Self-managed medical abortion in Nigeria: A prospective, comparative study of clinical outcomes for a misoprostol-alone regimen obtained from patent medicine vendors compared to clinics

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Shellenberg, Risa Griffin, Simone Storey, Nkiruka Okwesa, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7652351/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 26 Mar, 2026 Read the published version in Reproductive Health → Version 1 posted You are reading this latest preprint version Abstract Background To determine whether important clinical outcomes differ among women who access misoprostol alone from a PMV when compared with those who access it from a clinic. Methods We conducted a prospective, comparative cohort study of women aged 15-49 accessing a misoprostol-alone regimen from clinics and PMVs in three states of Nigeria. Women were recruited at the point of accessing misoprostol at a clinic or PMV. Follow-up by telephone to confirm pill use and access clinical outcomes at three to seven days, 10-29 days, and 30-45 days after taking misoprostol. Results Over 11 months, we enrolled 1835 women, and complete data was available from 1572 women (824 from clinics and 748 from PMVs). The rate of additional treatment to complete the abortion was non-inferior for the pharmacy group (3.6%) compared with the clinic cohort (9.5%). Although a small proportion of women in each cohort reported visiting a health care professional after taking misoprostol, no complications were reported. Most women felt prepared for what would happen after the misoprostol (92% of both cohorts) and would recommend medical abortion to a friend (89% of the clinic cohort and 90% of the PMV cohort). Conclusions Self-managed abortion with misoprostol alone from PMVs was comparable in safety, effectiveness, and acceptability to clinic-based care, in line with global evidence supporting self-management of abortion care. Trial Registration Retrospectively registered at ClinicalTrials.gov ID NCT04242212 Nigeria abortion misoprostol abortion pills misoprostol alone medical abortion medication abortion patent medicine vendors pharmacy clinics Figures Figure 1 PLAIN ENGLISH SUMMARY Unsafe abortion remains a major public health issue in Nigeria. Restrictive abortion laws and limited access to contraception mean that many abortions happen outside the formal healthcare system, often under unsafe conditions. This study examined whether women’s clinical outcomes differed when they obtained abortion pills from a clinic compared to a patient medicine vendor (PMV). PMVs are drug sellers who lack formal pharmaceutical training but are allowed to sell certain medicines. We followed 1,572 women across three states in Nigeria who received abortion pills from either a clinic or a PMV. We found that self-managed abortion with pills received from PMVs can be as safe, effective, and acceptable as clinic-based provision for pregnancies under nine weeks. This finding supports global evidence that medication abortion can be managed successfully outside of clinical settings, even in restrictive contexts like Nigeria, where abortion services and post-abortion care are limited. Many women rely on PMVs to access abortion medication, and this study highlights the role they can play in expanding access to safe abortion in Nigeria. BACKGROUND Unsafe abortion is a major public health issue in Nigeria, where the high unmet need for contraception and restrictive abortion law results in many abortions occurring outside the formal healthcare system and often under unsafe conditions ( 1 ). Despite the country’s stringent legal framework, induced abortion is commonly practiced and a 2018 population-based survey estimated a 1-year abortion incidence of 29.0 per 1000 women aged 15–49, while the confidante method yielded a higher estimate of 45.8 per 1000 and considered closer to reality ( 2 ). The majority of these abortions were classified as ‘most unsafe’ and were more common among younger, uneducated, rural, and poor women. Unsafe abortion and related complications contribute substantially to maternal morbidity and mortality in Nigeria ( 3 ). Furthermore, many women may not seek post-abortion care due to concerns about confidentiality and lack of trust in the availability of services ( 4 ). In 2019, only 20% of primary-level facilities in Nigeria were estimated to be adequately equipped and staffed to provide post-abortion care ( 5 ). In this context, self-managed medical abortion (MA) offers a safe, non-surgical option for terminating early pregnancies. The World Health Organization (WHO) recommends two medication regimens: a combination of mifepristone followed by misoprostol, or misoprostol alone ( 6 ). While the combined regimen is highly effective, the misoprostol-alone regimen is widely used, especially in low-resource or legally restrictive settings ( 7 ). Misoprostol is more accessible because it has several indications beyond MA, such as management of miscarriage or postpartum hemorrhage ( 8 ). The use of misoprostol alone is an effective and safe option ( 9 ). The WHO also recommends self-management of MA up to 12 weeks’ gestation by the pregnant person themselves as well as management by various health professionals, including pharmacy workers, pharmacists, and traditional medicine professionals ( 6 ). In Nigeria, misoprostol is increasingly used for abortion outside the formal healthcare system and is associated with fewer complications than other informal methods ( 10 ). A 2020 national survey found that 30% of abortion seekers used pharmacies or patent medicine vendors (PMVs) to obtain misoprostol, primarily due to their affordability and proximity compared to clinics or hospitals ( 11 ). PMVs are more commonly used than pharmacies, particularly by women with lower purchasing power, while pharmacies are more likely to be accessed by women with higher levels of education ( 12 ). Among a sample of Nigerian pharmacies and PMVs, 51% offered abortion pills with 68% of those only stocking misoprostol, making the misoprostol-alone regimen more widely accessible ( 13 ). While drug sellers in PMVs are viewed as trusted providers of abortion medication and information, they do not always provide the correct regimen and dosing instructions or adequate guidance on potential complications ( 13 , 14 ). Less than a third of sampled facilities in Nigeria provided correct MA instructions and discussed excessive bleeding as a warning sign ( 13 ). Nevertheless, even with limited knowledge of misoprostol and how the drug works, most women have been found to safely and successfully self-manage their abortion ( 15 ). This was also evident during the COVID-19 pandemic, when many women were still able to safely complete their abortion despite increased barriers to care ( 16 ). Growing evidence supports the safety and effectiveness of self-managed abortions across a range of settings. In Nepal, provision of the combined regimen of mifepristone and misoprostol by trained auxiliary nurse-midwives at pharmacies was found to be non-inferior to care at government facilities ( 17 ). Similarly, studies in Cambodia and Ghana found that pharmacy provision of the combined regimen with no direct provider interaction was non-inferior to clinic-based services ( 18 , 19 ). Meanwhile, in Argentina and Nigeria, a combined or misoprostol-alone regimen in conjunction with an accompaniment model (where people self-source medication and receive evidence-based information and support) was also found to be non-inferior to the documented effectiveness of MA measured in clinical settings ( 20 ). However, there is limited empirical evidence from Nigeria directly comparing clinical outcomes between women who obtain misoprostol from PMVs and those who access clinic-based care. Given the high demand for abortion services and barriers to formal care, it is valuable to understand how and where women access MA and if their clinical outcomes differ across these settings. This study aims to determine whether important clinical outcomes differ among women who access misoprostol from a PMV when compared with those who access it from a clinic. METHODS Study design We conducted a prospective, comparative cohort study of women aged 15–49 receiving a misoprostol-alone regimen for medical abortion from clinics and PMVs in three states in Nigeria. The primary outcome of interest was additional treatment to complete the abortion within 30 days of using misoprostol. Additional treatment was defined as reporting more than three doses of misoprostol and/or having a surgical procedure after taking at least one dose of misoprostol. A dose was defined as 800 micrograms of misoprostol. Secondary outcomes of interest included confidence that the abortion was complete at 30 days, serious abortion-related complications (defined as a hemorrhage requiring a blood transfusion, hospitalization, serious infection, and undiagnosed ectopic pregnancy), and a woman’s medical abortion experience. All outcomes were measured based on participant