Evidence map›Paper›PMID 34801131›Full record

ArticleThe Lancet. Global health2022

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.

Heidi Moseson, Ruvani Jayaweera, Ijeoma Egwuatu, Belén Grosso, Ika Ayu Kristianingrum, Sybil Nmezi, Ruth Zurbriggen, Relebohile Motana, Chiara Bercu, Sofía Carbone and 1 more

Open access · goldAbstract read
In one paragraph

Article in The Lancet. Global health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed
15.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 109 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 2 countries.

Heidi MosesonIbis Reproductive Health, Oakland, CA, USA. Electronic address: hmoseson@ibisreproductivehealth.org.
Ruvani JayaweeraIbis Reproductive Health, Oakland, CA, USA.
Ijeoma EgwuatuGeneration Initiative for Women and Youth, Lagos, Nigeria.
Belén GrossoLa Revuelta Colectiva Feminista, Neuquén, Argentina.
Ika Ayu KristianingrumSamsara, Yogyakarta, Indonesia.
Sybil NmeziGeneration Initiative for Women and Youth, Lagos, Nigeria.
Ruth ZurbriggenLa Revuelta Colectiva Feminista, Neuquén, Argentina.
Relebohile MotanaIbis Reproductive Health, Johannesburg, South Africa.
Chiara BercuIbis Reproductive Health, Oakland, CA, USA.
Sofía CarboneIbis Reproductive Health, Oakland, CA, USA.
Caitlin GerdtsIbis Reproductive Health, Oakland, CA, USA.
Ibis Reproductive Health · USIbis Reproductive Health · ZA

Funding

Toward an improved screening protocol: developing and testing an organ inventory for strengthening clinical care and researchR21CA256759 · NCI · IBIS REPRODUCTIVE HEALTH · PI MOSESON LIDOW, HEIDI SERENE · 2020 to 2021
$317k
NCI NIH HHS R21 CA256759
6 · The paper itself

Abstract

backgroundClinical trials have established the high effectiveness and safety of medication abortion in clinical settings. However, barriers to clinical abortion care have shifted most medication abortion use to out-of-clinic settings, especially in the context of the COVID-19 pandemic. Given this shift, we aimed to estimate the effectiveness of self-managed medication abortion (medication abortion without clinical support), and to compare it to effectiveness of clinician-managed medication abortion.

methodsFor this prospective, observational cohort study, we recruited callers from two safe abortion accompaniment groups in Argentina and Nigeria who requested information on self-managed medication abortion. Before using one of two medication regimens (misoprostol alone or in combination with mifepristone), participants completed a baseline survey, and then two follow-up phone surveys at 1 week and 3 weeks after taking pills. The primary outcome was the proportion of participants reporting a complete abortion without surgical intervention. Legal restrictions precluded enrolment of a concurrent clinical control group; thus, a non-inferiority analysis compared abortion completion among those in our self-managed medication abortion cohort with abortion completion reported in historical clinical trials using the same medication regimens, restricted to participants with pregnancies of less than 9 weeks' gestation. This study was registered with ISCRTN, ISRCTN95769543.

findingsBetween July 31, 2019, and April 27, 2020, we enrolled 1051 participants. We analysed abortion outcomes for 961 participants, with an additional 47 participants reached after the study period. Most pregnancies were less than 12 weeks' duration. Participants in follow-up self-managed their abortions using misoprostol alone (593 participants) or the combined regimen of misoprostol plus mifepristone (356 participants). At last follow-up, 586 (99%) misoprostol alone users and 334 (94%) combined regimen users had a complete abortion without surgical intervention. For those with pregnancies of less than 9 weeks' gestation, both regimens were non-inferior to medication abortion effectiveness in clinical settings.

interpretationFindings from this prospective cohort study show that self-managed medication abortion with accompaniment group support is highly effective and, for those with pregnancies of less than 9 weeks' gestation, non-inferior to the effectiveness of clinician-managed medication abortion administered in a clinical setting. These findings support the use of remote self-managed models of early abortion care, as well as telemedicine, as is being considered in several countries because of the COVID-19 pandemic.

fundingDavid and Lucile Packard Foundation. TRANSLATIONS: For the Arabic, French, Bahasa Indonesian, Spanish and Yoruba translations of the Article see Supplementary Materials section.

Indexed as

Abortion, InducedSelf AdministrationAbortifacient AgentsArgentinaCohort StudiesCOVID-19FemaleHumansMifepristoneMisoprostolNigeriaPregnancyProspective StudiesSelf-ManagementSurveys and QuestionnairesAbortifacient AgentsMifepristoneMisoprostol

Identifiers

PMID34801131
PMCPMC9359894
OpenAlexW3215704802

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.