, put 4 pills of misoprostol (800mcg) inside the vagina, fairly deep into the vagina. Rest for one hour with your legs up. (Before placing the pills, you can splash them with water.)\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cem\u003eContraindications\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIf a caller reports any of an: c-section within the past six months, ectopic pregnancy, chronic adrenal failure, long term corticosteroid therapy, intolerable known allergy to mifepristone or misoprostol, current use of IUD, or hemorrhagic disorders, or has not chosen to terminate the pregnancy of their own free will, the caller is deemed ineligible for medication abortion.\u003c/p\u003e\n\u003ch2\u003e\u003cstrong\u003eSouth East Asia\u003c/strong\u003e\u003c/h2\u003e\n\u003cp\u003e\u003cem\u003eMifepristone + Misoprostol for pregnancies up to 84 days\u003c/em\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eSwallow 1 tablet of mifepristone (200mg) with a glass of water\u003c/li\u003e\n\u003cli\u003eAfter 24 hours, put 4 pills of misoprostol (800mcg) under the tongue (sublingual) and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve.\u003c/li\u003e\n\u003cli\u003e\u003cstrong\u003e\u003cem\u003eIf no signs of reaction, side effects and expulsion has not occurred after 3 hours, \u003c/em\u003e\u003c/strong\u003eput 2 pills of misoprostol (400mcg) under the tongue (sublingual) and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve\u003cstrong\u003e\u003cem\u003e .\u003c/em\u003e\u003c/strong\u003e\u003c/li\u003e\n\u003cli\u003eTake 2 pills misoprostol the same way every 3 hours until the products of conception expel.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cem\u003eMisoprostol alone for pregnancies up to 84 days\u003c/em\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003ePut 4 pills of misoprostol (800mcg) under the tongue (sublingual) and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve. Wait for 3 hours.\u003c/li\u003e\n\u003cli\u003eIf no signs of reaction, side effects and expulsion has not occurred, after 3 hours, put add another 2 pills (400 mcg) the same way.\u003c/li\u003e\n\u003cli\u003eRepeat 2 pills the same way every 3 hours until when the product of conception expel.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cem\u003eMifepristone + Misoprostol for pregnancies beyond 84 days\u003c/em\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eSwallow 1 tablet of mifepristone (200mg) with a glass of water\u003c/li\u003e\n\u003cli\u003eAfter 24 hours, Put 2 pills of misoprostol (400mcg) under the tongue (sublingual) and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve. Wait for 3 hours.\u003c/li\u003e\n\u003cli\u003eRepeat 2 pills the same way every 3 hours and\u003cstrong\u003e stop \u003c/strong\u003ewhen the product of conception expelled.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cem\u003eMisoprostol only for pregnancies beyond 84 days\u003c/em\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eSwallow 1 tablet of mifepristone (200mg) with a glass of water\u003c/li\u003e\n\u003cli\u003eAfter 24 hours, Put 2 pills of misoprostol (400mcg) under the tongue (sublingual) and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve. Wait for 3 hours.\u003c/li\u003e\n\u003cli\u003eRepeat 2 pills the same way every 3 hours and\u003cstrong\u003e stop \u003c/strong\u003ewhen the product of conception expelled.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cem\u003eContraindications\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIf a caller reports any of the following: c-section within the past six months, ectopic pregnancy, chronic adrenal failure, long term corticosteroid therapy, intolerable known allergy to mifepristone or misoprostol, current use of IUD, or hemorrhagic disorders, the caller is deemed ineligible for medication abortion, but may still proceed with counselor and referral for surgical abortion services. Anyone who is not interested in terminating of their own free will is ineligible.\u003c/p\u003e\n\u003ch2\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eWest Africa\u003c/strong\u003e\u003c/h2\u003e\n\u003cp\u003eThe hotline in West Africa provides information to callers based on the WHO protocol for medication abortion:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eMisoprostol only for pregnancies up to 84 days\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e12 misoprostol pills of 200 mcg each (2400 mcg of misoprostol total)\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003ePut 4 pills (800mcg) under the tongue (sublingual) and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve. Wait for 3 hours.\u003c/li\u003e\n\u003cli\u003eAfter 3 hours, put the second dose of 4 pills (800 mcg) under the tongue and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve. Wait for 3 hours.\u003c/li\u003e\n\u003cli\u003eAfter 3 hours, put a third dose of 4 pills (800 mcg) under the tongue and let them dissolve for 30 minutes, keep swallowing saliva until the pills dissolve.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eMifepristone + Misoprostol for pregnancies up to 84 days\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e1 mifepristone tablet of 200 mg and 4 misoprostol tablets of 200 mcg each (800 mcg of misoprostol total)\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eSwallow 1 tablet of mifepristone (200mg) with a glass of water\u003c/li\u003e\n\u003cli\u003eAfter 24 hours, put 4 pills (800 mcg) of misoprostol between the gum and the cheek (buccal), two on the left side and two on the right side.\u003c/li\u003e\n\u003cli\u003eAll four pills should be left in the mouth for approximately 30 minutes to dissolve.