self-report. The required sample size calculation was based upon a non-inferiority design and assumed 80% power to detect a 4-percentage point difference in the primary outcome between the two cohorts, an alpha of 0.05, rho of 0.004, and 20% loss to follow-up by 45-days post-abortion. A four-percentage point difference was chosen to align with other similar studies being conducted at the time ( 18 , 19 ), and although a rho of 0.001 is acceptable based on prior research, we increased it to 0.004 to be conservative ( 17 ). This resulted in a required sample size of 4,032 participants from 40 sites, 2,016 from PMV sites and 2,016 from clinics. The National Health Research Ethics Committee in Nigeria approved the research protocol for this study (NREC/01/010/2007), and the study was retrospectively registered on clinicaltrials.gov (NCT04242212). Participant recruitment and data collection From May 2019 through April 2020, women were recruited and enrolled in person, by a trained research assistant, at the point of obtaining misoprostol from a clinic or PMV. We partnered with a total of 102 study sites in Anambra, Ogun, and Oyo, 67 PMVs and 35 clinics. To be eligible for participation, women had to have a known last menstrual period (LMP) of less than 9 weeks, have no known contraindications to misoprostol, be able to give informed consent, and have a mobile phone on which they could be safely reached during the follow-up period. Eligible participants were followed up by phone three to seven days after purchase/provision of misoprostol to confirm pill use, and then again at two time points, 10–29 days, and 30–45 days after taking the first dose of misoprostol to assess clinical outcomes. In total, four surveys were completed with participants: a baseline recruitment survey (in-person) and three follow-up surveys (done by phone). During the first follow-up survey (at 3–7 days after purchasing misoprostol), women were asked to report on the number of doses taken, number of pills taken per dose, route of administration, and timing between doses. During the second and third follow-up calls, women were asked whether they had received additional treatment to complete the abortion in the form of more pills or a surgical procedure like manual vacuum aspiration (MVA). If they said yes, additional treatment details were collected. During the second and third follow-up calls, women were also asked, “Since taking the medical abortion pills, did you get treatment from a health care professional for any other problems? The participant’s response triggered a series of questions intended to capture serious abortion-related complications. During the second and third follow-up surveys, women were also asked, “Do you think you are still pregnant?”. This served as a proxy measure for abortion completeness. During the third follow-up survey, women were asked a series of questions about their medical abortion experience. Participants received remuneration in the form of mobile phone credits for each follow-up call, totaling approximately 16 US dollars. All data were collected on secure Android tablets using the Dimagi CommCare cloud-based survey management system. Statistical analysis Descriptive analyses were conducted for sociodemographic characteristics, MA characteristics, additional treatment to complete the abortion, and MA experience. For categorical variables, frequencies and percentages are presented by study site type (clinic or PMV). Bivariate analysis compared percentages or means by study site type, and reported p-values are adjusted for clustering of responses by study site. For continuous variables, means and standard deviations are presented by study site type and t-tests were used to detect differences. For the non-inferiority analysis, we computed crude risk differences in outcomes by group (clinic versus PMV) using bivariate Poisson generalized estimating equations (GEE) models that account for clustering by recruitment site; these models were chosen because they perform well in simulation studies of multi-center trials with binary outcome data ( 21 ). The adjusted risk difference was calculated by including in the models the socio-demographic and reproductive characteristics that were significantly different between groups (age, education, occupation, marital status, and parity). We calculated 95% confidence intervals on the crude and adjusted risk differences, and if the confidence interval did not cross the non-inferiority limit of 4%, we considered PMVs non-inferior to clinics in terms of additional treatment to complete the abortion. We assessed differences in abortion experience by group, including preparedness for the medical abortion process and whether the participant would recommend medical abortion to a friend, using multilevel mixed effects models including random effects for sites. Cases with missing primary outcome data were excluded from this analysis. Missing data (i.e., responses of refused or don’t know) for other variables were imputed to the mean. Statistical significance was defined as an alpha of 0.05 or less, and all p-values are adjusted for clustering at the site level. All analyses were conducted using Stata version 16 (StataCorp) ( 22 ). RESULTS Eligibility and enrollment Over a period of 11 months, 1,843 women (1,004 from clinics and 839 from PMVs) were assessed for eligibility. Of those women, 1,835 (1,000 from clinics and 835 from PMVs) provided baseline information and consented to be followed up by phone. At survey one, we enrolled 1,711 women (928 from clinics and 783 from PMVs) who confirmed taking misoprostol. For the analyses, we included the 1,572 women (824 from clinics and 748 from PMVs) with complete data on the primary outcome. The flow of participants through the study is detailed in Fig. 1 . The lost to follow-up (LTFU) rate among enrolled individuals was 8% (11% from clinics and 4% from PMVs). Although we did not achieve the desired sample size of 2,016 women per cohort, our LTFU was significantly lower than anticipated, thereby resulting in the study still being powered at 80% to detect a 4-percentage point difference in the primary outcome between the two cohorts. Sociodemographic and reproductive history characteristics Several sociodemographic characteristic differences emerged between the two cohorts (Table 1). Participants in the clinic cohort were slightly younger, had less formal education, engaged in more manual labor, and were less likely to be married. In terms of reproductive histories, no significant differences existed between the two cohorts for gravidity, previous abortion, or type of previous abortion; women in the clinic cohort were less likely to have previously given birth (Table 1). Medical abortion characteristics Most women were less than eight weeks pregnant at baseline and used either Miso-Fem or Misoclear branded products, with women getting pills at clinics being more likely to be given Misoclear (Table 2). Almost ninety-four percent of women took one, two or three doses of misoprostol. Although we found no statistically significant difference between the cohorts, only 25% of women reported taking the misoprostol in alignment with the WHO recommended regimen (defined as 4 pills (200 micrograms each), vaginally, in-cheek or under the tongue), with 3 hours between doses). Additional treatment to complete the abortion (primary outcome) The rate of additional treatment to complete the abortion was 9.5% (n = 78) in the clinic cohort and 3.6% (n = 27) in the PMV cohort for a crude risk difference of -5.9%. Adjusting for age, education, occupation, marital status, and parity, the risk difference was − 6.2%, indicating non-inferiority of the PMV cohort to the clinic cohort (Table 3). Abortion completeness (secondary outcome) At survey two (10–29 days post-misoprostol) or survey three (30–45 days post-misoprostol) 92.8% (n = 1398) of women reported confidence that the abortion was complete, 93.1% (n = 713) among the clinic cohort and 92.6% (n = 685) among the PMV cohort for a crude risk difference of 0.9%. After adjusting for characteristic differences between the clinic and PMV cohorts, the adjusted risk difference (0.6%) was not significantly different between cohorts (Table 3). Complications (secondary outcome) Although a small proportion of women in each cohort reported visiting a health care professional at some point between day 10 and day 45 post-misoprostol (Table 3), the difference was not significant between the cohorts. No study participants reported a hemorrhage requiring a blood transfusion, hospitalization, serious infection, or an undiagnosed (at the time of taking misoprostol) ectopic pregnancy. Medical abortion experience (secondary outcome) The medical abortion experiences between the two cohorts were quite similar, with almost 92% (n = 1572) of women feeling prepared for what would happen after taking the pills (Table 4). A small proportion of women (n = 129) reported experiencing a symptom or side effect that was unexpected, including more pain, nausea, and vomiting, but there were