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Observational Study
. 2020 Nov 19;10(11):e036800.
doi: 10.1136/bmjopen-2020-036800.

Studying Accompaniment model Feasibility and Effectiveness (SAFE) Study: study protocol for a prospective observational cohort study of the effectiveness of self-managed medication abortion

Heidi Moseson  1 , Brianna Keefe-Oates  2 , Ruvani T Jayaweera  3 , Sofia Filippa  4 , Relebohile Motana  5 , Chiara Bercu  3 , Ijeoma Egwuatu  6 , Belen Grosso  7 , Ika Ayu Kristianingrum  8 , Sybil Nmezi  6 , Ruth Zurbriggen  7 , Emmeline Friedman  9 , Caitlin Gerdts  3
Affiliations
Observational Study

Studying Accompaniment model Feasibility and Effectiveness (SAFE) Study: study protocol for a prospective observational cohort study of the effectiveness of self-managed medication abortion

Heidi Moseson et al. BMJ Open. .

Abstract

Introduction: A range of barriers deter or prevent people from accessing facility-based abortion care. As a result, people are obtaining and using abortifacient medications to end their pregnancies outside of the formal healthcare system, without clinical supervision. One model of self-managed abortion has come to be known as the 'accompaniment' model, in which grassroots organisations provide pregnant people with evidence-based counselling and support through the medication abortion process. Data are needed to understand the safety and effectiveness of this increasingly common model of abortion care.

Methods and analysis: This is a large, prospective, observational study in Argentina and Nigeria. All people who contact one of two accompaniment groups seeking information for their own self-managed medication abortion, are ages 13 years and older, have no contraindications for medication abortion, are within the gestational range supported by the group (up to 12 weeks' gestation for the primary outcome) and are willing to be contacted for follow-up will be recruited. Participants will respond to an interviewer-administered baseline survey at enrolment, and 1-4 additional surveys over 6 weeks to ascertain whether they obtain medications for abortion, dosing and route of administration of medications, physical and emotional experience of medication abortion self-management, and effectiveness and safety outcomes. Analyses will include estimates of the primary outcome: the proportion of participants that report a complete abortion without surgical intervention at last recorded follow-up; as well as secondary outcomes including a pseudo-experimental test of non-inferiority of the effectiveness of self-managed medication abortion as compared with clinical medication abortion.

Ethics and dissemination: We describe the ethical considerations and protections for this study, as well the creation of a study-specific Data Monitoring and Oversight Committee. We describe dissemination plans to ensure that study results are shared widely with all relevant audiences, particularly researchers, advocates, policymakers and clinicians.

Trial registration number: ISRCTN95769543.

Keywords: abortion; accompaniment; medication abortion; mifepristone; misoprostol; self-managed abortion.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
SAFE Study procedures. N/A, not available; SAFE Study, Studying Accompaniment model Feasibility and Effectiveness Study.
See this image and copyright information in PMC

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References

    1. Baum S, DePiñeres T, Grossman D. Delays and barriers to care in Colombia among women obtaining legal first- and second-trimester abortion. Int J Gynaecol Obstet 2015;131:285–8. 10.1016/j.ijgo.2015.06.036 - DOI - PubMed
    1. Finer LB, Frohwirth LF, Dauphinee LA, et al. . Timing of steps and reasons for delays in obtaining abortions in the United States. Contraception 2006;74:334–44. 10.1016/j.contraception.2006.04.010 - DOI - PubMed
    1. Gerdts C, Fuentes L, Grossman D, et al. . Impact of clinic closures on women obtaining abortion services after implementation of a restrictive law in Texas. Am J Public Health 2016;106:857–64. 10.2105/AJPH.2016.303134 - DOI - PMC - PubMed
    1. Kiley JW, Yee LM, Niemi CM, et al. . Delays in request for pregnancy termination: comparison of patients in the first and second trimesters. Contraception 2010;81:446–51. 10.1016/j.contraception.2009.12.021 - DOI - PubMed
    1. Aiken ARA, Digol I, Trussell J, et al. . 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. 10.1136/bmj.j2011 - DOI - PMC - PubMed

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