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cem\u003eContraindications\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIf a caller reports any of: a current IUD, allergy to misoprostol, current sexually transmitted infection, an ectopic pregnancy, or has not chosen to terminate the pregnancy of their own free will, the caller is deemed ineligible for medication abortion.\u003c/p\u003e\n\u003ch2\u003e\u003cu\u003e\u003c/u\u003e\u003cstrong\u003e\u003cu\u003eAppendix 2. Self-managed medication abortion outcomes by gestational age\u003c/u\u003e\u003c/strong\u003e\u003c/h2\u003e\n\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd width=\"288\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"80\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026lt;8 weeks\u003cbr /\u003e n=141\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"67\"\u003e\n\u003cp\u003e\u003cstrong\u003e8-9 weeks\u003cbr /\u003e n=40\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"81\"\u003e\n\u003cp\u003e\u003cstrong\u003e10-12 weeks\u003cbr /\u003e n=16\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"72\"\u003e\n\u003cp\u003e\u003cstrong\u003e13-17 weeks\u003cbr /\u003e n=3\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"72\"\u003e\n\u003cp\u003e\u003cstrong\u003eGA missing\u003cbr /\u003e n=2\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"288\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"44\"\u003e\n\u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28\"\u003e\n\u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"39\"\u003e\n\u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"33\"\u003e\n\u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"22\"\u003e\n\u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"50\"\u003e\n\u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"18\"\u003e\n\u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"54\"\u003e\n\u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"288\"\u003e\n\u003cp\u003e\u003cstrong\u003eAbortion outcome\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"44\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"39\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"33\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"22\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"50\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"18\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"54\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"288\"\u003e\n\u003cp\u003eFelt abortion was complete\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e134\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"44\"\u003e\n\u003cp\u003e95.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28\"\u003e\n\u003cp\u003e37\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"39\"\u003e\n\u003cp\u003e92.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"33\"\u003e\n\u003cp\u003e16\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e100.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"22\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"50\"\u003e\n\u003cp\u003e100.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"18\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"54\"\u003e\n\u003cp\u003e100.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"288\"\u003e\n\u003cp\u003eFelt abortion was complete \u0026amp; no surgical intervention\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e133\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"44\"\u003e\n\u003cp\u003e94.3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28\"\u003e\n\u003cp\u003e36\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"39\"\u003e\n\u003cp\u003e90.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"33\"\u003e\n\u003cp\u003e15\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e93.8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"22\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"50\"\u003e\n\u003cp\u003e100.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"18\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"54\"\u003e\n\u003cp\u003e100.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"288\"\u003e\n\u003cp\u003eFelt unsure if abortion was complete\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"44\"\u003e\n\u003cp\u003e3.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"39\"\u003e\n\u003cp\u003e5.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"33\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e0.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"22\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"50\"\u003e\n\u003cp\u003e0.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"18\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"54\"\u003e\n\u003cp\u003e0.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"288\"\u003e\n\u003cp\u003eFelt abortion was NOT complete\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"44\"\u003e\n\u003cp\u003e1.4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"39\"\u003e\n\u003cp\u003e2.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"33\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e0.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"22\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"50\"\u003e\n\u003cp\u003e0.