no differences between the groups for most variables. Women from the PMV group were significantly more likely to report experiencing heavier bleeding than expected (p = 0.028). The acceptability of a woman’s MA experience was measured by whether the participant would recommend medical abortion to a friend. The response was similar between the groups, with 89% (n = 736) of the clinic cohort and 90% (n = 670) of the PMV cohort reporting that they would recommend MA to a friend (Table 4). A very small minority of women (1%) stated that they would not recommend any type of abortion to a friend. DISCUSSION Participants who obtained misoprostol for MA directly from PMVs in Nigeria without prior consultation with a trained provider experienced comparable clinical outcomes in terms of safety, effectiveness, and acceptability as those who accessed misoprostol through clinic-based care for pregnancies under nine weeks’ gestation. These findings build on the body of evidence showing that MA can be managed successfully outside of clinical settings, even in contexts where abortion-related mortality is high and additional support is limited ( 17 – 20 ). As in similar studies in Cambodia and Ghana, overall additional treatment rates to complete the abortion were low between those who obtained misoprostol from PMVs or accessed clinic-based care ( 18 , 19 ). While not a significant difference, all of these studies observed that additional treatment to complete the abortion was more common in the clinic group than the PMV or pharmacy group. This may be explained by participants in the clinic group having more familiarity with the clinical setting and finding it easier to access clinic-based care, whereas participants in the PMV group may have faced similar challenges to seeking additional treatment as initially seeking misoprostol from a clinical setting ( 19 ). Similar to participants in Cambodia, demographic differences were seen between the PMV and clinic groups ( 19 ). Participants in the clinic group tended to be younger, less educated, unmarried, and less likely to have previously given birth, which may also explain why they were more likely to seek additional treatment than participants in the PMV group which may have been more experienced. A small proportion visited a healthcare professional for other treatment with no statistically significant difference between groups, consistent with findings in Cambodia, Ghana, and Nepal ( 17 – 19 ). However, there were also some differences between the current study and those previously conducted in Cambodia and Ghana. We found a much higher confidence that the abortion was complete in both the clinic and PMV groups compared to those in Cambodia and Ghana, which was more aligned with the high confidence observed in similar studies in Nepal, Argentina, and Nigeria ( 17 , 20 ). Participants in both groups reported no complications or ectopic pregnancies, contrasting with a few complications and one ectopic pregnancy in both pharmacy groups reported in Cambodia and Ghana ( 18 , 19 ). The current study also found higher acceptability than those in Cambodia and Ghana with most participants in both groups willing to recommend MA to a friend and only 1% overall would not recommend abortion at all ( 18 , 19 ). Interestingly, we observed a much lower adherence with only 25% of all participants following the WHO recommended MA dosing regimen, compared to almost all participants in Cambodia and 87% of participants in Ghana taking the medication correctly ( 18 , 19 ). Furthermore, heavier bleeding than expected was experienced by 40% of participants in the PMV group, significantly more than those who access clinic-based care. Given the known lack of accurate and complete instructions provided by drug sellers, this may explain why so many participants did not follow the correct regimen and did not expect heavy bleeding ( 13 ). Nevertheless, the majority of participants reported feeling prepared for what would happen after taking the misoprostol and were able to safely and successfully self-manage their abortion, echoing previous findings in Nigeria ( 15 ). An important limitation to this study is that data for all outcomes were self-reported and unconfirmed by medical records or providers’ diagnoses. To address this, we chose an objective primary outcome of additional treatment to complete the abortion. While we relied on self-reported gestational age and confidence that the abortion was complete, evidence supports that reporting last menstrual period and self-assessing the success of the abortion are comparable to ultrasound assessment ( 23 ). A further limitation may be the generalizability of these findings in settings with more barriers to clinical support for additional treatment or to women purchasing misoprostol above nine weeks’ gestation. A key strength of this study is demonstrating the effectiveness of self-managed MA using the misoprostol-alone regimen. While similar studies have shown the combination regimen with quality-assured commodities or the misoprostol-alone regimen with accompaniment support, our results show that misoprostol alone, sourced from a range of brands and taken without direct provider oversight, was effective and comparable to clinic-based provision. This is a valuable contribution to the literature on self-managed abortion, particularly in restrictive settings, and aligns with WHO guidance ( 6 ). Additionally, our low LTFU supported internal validity and maintained the study’s power, despite a lower sample size than initially targeted. While the current study demonstrates self-managed MA with misoprostol-alone regimens obtained from PMVs to be safe and effective with similar clinical outcomes to clinic-provision, it also highlights the opportunity to improve the quality of information provision by drug sellers to adequately prepare women on how to take the medication, what to expect, and when to potentially seek additional treatment. We support existing recommendations to develop the technical competency of drug sellers to better support women self-managing their abortions ( 14 ). Aligned with previous findings, the capacity to provide post-abortion care should also be developed in primary-level facilities ( 5 ). Future research should further examine the use of misoprostol-alone regimens in other restrictive settings and explore strategies to improve access, support, and accurate use. CONCLUSIONS This study shows that self-managed abortion with misoprostol alone obtained from PMVs can be as safe, effective, and acceptable as clinic-based provision for pregnancies under nine weeks’ gestation in Nigeria. Self-management offers a valuable pathway to expanding access to safe abortion, especially in restrictive settings, but improving drug sellers’ competency to provide accurate information is essential to maximize safety and effectiveness. ABBREVIATIONS GEE Generalized estimating equations LMP Last menstrual period LTFU Loss to follow up MVA Manual vacuum aspiration MA Medical abortion PMV Patent medicine vendor Declarations The ethical approval board (NHREC) granted the research a waiver of parental consent given that young women are often excluded from studies about abortion outcomes. A revised statement could say" "All research participants were guided through an informed consent process and provided written informed consent by digitally signing their name on the tablet being used for data collection. The ethical review board granted this research a waiver of parental consent for women age 15-17 given that young women are often excluded from studies about abortion outcomes. Participants were provided with a paper copy of the informed consent if desired." Ethics approval and consent to participate The National Health Research Ethics Committee in Nigeria approved the research protocol for this study (NREC/01/010/2007). Informed consent was provided by all study participants, and all research was conducted in accordance with the Declaration of Helsinki. Consent for publication Not applicable. Competing interests We declare no competing interests. Funding This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The study was funded internally at Ipas, and Ipas had a direct role in the study design, data collection, data analysis, data interpretation, and writing of the manuscript. Author Contribution KMS conceptualized and led the study. BA and AO provided study oversight. NO was responsible for study administration and supervision. RG managed the data and conducted the analysis. KMS, RG, and SS lead the manuscript writing. All authors critically reviewed and edited the manuscript. Acknowledgement We thank Natalie Kapp for serving as a technical advisor on this study. We thank Erin Pearson for reviewing our data and providing feedback on the analysis. We thank Lucky Palmer for his support with this study. Also, we would like to thank all the women who shared their abortion experience information with us, and all the clinicians, patent medicine vendors, and research assistants who supported the data collection efforts. Data Availability The datasets generated and/or analyzed during the current study are not publicly available due the sensitive nature of abortion provision in Nigeria, but can be made available from the corresponding author on reasonable request. References Akande OW, Adenuga AT, Ejidike IC, Olufosoye AA. Unsafe abortion practices and the law in Nigeria: time for change. Sex Reproductive Health Matters. 