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

Moseson, Heidi; Jayaweera, Ruvani; Egwuatu, Ijeoma; Grosso, Belén; Kristianingrum, Ika Ayu; Nmezi, Sybil; Zurbriggen, Ruth; Motana, Relebohile; Bercu, Chiara; Carbone, Sofía; Gerdts, Caitlin

doi:10.1016/s2214-109x(21)00461-7

Cited by 77 publications

(100 citation statements)

References 34 publications

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“…While additional research on self-managed abortion in general is needed, previous studies demonstrate that self-managed medication abortion up to 12 weeks’ gestation using mifepristone and misoprostol has an efficacy rate ranging from 78.7% to 99.5%, and from 75% to 99% using a misoprostol only regimen ( Moseson et al, 2020 , 2021 ). These efficacy results are similar to clinical outcomes of the standard FDA-approved protocol of mifepristone and misoprostol, found to be 95% effective up to 10 weeks’ gestation ( Chen & Creinin, 2015 ; Gatter et al, 2015 ).…”

Section: Introductionmentioning

confidence: 99%

U.S. Abortion Care Providers’ Perspectives on Self-Managed Abortion

et al. 2022

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State-level restrictions on abortion access may prompt greater numbers of people to self-manage their abortion. The few studies exploring perspectives of providers towards self-managed abortion are focused on physicians and advanced practice clinicians. Little is known about the wider spectrum of abortion care providers who encounter self-managed abortion in their clinic-based work. To gain a deeper understanding of this issue and inform future care delivery, we conducted in-depth interviews with 46 individuals working in a range of positions in 46 abortion clinics across 29 states. Our interpretative analysis resulted in themes shaped by beliefs about safety and autonomy, and a tension between the two: that self-managed abortion is too great a risk, that people are capable of self-managing an abortion, and that people have a right to a self-managed abortion. Our findings highlight the importance of increasing knowledge and clarifying values among all abortion care providers, including clinic staff.

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Section: Introductionmentioning

confidence: 99%

U.S. Abortion Care Providers’ Perspectives on Self-Managed Abortion

et al. 2022

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“…Known as safe abortion hotlines or feminist abortion accompaniment networks, these groups provide evidence-based information 3 to pregnant people on how to safely use medications to end a pregnancy. 5 These groups aim to provide information and support in a way that empowers, validates, and affirms each person while also educating them about their body – transforming the traditional patriarchal hierarchy of the clinician–patient relationship to an egalitarian, feminist model of peer-to-peer education. 4 As well as providing accompaniment support to people through the abortion process, many accompaniment groups lobby governments and lawmakers to liberalise abortion laws, and build relationships with local clinicians to expand safe abortion options.…”

Section: A New Collaboration: Backgroundmentioning

confidence: 99%

“…Recognising that self-managed medical abortion with accompaniment support is an increasingly visible and salient model of abortion care 5 with great promise to expand access to high-quality abortion regardless of legal setting, we have explored partnerships between researchers and accompaniment groups to document this model and raise awareness. Over the past decade, we have built collaborative, activist–researcher partnerships to describe safe abortion hotlines and the accompaniment model of care in the peer-reviewed literature – work that has outlined the model, evaluated innovative approaches to providing people with support, explored experiences of self-managed abortion in later pregnancy – and has, to date, built a foundation of evidence on the importance of the accompaniment model in centring the experiences of people in need of abortion care.…”

Section: A New Collaboration: Formationmentioning

confidence: 99%

“…In 2018, we came together as a research organisation and three activist accompaniment groups to co-design a study to definitively evaluate self-managed abortion with accompaniment support: the Studying Accompaniment Feasibility and Effectiveness (SAFE) study. 5 The aim of this study would be to systematically evaluate the effectiveness of self-managed medical abortion in a larger, prospective, multi-national context.…”