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"18\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"54\"\u003e\n\u003cp\u003e0.0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"288\"\u003e\n\u003cp\u003e\u003cem\u003eReported a miscarriage prior to taking pills\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e\u003cem\u003e2\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"44\"\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28\"\u003e\n\u003cp\u003e\u003cem\u003e0\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"39\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd width=\"33\"\u003e\n\u003cp\u003e\u003cem\u003e0\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"22\"\u003e\n\u003cp\u003e\u003cem\u003e0\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"50\"\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"18\"\u003e\n\u003cp\u003e\u003cem\u003e0\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"54\"\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"288\"\u003e\n\u003cp\u003e\u003cem\u003eLost to follow-up prior to taking pills\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"36\"\u003e\n\u003cp\u003e\u003cem\u003e11\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"44\"\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28\"\u003e\n\u003cp\u003e\u003cem\u003e7\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"39\"\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"33\"\u003e\n\u003cp\u003e\u003cem\u003e4\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"48\"\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"22\"\u003e\n\u003cp\u003e\u003cem\u003e1\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"50\"\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"18\"\u003e\n\u003cp\u003e\u003cem\u003e0\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"54\"\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"reproductive-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"reph","sideBox":"Learn more about [Reproductive Health](http://reproductive-health-journal.biomedcentral.com)","snPcode":"12978","submissionUrl":"https://submission.nature.com/new-submission/12978/3","title":"Reproductive Health","twitterHandle":"@Reprod_Health","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"abortion, accompaniment, Africa, mifepristone, misoprostol, self-managed abortion, South America, Southeast Asia","lastPublishedDoi":"10.21203/rs.3.rs-31998/v2","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-31998/v2","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003eTo evaluate the feasibility of conducting a prospective study to measure self-managed medication abortion outcomes, and to collect preliminary data on safety and effectiveness of self-managed medication abortion, we recruited callers to accompaniment groups (volunteer networks that provide counselling through the out-of-clinic medication abortion process by trained counselors over the phone or in-person).\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eIn 2019, we enrolled callers to three abortion accompaniment groups in three countries into a prospective study on the safety and effectiveness of self-managed medication abortion with accompaniment support. Participants completed up to five interview-administered questionnaires from baseline through six-weeks after taking the pills. Primary outcomes included: (1) the number of participants enrolled in a 30-day period, (2) the proportion that had a complete abortion; and (3) the proportion who experienced any warning signs of potential or actual complications.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003eOver the 30-day recruitment period, we enrolled 227 participants (95% of those invited), and retained 204 participants (90%) for at least one study follow-up visit. At the one-week follow-up, two participants (1%) reported a miscarriage prior to taking the pills, and 202 participants (89% of those enrolled and 99% of those who participated in the one-week survey) had obtained and taken the medications. Three weeks after taking the medications, 192 (95%) participants reported feeling that their abortion was complete. Three (1.5%) received a surgical intervention, two (1%) received antibiotics, and five (3%) other medications. Participants did not report any major adverse events.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eConclusion: \u003c/strong\u003eThese results establish the feasibility of conducting prospective studies of self-managed medication abortion in legally restrictive settings. Further, the high effectiveness of self-managed medication abortion with accompaniment support reported here is consistent with high levels of effectiveness reported in prior studies. \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eTrial Registration: \u003c/strong\u003eISRCTN95769543\u003cstrong\u003e \u003c/strong\u003e\u003c/p\u003e","manuscriptTitle":"Self-managed medication abortion outcomes: results from a prospective study","msid":"","msnumber":"","nonDraftVersions":[{"code":2,"date":"2020-09-04 02:18:54","doi":"10.21203/rs.3.rs-31998/v2","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Accept","date":"2020-09-29T12:00:00+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2020-09-22T12:00:00+00:00","index":2,"fulltext":"Recommendation: Accept\nForm responses:\n---\n\nComments to Author:\n---\nI have read your explanations to my review comments. I thank you for your thoroughly explanations and answers. However, noting thatsome of these questions and concerns may be shared by other people who would like to read and learn from your study, I suggest that you work on them. Thank you.