2020;28(1):1758445. Suzanne OB, Elizabeth O, Funmilola O, Mridula S, Caroline M. Inequities in the incidence and safety of abortion in Nigeria. BMJ Global Health. 2020;5(1):e001814. Akinlusi FM, Rabiu KA, Adewunmi AA, Imosemi OD, Ottun TA, Badmus SA. Complicated unsafe abortion in a Nigerian teaching hospital: pattern of morbidity and mortality. 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Rocca CH, Puri M, Shrestha P, Blum M, Maharjan D, Grossman D, et al. Effectiveness and safety of early medication abortion provided in pharmacies by auxiliary nurse-midwives: A non-inferiority study in Nepal. PLoS ONE. 2018;13(1):e0191174. Kapp N, Bawah AA, Agula C, Menzel JL, Antobam SK, Asuming PO, et al. Medical abortion in Ghana: A non-randomized, non-inferiority study of access through pharmacies compared with clinics. Contraception. 2024;140:110538. Kapp N, Mao B, Menzel J, Eckersberger E, Saphonn V, Rathavy T, et al. A prospective,comparative study of clinical outcomes following clinic-based versus self-use of medical abortion. BMJ Sexual & Reproductive Health. 2023;49(4):300. Moseson H, Jayaweera R, Egwuatu I, Grosso B, Kristianingrum IA, Nmezi S, et al. Effectiveness of self-managed medication abortion with accompaniment support in Argentina and Nigeria (SAFE): a prospective, observational cohort study and non-inferiority analysis with historical controls. Lancet Global Health. 2022;10(1):e105–13. Pedroza C, Truong VT. Performance of models for estimating absolute risk difference in multicenter trials with binary outcome. BMC Med Res Methodol. 2016;16(1):113. StataCorp. Stata Statistical Software: Release 16 College Station., TX: StataCorp LLC; 2019. Hunter C, Burck M, Chambers C, Shawon F, Lavergne MR, Whitten A, et al. Test or No-Test: Comparison of Medication Abortion Outcomes and Adverse Events When Forgoing Ultrasound, Laboratory Testing, and Physical Examination. J Obstet Gynecol Can. 2025;47(1):102730. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 26 Mar, 2026 Read the published version in Reproductive Health → Version 1 posted You are reading this latest preprint version 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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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7652351","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":519487602,"identity":"51cf257f-7fe1-4cad-bb6c-e044697337ff","order_by":0,"name":"Kristen M. 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Ipas","correspondingAuthor":false,"prefix":"","firstName":"Risa","middleName":"","lastName":"Griffin","suffix":""},{"id":519487604,"identity":"6c01b962-231d-40ac-bd6d-3ceac85855d3","order_by":2,"name":"Simone Storey","email":"","orcid":"","institution":"University of Cape Town","correspondingAuthor":false,"prefix":"","firstName":"Simone","middleName":"","lastName":"Storey","suffix":""},{"id":519487605,"identity":"f64c367f-0189-448b-ac62-3754fa9cbe62","order_by":3,"name":"Nkiruka Okwesa","email":"","orcid":"","institution":"Contributions while employed at Ipas","correspondingAuthor":false,"prefix":"","firstName":"Nkiruka","middleName":"","lastName":"Okwesa","suffix":""},{"id":519487606,"identity":"0df5b6c5-bcb9-4cbb-bb1f-0db90944c8b4","order_by":4,"name":"Ayodeji Oginni","email":"","orcid":"","institution":"Contributions while employed at Ipas","correspondingAuthor":false,"prefix":"","firstName":"Ayodeji","middleName":"","lastName":"Oginni","suffix":""},{"id":519487607,"identity":"30c2ace0-3a7c-45d8-ad99-0401322fed73","order_by":5,"name":"Babatunde Adelekan","email":"","orcid":"","institution":"Contributions while employed at Ipas","correspondingAuthor":false,"prefix":"","firstName":"Babatunde","middleName":"","lastName":"Adelekan","suffix":""}],"badges":[],"createdAt":"2025-09-18 18:53:21","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7652351/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7652351/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12978-026-02305-0","type":"published","date":"2026-03-26T16:09:20+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":92872347,"identity":"e3f18063-ef87-4c2a-959f-6a7925d416e5","added_by":"auto","created_at":"2025-10-06 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14:24:40","extension":"xml","order_by":5,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":124520,"visible":true,"origin":"","legend":"","description":"","filename":"7fc8a787e61a4234b2a7d6c928306d3e1structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-7652351/v1/fc55dd3ecce80565de31e92c.xml"},{"id":92872353,"identity":"34f1581a-2870-49ec-98b4-ce70de3c0925","added_by":"auto","created_at":"2025-10-06 14:16:40","extension":"html","order_by":6,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":135768,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7652351/v1/ca4f1fd2c82c8e08f93ba22f.html"},{"id":92872346,"identity":"9115573f-cbf1-4128-9ca1-e862dc5d98be","added_by":"auto","created_at":"2025-10-06 14:16:40","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":39738,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFlow of participants through the study\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-7652351/v1/00ebaa3408be5d851eab0267.png"},{"id":105756106,"identity":"187ace36-f93f-40a7-844f-762880d82d5b","added_by":"auto","created_at":"2026-03-30 16:35:49","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":661322,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7652351/v1/c305dfaa-a315-4141-b73a-0583e5ba07df.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Self-managed medical abortion in Nigeria: A prospective, comparative study of clinical outcomes for a misoprostol-alone regimen obtained from patent medicine vendors compared to clinics","fulltext":[{"header":"PLAIN ENGLISH SUMMARY ","content":"\u003cp\u003eUnsafe abortion remains a major public health issue in Nigeria. Restrictive abortion laws and limited access to contraception mean that many abortions happen outside the formal healthcare system, often under unsafe conditions. This study examined whether women’s clinical outcomes differed when they obtained abortion pills from a clinic compared to a patient medicine vendor (PMV). PMVs are drug sellers who lack formal pharmaceutical training but are allowed to sell certain medicines. We followed 1,572 women across three states in Nigeria who received abortion pills from either a clinic or a PMV. We found that self-managed abortion with pills received from PMVs can be as safe, effective, and acceptable as clinic-based provision for pregnancies under nine weeks. This finding supports global evidence that medication abortion can be managed successfully outside of clinical settings, even in restrictive contexts like Nigeria, where abortion services and post-abortion care are limited. Many women rely on PMVs to access abortion medication, and this study highlights the role they can play in expanding access to safe abortion in Nigeria.\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e"},{"header":"BACKGROUND","content":"\u003cp\u003eUnsafe abortion is a major public health issue in Nigeria, where the high unmet need for contraception and restrictive abortion law results in many abortions occurring outside the formal healthcare system and often under unsafe conditions (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Despite the country\u0026rsquo;s stringent legal framework, induced abortion is commonly practiced and a 2018 population-based survey estimated a 1-year abortion incidence of 29.0 per 1000 women aged 15\u0026ndash;49, while the confidante method yielded a higher estimate of 45.8 per 1000 and considered closer to reality (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). The majority of these abortions were classified as \u0026lsquo;most unsafe\u0026rsquo; and were more common among younger, uneducated, rural, and poor women. Unsafe abortion and related complications contribute substantially to maternal morbidity and mortality in Nigeria (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). Furthermore, many women may not seek post-abortion care due to concerns about confidentiality and lack of trust in the availability of services (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). In 2019, only 20% of primary-level facilities in Nigeria were estimated to be adequately equipped and staffed to provide post-abortion care (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eIn this context, self-managed medical abortion (MA) offers a safe, non-surgical option for terminating early pregnancies. The World Health Organization (WHO) recommends two medication regimens: a combination of mifepristone followed