Section: A New Collaboration: Formationmentioning

confidence: 99%

“… 1 However, prospective data on self-managed abortion were harder to come by, no statistical comparison to the effectiveness of clinician-managed abortion had been conducted, and safety and effectiveness outcomes of self-managed abortion supported by the accompaniment model had not been widely documented. 5 Indeed, a research agenda developed by a multi-disciplinary team of researchers identified the rigorous evaluation of the effectiveness of self-managed medical abortion as one of three priority research gaps, 13 specifically identifying participant recruitment and participant follow-up over time as key challenges that research on self-managed abortion needed to address.…”

Section: A New Collaboration: Formationmentioning

confidence: 99%

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Overcoming challenges in research on self-managed medical abortion: lessons from a collaborative activist–researcher partnership

Kristianingrum¹,

Nmezi²,

Zurbriggen³

et al. 2022

Sexual and Reproductive Health Matters

Self Cite

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Comparison of No-Test Telehealth and In-Person Medication Abortion

Ralph,

Baba,

Biggs

et al. 2024

JAMA

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ImportanceIn the US, access to medication abortion using history-based (no-test) eligibility assessment, including through telehealth and mailing of mifepristone, has grown rapidly. Additional evidence on the effectiveness and safety of these models is needed.ObjectiveTo evaluate whether medication abortion with no-test eligibility assessment and mailing of medications is as effective as in-person care with ultrasonography and safe overall.Design, Setting, and ParticipantsProspective, observational study with noninferiority analysis. Sites included 4 abortion-providing organizations in Colorado, Illinois, Maryland, Minnesota, Virginia, and Washington from May 2021 to March 2023. Eligible patients were seeking medication abortion up to and including 70 days’ gestation, spoke English or Spanish, and were aged 15 years or older.ExposureStudy groups reflected the model of care selected by the patient and clinicians and included: (1) no-test (telehealth) eligibility assessment and mailing of medications (no-test + mail) (n = 228); (2) no-test eligibility assessment and pickup of medications (no-test + pickup) (n = 119); or (3) in-person with ultrasonography (n = 238).Main Outcomes and MeasuresEffectiveness, defined as a complete abortion without the need for repeating the mifepristone and misoprostol regimen or a follow-up procedure, and safety, defined as an abortion-related serious adverse event, including overnight hospital admission, surgery, or blood transfusion. Outcomes were derived from patient surveys and medical records. Primary analysis focused on the comparison of the no-test + mail group with the in-person with ultrasonography group.ResultsThe mean age of the participants (N = 585) was 27.3 years; most identified as non-Hispanic White (48.6%) or non-Hispanic Black (28.1%). Median (IQR) gestational duration was 45 days (39-53) and comparable between study groups (P = .30). Outcome data were available for 91.8% of participants. Overall effectiveness was 94.4% (95% CI, 90.7%-99.2%) in the no-test + mail group and 93.3% (95% CI, 88.3%-98.2%) in the in-person with ultrasonography group in adjusted models (adjusted risk difference, 1.2 [95% CI, −4.1 to 6.4]), meeting the prespecified 5% noninferiority margin. Serious adverse events included overnight hospitalization (n = 4), blood transfusion (n = 2), and emergency surgery (n = 1) and were reported by 1.1% (95% CI, 0.4%-2.4%) of participants, with 3 in the no-test + mail group, 3 in the in-person with ultrasonography group, and none in the no-test + pickup group.Conclusions and RelevanceThis prospective, observational study found that medication abortion obtained following no-test telehealth screening and mailing of medications was associated with similar rates of complete abortion compared with in-person care with ultrasonography and met prespecified criteria for noninferiority, with a low prevalence of adverse events.

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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

Cited by 77 publications

References 34 publications

U.S. Abortion Care Providers’ Perspectives on Self-Managed Abortion

U.S. Abortion Care Providers’ Perspectives on Self-Managed Abortion

Overcoming challenges in research on self-managed medical abortion: lessons from a collaborative activist–researcher partnership

Comparison of No-Test Telehealth and In-Person Medication Abortion

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