* Publons Reviewer Recognition. Springer Nature can send verification of this review directly to Publons (a subsidiary of Clarivate Analytics). If you would like to take advantage of this service, please click on the “Yes” option below. Your name, email address, title of the reviewed manuscript, name of the journal, and date of your review submission (the “Review Data”) will then be transmitted to Publons upon publication of the manuscript. If you have already registered at Publons, they will notify you of the receipt of this review and update your profile as per your settings and their policy. If you are not registered with Publons, you will receive an email from them asking you to register in order for them to be able to recognize your review on your new profile page. Publons may use the Review Data to generate derivative metadata for the benefit of Publons and you as a reviewer, carefully considering the sensitivity of such information. For example, Publons may verify your record as a reviewer by updating your profile published on its webservice if you have registered for such service or help editors to identify candidate reviewers. Please find the details of processing in Publons’ privacy policy https://publons.com/about/terms: **Yes**\n* Level of interest: **An article of importance in its field**\n* Quality of written English: **Acceptable**\n* Declaration of competing interests: **I declare that I have no competing interests.**\n* I agree to the open peer review policy of the journal. I understand that my name will be included on my report to the authors and, if the manuscript is accepted for publication, my named report including any attachments I upload will be posted on the website along with the authors' responses. I agree for my report to be made available under an Open Access Creative Commons CC-BY license (http://creativecommons.org/licenses/by/4.0/). I understand that any comments which I do not wish to be included in my named report can be included as confidential comments to the editors, which will not be published.: **\nI agree to the open peer review policy of the journal**\n"},{"type":"reviewerAgreed","content":"","date":"2020-09-18T12:00:00+00:00","index":2,"fulltext":""},{"type":"editorInvitedReview","content":"","date":"2020-09-03T12:00:00+00:00","index":1,"fulltext":"Recommendation: Accept\nForm responses:\n---\n\nComments to Author:\n---\nThe authors have addressed all my concerns point-by-point and made a sound revision. The manuscript is now greatly improved, most of the suggestions are included, and other issues are satisfactorily justified. I feel this manuscript is well written, and technically and methodologically acceptable for publication.* Publons Reviewer Recognition. Springer Nature can send verification of this review directly to Publons (a subsidiary of Clarivate Analytics). If you would like to take advantage of this service, please click on the “Yes” option below. Your name, email address, title of the reviewed manuscript, name of the journal, and date of your review submission (the “Review Data”) will then be transmitted to Publons upon publication of the manuscript. If you have already registered at Publons, they will notify you of the receipt of this review and update your profile as per your settings and their policy. If you are not registered with Publons, you will receive an email from them asking you to register in order for them to be able to recognize your review on your new profile page. Publons may use the Review Data to generate derivative metadata for the benefit of Publons and you as a reviewer, carefully considering the sensitivity of such information. For example, Publons may verify your record as a reviewer by updating your profile published on its webservice if you have registered for such service or help editors to identify candidate reviewers. Please find the details of processing in Publons’ privacy policy https://publons.com/about/terms: **Yes**\n* Level of interest: **An article of importance in its field**\n* Quality of written English: **Acceptable**\n* Declaration of competing interests: **I declare that I have no competing interests.**\n* I agree to the open peer review policy of the journal. I understand that my name will be included on my report to the authors and, if the manuscript is accepted for publication, my named report including any attachments I upload will be posted on the website along with the authors' responses. I agree for my report to be made available under an Open Access Creative Commons CC-BY license (http://creativecommons.org/licenses/by/4.0/). I understand that any comments which I do not wish to be included in my named report can be included as confidential comments to the editors, which will not be published.: **\nI agree to the open peer review policy of the journal**\n"},{"type":"reviewerAgreed","content":"","date":"2020-09-02T12:00:00+00:00","index":1,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2020-09-01T12:00:00+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2020-08-30T12:00:00+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2020-08-29T12:00:00+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2020-08-29T12:00:00+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"reproductive-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"reph","sideBox":"Learn more about [Reproductive Health](http://reproductive-health-journal.biomedcentral.com)","snPcode":"12978","submissionUrl":"https://submission.nature.com/new-submission/12978/3","title":"Reproductive Health","twitterHandle":"@Reprod_Health","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}},{"code":1,"date":"2020-06-04 16:12:53","doi":"10.21203/rs.3.rs-31998/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2020-07-31T12:00:00+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2020-06-29T12:00:00+00:00","index":3,"fulltext":"Recommendation: Reviewer's comments unavailable pending editorial decision\n"},{"type":"editorInvitedReview","content":"","date":"2020-06-28T12:00:00+00:00","index":2,"fulltext":"Recommendation: Minor Revision\nForm responses:\n---\n\nComments to Author:\n---\n\nTitle: Self-managed medication abortion outcomes: results from a prospective study\nGeneral comment\nIt is an original, scientifically sound, and well-written manuscript. Minor revision on method and result is required.