by misoprostol, or misoprostol alone (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). While the combined regimen is highly effective, the misoprostol-alone regimen is widely used, especially in low-resource or legally restrictive settings (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). Misoprostol is more accessible because it has several indications beyond MA, such as management of miscarriage or postpartum hemorrhage (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). The use of misoprostol alone is an effective and safe option (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). The WHO also recommends self-management of MA up to 12 weeks\u0026rsquo; gestation by the pregnant person themselves as well as management by various health professionals, including pharmacy workers, pharmacists, and traditional medicine professionals (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eIn Nigeria, misoprostol is increasingly used for abortion outside the formal healthcare system and is associated with fewer complications than other informal methods (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). A 2020 national survey found that 30% of abortion seekers used pharmacies or patent medicine vendors (PMVs) to obtain misoprostol, primarily due to their affordability and proximity compared to clinics or hospitals (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). PMVs are more commonly used than pharmacies, particularly by women with lower purchasing power, while pharmacies are more likely to be accessed by women with higher levels of education (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Among a sample of Nigerian pharmacies and PMVs, 51% offered abortion pills with 68% of those only stocking misoprostol, making the misoprostol-alone regimen more widely accessible (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). While drug sellers in PMVs are viewed as trusted providers of abortion medication and information, they do not always provide the correct regimen and dosing instructions or adequate guidance on potential complications (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Less than a third of sampled facilities in Nigeria provided correct MA instructions and discussed excessive bleeding as a warning sign (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Nevertheless, even with limited knowledge of misoprostol and how the drug works, most women have been found to safely and successfully self-manage their abortion (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). This was also evident during the COVID-19 pandemic, when many women were still able to safely complete their abortion despite increased barriers to care (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eGrowing evidence supports the safety and effectiveness of self-managed abortions across a range of settings. In Nepal, provision of the combined regimen of mifepristone and misoprostol by trained auxiliary nurse-midwives at pharmacies was found to be non-inferior to care at government facilities (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). Similarly, studies in Cambodia and Ghana found that pharmacy provision of the combined regimen with no direct provider interaction was non-inferior to clinic-based services (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). Meanwhile, in Argentina and Nigeria, a combined or misoprostol-alone regimen in conjunction with an accompaniment model (where people self-source medication and receive evidence-based information and support) was also found to be non-inferior to the documented effectiveness of MA measured in clinical settings (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eHowever, there is limited empirical evidence from Nigeria directly comparing clinical outcomes between women who obtain misoprostol from PMVs and those who access clinic-based care. Given the high demand for abortion services and barriers to formal care, it is valuable to understand how and where women access MA and if their clinical outcomes differ across these settings. This study aims to determine whether important clinical outcomes differ among women who access misoprostol from a PMV when compared with those who access it from a clinic.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eStudy design\u003c/h2\u003e\u003cp\u003eWe conducted a prospective, comparative cohort study of women aged 15\u0026ndash;49 receiving a misoprostol-alone regimen for medical abortion from clinics and PMVs in three states in Nigeria. The primary outcome of interest was additional treatment to complete the abortion within 30 days of using misoprostol. Additional treatment was defined as reporting more than three doses of misoprostol and/or having a surgical procedure after taking at least one dose of misoprostol. A dose was defined as 800 micrograms of misoprostol. Secondary outcomes of interest included confidence that the abortion was complete at 30 days, serious abortion-related complications (defined as a hemorrhage requiring a blood transfusion, hospitalization, serious infection, and undiagnosed ectopic pregnancy), and a woman\u0026rsquo;s medical abortion experience. All outcomes were measured based on participant self-report.\u003c/p\u003e\u003cp\u003eThe required sample size calculation was based upon a non-inferiority design and assumed 80% power to detect a 4-percentage point difference in the primary outcome between the two cohorts, an alpha of 0.05, rho of 0.004, and 20% loss to follow-up by 45-days post-abortion. A four-percentage point difference was chosen to align with other similar studies being conducted at the time (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e), and although a rho of 0.001 is acceptable based on prior research, we increased it to 0.004 to be conservative (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). This resulted in a required sample size of 4,032 participants from 40 sites, 2,016 from PMV sites and 2,016 from clinics. The National Health Research Ethics Committee in Nigeria approved the research protocol for this study (NREC/01/010/2007), and the study was retrospectively registered on clinicaltrials.gov (NCT04242212).\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eParticipant recruitment and data collection\u003c/h3\u003e\n\u003cp\u003eFrom May 2019 through April 2020, women were recruited and enrolled in person, by a trained research assistant, at the point of obtaining misoprostol from a clinic or PMV. We partnered with a total of 102 study sites in Anambra, Ogun, and Oyo, 67 PMVs and 35 clinics. To be eligible for participation, women had to have a known last menstrual period (LMP) of less than 9 weeks, have no known contraindications to misoprostol, be able to give informed consent, and have a mobile phone on which they could be safely reached during the follow-up period. Eligible participants were followed up by phone three to seven days after purchase/provision of misoprostol to confirm pill use, and then again at two time points, 10\u0026ndash;29 days, and 30\u0026ndash;45 days after taking the first dose of misoprostol to assess clinical outcomes. In total, four surveys were completed with participants: a baseline recruitment survey (in-person) and three follow-up surveys (done by phone).\u003c/p\u003e\u003cp\u003eDuring the first follow-up survey (at 3\u0026ndash;7 days after purchasing misoprostol), women were asked to report on the number of doses taken, number of pills taken per dose, route of administration, and timing between doses. During the second and third follow-up calls, women were asked whether they had received additional treatment to complete the abortion in the form of more pills or a surgical procedure like manual vacuum aspiration (MVA). If they said yes, additional treatment details were collected. During the second and third follow-up calls, women were also asked, \u0026ldquo;Since taking the medical abortion pills, did you get treatment from a health care professional for any other problems? The participant\u0026rsquo;s response triggered a series of questions intended to capture serious abortion-related complications. During the second and third follow-up surveys, women were also asked, \u0026ldquo;Do you think you are still pregnant?\u0026rdquo;. This served as a proxy measure for abortion completeness. During the third follow-up survey, women were asked a series of questions about their medical abortion experience.\u003c/p\u003e\u003cp\u003e Participants received remuneration in the form of mobile phone credits for each follow-up call, totaling approximately 16 US dollars. All data were collected on secure Android tablets using the Dimagi CommCare cloud-based survey management system.