RT Journal Article
SR Electronic
T1 Studying Accompaniment model Feasibility and Effectiveness (SAFE) Study: study protocol for a prospective observational cohort study of the effectiveness of self-managed medication abortion
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e036800
DO 10.1136/bmjopen-2020-036800
VO 10
IS 11
A1 Heidi Moseson
A1 Brianna Keefe-Oates
A1 Ruvani T Jayaweera
A1 Sofia Filippa
A1 Relebohile Motana
A1 Chiara Bercu
A1 Ijeoma Egwuatu
A1 Belen Grosso
A1 Ika Ayu Kristianingrum
A1 Sybil Nmezi
A1 Ruth Zurbriggen
A1 Emmeline Friedman
A1 Caitlin Gerdts
YR 2020
UL http://bmjopen.bmj.com/content/10/11/e036800.abstract
AB 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.