\nSpecific comments\nAbstract\nI suggest including the response rate or follow-up success rate under the result. I think it is important like other study outcomes.\nBackground\nPage 2, L3-34: The background seems about the method of study. it is almost included in the next paragraph(Method). I would rather recommend you include why the study is important. Is abortion a problem in the study areas?\nMethod\nWhat is the tool used for data entry and data analysis? Please add what tools used, how was data entered, and analyzed. What is your justification to choose the study areas/countries?\nPage 10, L190: One of the inclusion criteria was \"being at least 13 years of age\". Is this the minimum age requirement to get consent according to the legal and ethical guidelines of the specific countries? In most countries the age range for adulthood and to give consent is 18 and above while in other countries age 15 and above is eligible to give consent if the participant is married and/or independent. Did you take consent or assent? If you take assent, how about the disclosure issues? Abortion is a sensitive issue and needs privacy and confidentiality. I think you need to justify it under the ethical consideration section.\nL199-201: 'Callers of any gestational age were eligible to participate in the study'. This inclusion criterion is contradicting medication abortion indication which is indicated only for less than 9 weeks of GA, rarely it might be indicated for up to 12 weeks. I see you have three participants with GA of 13-17 weeks and two with missed GA but they have taken Self-Medication abortion(Appendix 2). Luckily all had complete abortions. However, it is risky to use medication abortion after the first trimester(12 weeks) or for unknown GA. WHO recommends up to 24 weeks for clinic setting but the safety for home-based is left open. Do you think Self-Medication is safe for those in their 2nd trimester? Please justify why you include such participants. What do you recommend for other home-based users regarding their GA?\nDeclaration\nPage 20, L412: I think, Ethical consideration should be one section, maybe just next to the method and before the result section. It should be detailed enough to include all the ethical approval processes that you have done. This is a multi-country study that you have to get ethical approval from each involved country. Since this study includes teenagers (13 years and above), there are ethical issues regarding consent unless and otherwise clearly stated how the minorities were approached. \nTable 1: What is the rationale for the age categories you have used? there is no equal range among the age groups. 18-19?\nWith respect to age, the total participant number is 228, not 227. Please make sure your data is reliable and consistent.\nTable 3. The first Column(under Total n=202) is not clear. I expect the total to be 202 for each question except the last one where participants can select more than one answer. Because I understand that total is to mean both Mife + Miso and Miso regimens. Therefore, the total should be the sum of these two columns. Again, check your numbers.\nThe title for some tables is too long(E.g. Table 4). You can make it shorter; the explanation is already included in the method section.\n* Publons Reviewer Recognition. Springer Nature can send verification of this review directly to Publons (a subsidiary of Clarivate Analytics). If you would like to take advantage of this service, please click on the “Yes” option below. Your name, email address, title of the reviewed manuscript, name of the journal, and date of your review submission (the “Review Data”) will then be transmitted to Publons upon publication of the manuscript. If you have already registered at Publons, they will notify you of the receipt of this review and update your profile as per your settings and their policy. If you are not registered with Publons, you will receive an email from them asking you to register in order for them to be able to recognize your review on your new profile page. Publons may use the Review Data to generate derivative metadata for the benefit of Publons and you as a reviewer, carefully considering the sensitivity of such information. For example, Publons may verify your record as a reviewer by updating your profile published on its webservice if you have registered for such service or help editors to identify candidate reviewers. Please find the details of processing in Publons’ privacy policy https://publons.com/about/terms: **Yes**\n* Level of interest: **An article of importance in its field**\n* Quality of written English: **Acceptable**\n* Declaration of competing interests: **I declare that I have no competing interests**\n* I agree to the open peer review policy of the journal. I understand that my name will be included on my report to the authors and, if the manuscript is accepted for publication, my named report including any attachments I upload will be posted on the website along with the authors' responses. I agree for my report to be made available under an Open Access Creative Commons CC-BY license (http://creativecommons.org/licenses/by/4.0/). I understand that any comments which I do not wish to be included in my named report can be included as confidential comments to the editors, which will not be published.: **\nI agree to the open peer review policy of the journal**\n"},{"type":"editorInvitedReview","content":"","date":"2020-06-28T12:00:00+00:00","index":1,"fulltext":"Recommendation: Major Revision\nForm responses:\n---\n\nComments to Author:\n---\nDear Author, first of all I would like to appreciate your deep understanding of the problem and your wisdom on research. However, I have noticed the following challenges in this particular study:\n1) If we start from the very concept of Pilot study and its application. This study used a pilot study to assess safety of an intervention. This is one of the misuses of pilot study. We can not use pilot study for assessing safety on interventions.