\u003c/p\u003e\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003eStatistical analysis\u003c/h2\u003e\u003cp\u003eDescriptive analyses were conducted for sociodemographic characteristics, MA characteristics, additional treatment to complete the abortion, and MA experience. For categorical variables, frequencies and percentages are presented by study site type (clinic or PMV). Bivariate analysis compared percentages or means by study site type, and reported p-values are adjusted for clustering of responses by study site. For continuous variables, means and standard deviations are presented by study site type and t-tests were used to detect differences.\u003c/p\u003e\u003cp\u003eFor the non-inferiority analysis, we computed crude risk differences in outcomes by group (clinic versus PMV) using bivariate Poisson generalized estimating equations (GEE) models that account for clustering by recruitment site; these models were chosen because they perform well in simulation studies of multi-center trials with binary outcome data (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). The adjusted risk difference was calculated by including in the models the socio-demographic and reproductive characteristics that were significantly different between groups (age, education, occupation, marital status, and parity). We calculated 95% confidence intervals on the crude and adjusted risk differences, and if the confidence interval did not cross the non-inferiority limit of 4%, we considered PMVs non-inferior to clinics in terms of additional treatment to complete the abortion. We assessed differences in abortion experience by group, including preparedness for the medical abortion process and whether the participant would recommend medical abortion to a friend, using multilevel mixed effects models including random effects for sites.\u003c/p\u003e\u003cp\u003eCases with missing primary outcome data were excluded from this analysis. Missing data (i.e., responses of refused or don\u0026rsquo;t know) for other variables were imputed to the mean. Statistical significance was defined as an alpha of 0.05 or less, and all p-values are adjusted for clustering at the site level. All analyses were conducted using Stata version 16 (StataCorp) (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e).\u003c/p\u003e\u003c/div\u003e"},{"header":"RESULTS","content":"\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\u003ch2\u003eEligibility and enrollment\u003c/h2\u003e\u003cp\u003eOver a period of 11 months, 1,843 women (1,004 from clinics and 839 from PMVs) were assessed for eligibility. Of those women, 1,835 (1,000 from clinics and 835 from PMVs) provided baseline information and consented to be followed up by phone. At survey one, we enrolled 1,711 women (928 from clinics and 783 from PMVs) who confirmed taking misoprostol. For the analyses, we included the 1,572 women (824 from clinics and 748 from PMVs) with complete data on the primary outcome. The flow of participants through the study is detailed in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. The lost to follow-up (LTFU) rate among enrolled individuals was 8% (11% from clinics and 4% from PMVs). Although we did not achieve the desired sample size of 2,016 women per cohort, our LTFU was significantly lower than anticipated, thereby resulting in the study still being powered at 80% to detect a 4-percentage point difference in the primary outcome between the two cohorts.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003eSociodemographic and reproductive history characteristics\u003c/h2\u003e\u003cp\u003eSeveral sociodemographic characteristic differences emerged between the two cohorts (Table\u0026nbsp;1). Participants in the clinic cohort were slightly younger, had less formal education, engaged in more manual labor, and were less likely to be married. In terms of reproductive histories, no significant differences existed between the two cohorts for gravidity, previous abortion, or type of previous abortion; women in the clinic cohort were less likely to have previously given birth (Table\u0026nbsp;1).\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eMedical abortion characteristics\u003c/h3\u003e\n\u003cp\u003eMost women were less than eight weeks pregnant at baseline and used either Miso-Fem or Misoclear branded products, with women getting pills at clinics being more likely to be given Misoclear (Table\u0026nbsp;2). Almost ninety-four percent of women took one, two or three doses of misoprostol. Although we found no statistically significant difference between the cohorts, only 25% of women reported taking the misoprostol in alignment with the WHO recommended regimen (defined as 4 pills (200 micrograms each), vaginally, in-cheek or under the tongue), with 3 hours between doses).\u003c/p\u003e\n\u003ch3\u003eAdditional treatment to complete the abortion (primary outcome)\u003c/h3\u003e\n\u003cp\u003eThe rate of additional treatment to complete the abortion was 9.5% (n\u0026thinsp;=\u0026thinsp;78) in the clinic cohort and 3.6% (n\u0026thinsp;=\u0026thinsp;27) in the PMV cohort for a crude risk difference of -5.9%. Adjusting for age, education, occupation, marital status, and parity, the risk difference was \u0026minus;\u0026thinsp;6.2%, indicating non-inferiority of the PMV cohort to the clinic cohort (Table\u0026nbsp;3).\u003c/p\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003eAbortion completeness (secondary outcome)\u003c/h2\u003e\u003cp\u003eAt survey two (10\u0026ndash;29 days post-misoprostol) or survey three (30\u0026ndash;45 days post-misoprostol) 92.8% (n\u0026thinsp;=\u0026thinsp;1398) of women reported confidence that the abortion was complete, 93.1% (n\u0026thinsp;=\u0026thinsp;713) among the clinic cohort and 92.6% (n\u0026thinsp;=\u0026thinsp;685) among the PMV cohort for a crude risk difference of 0.9%. After adjusting for characteristic differences between the clinic and PMV cohorts, the adjusted risk difference (0.6%) was not significantly different between cohorts (Table\u0026nbsp;3).\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003eComplications (secondary outcome)\u003c/h2\u003e\u003cp\u003eAlthough a small proportion of women in each cohort reported visiting a health care professional at some point between day 10 and day 45 post-misoprostol (Table\u0026nbsp;3), the difference was not significant between the cohorts. No study participants reported a hemorrhage requiring a blood transfusion, hospitalization, serious infection, or an undiagnosed (at the time of taking misoprostol) ectopic pregnancy.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\u003ch2\u003eMedical abortion experience (secondary outcome)\u003c/h2\u003e\u003cp\u003eThe medical abortion experiences between the two cohorts were quite similar, with almost 92% (n\u0026thinsp;=\u0026thinsp;1572) of women feeling prepared for what would happen after taking the pills (Table\u0026nbsp;4). A small proportion of women (n\u0026thinsp;=\u0026thinsp;129) reported experiencing a symptom or side effect that was unexpected, including more pain, nausea, and vomiting, but there were no differences between the groups for most variables. Women from the PMV group were significantly more likely to report experiencing heavier bleeding than expected (p\u0026thinsp;=\u0026thinsp;0.028).\u003c/p\u003e\u003cp\u003eThe acceptability of a woman\u0026rsquo;s MA experience was measured by whether the participant would recommend medical abortion to a friend. The response was similar between the groups, with 89% (n\u0026thinsp;=\u0026thinsp;736) of the clinic cohort and 90% (n\u0026thinsp;=\u0026thinsp;670) of the PMV cohort reporting that they would recommend MA to a friend (Table\u0026nbsp;4). A very small minority of women (1%) stated that they would not recommend any type of abortion to a friend.\u003c/p\u003e\u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eParticipants who obtained misoprostol for MA directly from PMVs in Nigeria without prior consultation with a trained provider experienced comparable clinical outcomes in terms of safety, effectiveness, and acceptability as those who accessed misoprostol through clinic-based care for pregnancies under nine weeks\u0026rsquo; gestation. These findings build on the body of evidence showing that MA can be managed successfully outside of clinical settings, even in contexts where abortion-related mortality is high and additional support is limited (\u003cspan additionalcitationids=\"CR18 CR19\" citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eAs in similar studies in Cambodia and Ghana, overall additional treatment rates to complete the abortion were low between those who obtained misoprostol from PMVs or accessed clinic-based care (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). While not a significant difference, all of these studies observed that additional treatment to complete the abortion was more common in the clinic group than the PMV or pharmacy group. This may be explained by participants in the clinic group having more familiarity with the clinical setting and finding it easier to access clinic-based care, whereas participants in the PMV group may have faced similar challenges to seeking additional treatment as initially seeking misoprostol from a clinical setting (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). Similar to participants in Cambodia, demographic differences were seen between the PMV and clinic groups (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). Participants in the clinic group tended to be younger, less educated, unmarried, and less likely to have previously given birth, which may also explain why they were more likely to seek additional treatment than participants in the PMV group which may have been more experienced. A small proportion visited a healthcare professional for other treatment with no statistically significant difference between groups, consistent with findings in Cambodia, Ghana, and Nepal (\u003cspan additionalcitationids=\"CR18\" citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eHowever, there were also some differences between the current study and those previously conducted in Cambodia and Ghana. We found a much higher confidence that the abortion was complete in both the clinic and PMV groups compared to those in Cambodia and Ghana, which was more aligned with the high confidence observed in similar studies in Nepal, Argentina, and Nigeria (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). Participants in both groups reported no complications or ectopic pregnancies, contrasting with a few complications and one ectopic pregnancy in both pharmacy groups reported in Cambodia and Ghana (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). The current study also found higher acceptability than those in Cambodia and Ghana with most participants in both groups willing to recommend MA to a friend and only 1% overall would not recommend abortion at all (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eInterestingly, we observed a much lower adherence with only 25% of all participants following the WHO recommended MA dosing regimen, compared to almost all participants in Cambodia and 87% of participants in Ghana taking the medication correctly (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). Furthermore, heavier bleeding than expected was experienced by 40% of participants in the PMV group, significantly more than those who access clinic-based care. Given the known lack of accurate and complete instructions provided by drug sellers, this may explain why so many participants did not follow the correct regimen and did not expect heavy bleeding (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Nevertheless, the majority of participants reported feeling prepared for what would happen after taking the misoprostol and were able to safely and successfully self-manage their abortion, echoing previous findings in Nigeria (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eAn important limitation to this study is that data for all outcomes were self-reported and unconfirmed by medical records or providers\u0026rsquo; diagnoses. To address this, we chose an objective primary outcome of additional treatment to complete the abortion. While we relied on self-reported gestational age and confidence that the abortion was complete, evidence supports that reporting last menstrual period and self-assessing the success of the abortion are comparable to ultrasound assessment (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). A further limitation may be the generalizability of these findings in settings with more barriers to clinical support for additional treatment or to women purchasing misoprostol above nine weeks\u0026rsquo; gestation.\u003c/p\u003e\u003cp\u003eA key strength of this study is demonstrating the effectiveness of self-managed MA using the misoprostol-alone regimen. While similar studies have shown the combination regimen with quality-assured commodities or the misoprostol-alone regimen with accompaniment support, our results show that misoprostol alone, sourced from a range of brands and taken without direct provider oversight, was effective and comparable to clinic-based provision. This is a valuable contribution to the literature on self-managed abortion, particularly in restrictive settings, and aligns with WHO guidance (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Additionally, our low LTFU supported internal validity and maintained the study\u0026rsquo;s power, despite a lower sample size than initially targeted.\u003c/p\u003e\u003cp\u003eWhile the current study demonstrates self-managed MA with misoprostol-alone regimens obtained from PMVs to be safe and effective with similar clinical outcomes to clinic-provision, it also highlights the opportunity to improve the quality of information provision by drug sellers to adequately prepare women on how to take the medication, what to expect, and when to potentially seek additional treatment. We support existing recommendations to develop the technical competency of drug sellers to better support women self-managing their abortions (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Aligned with previous findings, the capacity to provide post-abortion care should also be developed in primary-level facilities (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Future research should further examine the use of misoprostol-alone regimens in other restrictive settings and explore strategies to improve access, support, and accurate use.\u003c/p\u003e"},{"header":"CONCLUSIONS","content":"\u003cp\u003eThis study shows that self-managed abortion with misoprostol alone obtained from PMVs can be as safe, effective, and acceptable as clinic-based provision for pregnancies under nine weeks\u0026rsquo; gestation in Nigeria. Self-management offers a valuable pathway to expanding access to safe abortion, especially in restrictive settings, but improving drug sellers\u0026rsquo; competency to provide accurate information is essential to maximize safety and effectiveness.\u003c/p\u003e"},{"header":"ABBREVIATIONS","content":"\u003cp\u003eGEE Generalized estimating equations\u003c/p\u003e\u003cp\u003eLMP Last menstrual period\u003c/p\u003e\u003cp\u003eLTFU Loss to follow up\u003c/p\u003e\u003cp\u003eMVA Manual vacuum aspiration\u003c/p\u003e\u003cp\u003eMA Medical abortion\u003c/p\u003e\u003cp\u003ePMV Patent medicine vendor\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eThe ethical approval board (NHREC) granted the research a waiver of parental consent given that young women are often excluded from studies about abortion outcomes.\u003c/p\u003e\n\u003cp\u003eA revised statement could say\" \"All research participants were guided through an informed consent process and provided written informed consent by digitally signing their name on the tablet being used for data collection. The ethical review board granted this research a waiver of parental consent for women age 15-17 given that young women are often excluded from studies about abortion outcomes. Participants were provided with a paper copy of the informed consent if desired.\"\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eThe National Health Research Ethics Committee in Nigeria approved the research protocol for this study (NREC/01/010/2007). Informed consent was provided by all study participants, and all research was conducted in accordance with the Declaration of Helsinki.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eNot applicable.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003ch2\u003eCompeting interests\u003c/h2\u003e\u003cp\u003eWe declare no competing interests.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003ch2\u003eFunding\u003c/h2\u003e\u003cp\u003eThis research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The study was funded internally at Ipas, and Ipas had a direct role in the study design, data collection, data analysis, data interpretation, and writing of the manuscript.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eKMS conceptualized and led the study. BA and AO provided study oversight. NO was responsible for study administration and supervision. RG managed the data and conducted the analysis. KMS, RG, and SS lead the manuscript writing. All authors critically reviewed and edited the manuscript.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eWe thank Natalie Kapp for serving as a technical advisor on this study. We thank Erin Pearson for reviewing our data and providing feedback on the analysis. We thank Lucky Palmer for his support with this study. Also, we would like to thank all the women who shared their abortion experience information with us, and all the clinicians, patent medicine vendors, and research assistants who supported the data collection efforts.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe datasets generated and/or analyzed during the current study are not publicly available due the sensitive nature of abortion provision in Nigeria, but can be made available from the corresponding author on reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eAkande OW, Adenuga AT, Ejidike IC, Olufosoye AA. Unsafe abortion practices and the law in Nigeria: time for change. Sex Reproductive Health Matters. 2020;28(1):1758445.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSuzanne OB, Elizabeth O, Funmilola O, Mridula S, Caroline M. Inequities in the incidence and safety of abortion in Nigeria. BMJ Global Health. 