\n2) Although you have secured ethical clearance for this research, I noted that there is a serious ethical violation by this research. For example, in a country where abortion is illegal, administration of self-managed abortion with accompaniment model may not be acceptable. The other thing is the model lacks some medical interventions that need physical examination of the client. Virtual examination of eligibility of a pregnant women for abortion is incomplete. They also need some physical and biomedical exam. How do you assess eligibility including if the client gets bleeding problem ? What if the client dies because of these unforeseen medical problems?\n3) Without any inferential / advanced statistics done, it is difficult to come up with those conclusions in your report.\n4) Your conclusion of effectiveness is not objectively presented and is not convincing.\n5) please re-write the paragraph on 'physical experience of self-managed....\n* Publons Reviewer Recognition. Springer Nature can send verification of this review directly to Publons (a subsidiary of Clarivate Analytics). If you would like to take advantage of this service, please click on the “Yes” option below. Your name, email address, title of the reviewed manuscript, name of the journal, and date of your review submission (the “Review Data”) will then be transmitted to Publons upon publication of the manuscript. If you have already registered at Publons, they will notify you of the receipt of this review and update your profile as per your settings and their policy. If you are not registered with Publons, you will receive an email from them asking you to register in order for them to be able to recognize your review on your new profile page. Publons may use the Review Data to generate derivative metadata for the benefit of Publons and you as a reviewer, carefully considering the sensitivity of such information. For example, Publons may verify your record as a reviewer by updating your profile published on its webservice if you have registered for such service or help editors to identify candidate reviewers. Please find the details of processing in Publons’ privacy policy https://publons.com/about/terms: **Yes**\n* Level of interest: **An article of importance in its field**\n* Quality of written English: **Acceptable**\n* Declaration of competing interests: **I declare that I have no competing interest**\n* I agree to the open peer review policy of the journal. I understand that my name will be included on my report to the authors and, if the manuscript is accepted for publication, my named report including any attachments I upload will be posted on the website along with the authors' responses. I agree for my report to be made available under an Open Access Creative Commons CC-BY license (http://creativecommons.org/licenses/by/4.0/). I understand that any comments which I do not wish to be included in my named report can be included as confidential comments to the editors, which will not be published.: **\nI agree to the open peer review policy of the journal**\n"},{"type":"reviewerAgreed","content":"","date":"2020-06-20T12:00:00+00:00","index":2,"fulltext":""},{"type":"reviewerAgreed","content":"","date":"2020-06-20T12:00:00+00:00","index":3,"fulltext":""},{"type":"reviewerAgreed","content":"","date":"2020-06-19T12:00:00+00:00","index":1,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2020-06-18T12:00:00+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2020-06-08T12:00:00+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2020-06-07T12:00:00+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2020-05-30T12:00:00+00:00","index":"","fulltext":""},{"type":"submitted","content":"","date":"2020-05-28T12:00:00+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"reproductive-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"reph","sideBox":"Learn more about [Reproductive Health](http://reproductive-health-journal.biomedcentral.com)","snPcode":"12978","submissionUrl":"https://submission.nature.com/new-submission/12978/3","title":"Reproductive Health","twitterHandle":"@Reprod_Health","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"3131dbfa-dd3b-456e-bb3a-a7b7bbec7a75","owner":[],"postedDate":"September 4th, 2020","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":113399,"name":"Sexual \u0026 Reproductive Medicine"}],"tags":[],"updatedAt":"2020-11-01T15:04:18+00:00","versionOfRecord":{"articleIdentity":"rs-31998","link":"https://doi.org/10.1186/s12978-020-01016-4","journal":{"identity":"reproductive-health","isVorOnly":false,"title":"Reproductive Health"},"publishedOn":"2020-10-27 15:02:57","publishedOnDateReadable":"October 27th, 2020"},"versionCreatedAt":"2020-09-04 02:18:54","video":"","vorDoi":"10.1186/s12978-020-01016-4","vorDoiUrl":"https://doi.org/10.1186/s12978-020-01016-4","workflowStages":[]},"version":"v2","identity":"rs-31998","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-31998","identity":"rs-31998","version":["v2"]},"buildId":"GqpaHPwrfC8PjnIFayRh5","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}