2020;5(1):e001814.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAkinlusi FM, Rabiu KA, Adewunmi AA, Imosemi OD, Ottun TA, Badmus SA. Complicated unsafe abortion in a Nigerian teaching hospital: pattern of morbidity and mortality. J Obstet Gynaecol. 2018;38(7):961\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eOni TO, Adebowale SA, Afolabi AA, Akinyemi AI, Banjo OO. Perceived health facility-related barriers and post-abortion care-seeking intention among women of reproductive age in Osun state, Nigeria. BMC Womens Health. 2023;23(1):311.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMuga W, Juma K, Athero S, Kimemia G, Bangha M, Ouedraogo R. Barriers to post-abortion care service provision: A cross-sectional analysis in Burkina Faso, Kenya and Nigeria. PLOS Global Public Health. 2024;4(3):e0001862.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWorld Health Organization. Abortion care guideline. World Health Organization; 2022.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eJayaweera RT, Moseson H, Gerdts C. Misoprostol in the era of COVID-19: a love letter to the original medical abortion pill. Sex Reproductive Health Matters. 2020;28(1):1829406.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGrossman A, Prata N, Williams N, Ganatra B, Lavelanet A, L\u0026auml;ser L, et al. Availability of medical abortion medicines in eight countries: a descriptive analysis of key findings and opportunities. Reprod Health. 2023;20(Suppl 1):58.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRaymond EG, Weaver MA, Shochet T. Effectiveness and safety of misoprostol-only for first-trimester medication abortion: An updated systematic review and meta-analysis. Contraception. 2023;127:110132.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBello FA, Fawole B, Oluborode B, Awowole I, Irinyenikan T, Awonuga D, et al. Trends in misoprostol use and abortion complications: A cross-sectional study from nine referral hospitals in Nigeria. PLoS ONE. 2019;13(12):e0209415.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eByrne ME, Omoluabi E, OlaOlorun FM, Moreau C, Bell SO. Determinants of women\u0026rsquo;s preferred and actual abortion provision locations in Nigeria. Reproductive Health. 2021;18(1):240.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAkinyemi A, Owolabi OO, Erinfolami T, Stillman M, Bankole A. Quality of information offered to women by drug sellers providing medical abortion in Nigeria: Evidence from providers and their clients. Front Global Women's Health. 2022;Volume 3\u0026ndash;2022.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eShankar M, Omoluabi E, OlaOlorun FM, Khanna A, Ahmad D, Moreau C, et al. Quality of care offered by health care retail markets for medication abortion self-management: Findings from states in Nigeria and India. PLOS Global Public Health. 2025;5(1):e0003971.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eStillman M, Owolabi O, Fatusi AO, Akinyemi AI, Berry AL, Erinfolami TP, 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;10(5):e034670.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eV\u0026auml;is\u0026auml;nen H, Moore AM, Owolabi O, Stillman M, Fatusi A, Akinyemi A. Sexual and reproductive health literacy, misoprostol knowledge and use of medication abortion in Lagos State, Nigeria: a mixed methods study. Stud Fam Plann. 2021;52(2):217\u0026ndash;37.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eEgwuatu I, Nmezi S, Jayaweera R, Motana R, Grosso B, Kristianingrum IA, et al. Effectiveness of self-managed abortion during the COVID-19 pandemic: Results from a pooled analysis of two prospective, observational cohort studies in Nigeria. PLOS Global Public Health. 2022;2(10):e0001139.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRocca CH, Puri M, Shrestha P, Blum M, Maharjan D, Grossman D, et al. Effectiveness and safety of early medication abortion provided in pharmacies by auxiliary nurse-midwives: A non-inferiority study in Nepal. PLoS ONE. 2018;13(1):e0191174.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKapp N, Bawah AA, Agula C, Menzel JL, Antobam SK, Asuming PO, et al. Medical abortion in Ghana: A non-randomized, non-inferiority study of access through pharmacies compared with clinics. Contraception. 2024;140:110538.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKapp N, Mao B, Menzel J, Eckersberger E, Saphonn V, Rathavy T, et al. A prospective,comparative study of clinical outcomes following clinic-based versus self-use of medical abortion. BMJ Sexual \u0026amp; Reproductive Health. 2023;49(4):300.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMoseson H, Jayaweera R, Egwuatu I, Grosso B, Kristianingrum IA, Nmezi S, et al. Effectiveness of self-managed medication abortion with accompaniment support in Argentina and Nigeria (SAFE): a prospective, observational cohort study and non-inferiority analysis with historical controls. Lancet Global Health. 2022;10(1):e105\u0026ndash;13.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePedroza C, Truong VT. Performance of models for estimating absolute risk difference in multicenter trials with binary outcome. BMC Med Res Methodol. 2016;16(1):113.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eStataCorp. Stata Statistical Software: Release 16 College Station., TX: StataCorp LLC; 2019.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHunter C, Burck M, Chambers C, Shawon F, Lavergne MR, Whitten A, et al. Test or No-Test: Comparison of Medication Abortion Outcomes and Adverse Events When Forgoing Ultrasound, Laboratory Testing, and Physical Examination. J Obstet Gynecol Can. 2025;47(1):102730.\u003c/span\u003e\u003c/li\u003e\u003c/ol\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":"Nigeria, abortion, misoprostol, abortion pills, misoprostol alone, medical abortion, medication abortion, patent medicine vendors, pharmacy, clinics","lastPublishedDoi":"10.21203/rs.3.rs-7652351/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7652351/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground\u003c/p\u003e\n\u003cp\u003eTo determine whether important clinical outcomes differ among women who access misoprostol alone from a PMV when compared with those who access it from a clinic.\u003c/p\u003e\n\u003cp\u003eMethods\u003c/p\u003e\n\u003cp\u003eWe conducted a prospective, comparative cohort study of women aged 15-49 accessing a misoprostol-alone regimen from clinics and PMVs in three states of Nigeria. Women were recruited at the point of accessing misoprostol at a clinic or PMV. Follow-up by telephone to confirm pill use and access clinical outcomes at three to seven days, 10-29 days, and 30-45 days after taking misoprostol.\u003c/p\u003e\n\u003cp\u003eResults\u003c/p\u003e\n\u003cp\u003eOver 11 months, we enrolled 1835 women, and complete data was available from 1572 women (824 from clinics and 748 from PMVs). The rate of additional treatment to complete the abortion was non-inferior for the pharmacy group (3.6%) compared with the clinic cohort (9.5%). Although a small proportion of women in each cohort reported visiting a health care professional after taking misoprostol, no complications were reported. Most women felt prepared for what would happen after the misoprostol (92% of both cohorts) and would recommend medical abortion to a friend (89% of the clinic cohort and 90% of the PMV cohort).\u003c/p\u003e\n\u003cp\u003eConclusions\u003c/p\u003e\n\u003cp\u003eSelf-managed abortion with misoprostol alone from PMVs was comparable in safety, effectiveness, and acceptability to clinic-based care, in line with global evidence supporting self-management of abortion care.\u003c/p\u003e\n\u003cp\u003eTrial Registration\u003c/p\u003e\n\u003cp\u003eRetrospectively registered at ClinicalTrials.gov ID NCT04242212\u003c/p\u003e","manuscriptTitle":"Self-managed medical abortion in Nigeria: A prospective, comparative study of clinical outcomes for a misoprostol-alone regimen obtained from patent medicine vendors compared to clinics","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-06 14:16:35","doi":"10.21203/rs.3.rs-7652351/v1","editorialEvents":[{"type":"communityComments","content":0}],"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":"5cd60046-ea76-44dc-a570-62ddd45f60c2","owner":[],"postedDate":"October 6th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-03-30T16:34:47+00:00","versionOfRecord":{"articleIdentity":"rs-7652351","link":"https://doi.org/10.1186/s12978-026-02305-0","journal":{"identity":"reproductive-health","isVorOnly":false,"title":"Reproductive Health"},"publishedOn":"2026-03-26 16:09:20","publishedOnDateReadable":"March 26th, 2026"},"versionCreatedAt":"2025-10-06 14:16:35","video":"","vorDoi":"10.1186/s12978-026-02305-0","vorDoiUrl":"https://doi.org/10.1186/s12978-026-02305-0","workflowStages":[]},"version":"v1","identity":"rs-7652351","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7652351","identity":"rs-7652351","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}