Dataset Information

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

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.

SUBMITTER: Moseson H

PROVIDER: S-EPMC7678383 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Moseson Heidi H Keefe-Oates Brianna B Jayaweera Ruvani T RT Filippa Sofia S Motana Relebohile R Bercu Chiara C Egwuatu Ijeoma I Grosso Belen B Kristianingrum Ika Ayu IA Nmezi Sybil S Zurbriggen Ruth R Friedman Emmeline E Gerdts Caitlin C

BMJ open 20201119 11

<h4>Introduction</h4>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 proc ...[more]

PMID: 33444174

Similar Datasets

Project description:ImportanceMisoprostol-alone regimens for abortion may be more effective than previously thought.ObjectiveTo estimate the effectiveness of medication abortion with misoprostol alone among individuals self-managing their abortion.Design, setting, and participantsFor this prospective observational cohort study of callers to safe abortion hotlines and accompaniment groups in Argentina, Nigeria, and Southeast Asia, participants were recruited between July 31, 2019, and October 1, 2020, prior to starting their medication abortion. Eligible participants were 13 years or older, had no contraindications to medication abortion, and were not currently bleeding. Participants completed a baseline and 2 follow-up surveys. The analysis was restricted to participants who reported using misoprostol alone and was performed between January 6, 2022 and September 8, 2023.ExposureSelf-managed medication abortion using misoprostol alone.Main outcomes and measuresThe primary outcome was effectiveness, defined as participant self-report of complete abortion without procedural intervention, measured at 1 week and 3 weeks after taking misoprostol. Secondary outcomes included method safety, measured by self-report of experiencing warning signs (eg, heavy bleeding, pain, fever, discharge) indicative of a potential complication and by medical treatment (eg, blood transfusion, intravenous fluids, overnight hospital stay) indicative of a potential adverse event. Additional outcomes included length of bleeding and cramping, time to expulsion, and experience of adverse effects.ResultsAmong 1352 enrolled participants, 637 used misoprostol-alone regimens for abortion and were included in the analysis (591 [92.8%] from Nigeria, 45 [7.1%] from Southeast Asia, and 1 [0.2%] from Argentina; 384 [60.2%] aged 20-29 years; 317 [49.8%] with pregnancy durations <7 weeks and 205 [32.2%] with pregnancy durations between 7 and <9 weeks). At last follow-up after taking medication (median, 22 days; IQR, 21-26 days), 625 participants (98.1%; 95% CI, 96.7%-98.9%) had a complete abortion without procedural intervention. Potential adverse events were reported by 6 participants (0.9%; 95% CI, 0.4%-2.1%). Most participants experienced bleeding for less than 1 week (median, 4 days; IQR, 3-6 days) and expelled their pregnancy within 24 hours of starting the abortion process (median, 12 hours; IQR, 9-15 hours). Common side effects included nausea (335 participants [52.6%]), fever (232 [36.4%]), and diarrhea (181 [28.4%]).Conclusions and relevanceThe findings suggest that misoprostol alone is a highly effective method of pregnancy termination. Future research should explore strategies to maximize the effectiveness of misoprostol alone in clinical and nonclinical settings.

Project description:BackgroundA rapid increase in restrictive abortion legislation in the United States has sparked renewed interest in self-managed abortion as a response to clinic access barriers. Yet little is known about knowledge of, interest in, and experiences of self-managed medication abortion among patients who obtain abortion care in a clinic.ObjectivesWe examined patients' knowledge of, interest in, and experience with self-managed medication abortion before presenting to the clinic. We characterized the clinic- and person-level factors associated with these measures. Finally, we examined the reasons why patients express an interest in or consider self-management before attending the clinic.Materials and methodsWe surveyed 1502 abortion patients at 3 Texas clinics in McAllen, San Antonio, and Fort Worth. All individuals seeking abortion care who could complete the survey in English or Spanish were invited to participate in an anonymous survey conducted using iPads. The overall response rate was 90%. We examined the prevalence of 4 outcome variables, both overall and separately by site: (1) knowledge of self-managed medication abortion; (2) having considered self-managing using medications before attending the clinic; (3) interest in medication self-management as an alternative to accessing care at the clinic; and (4) having sought or tried any method of self-management before attending the clinic. We used binary logistic regression models to explore the clinic- and patient-level factors associated with these outcome variables. Finally, we analyzed the reasons reported by those who had considered medication self-management before attending the clinic, as well as the reasons reported by those who would be interested in medication self-management as an alternative to in-clinic care.ResultsAmong all respondents, 30% knew about abortion medications available outside the clinic setting (37% in Fort Worth, 33% in McAllen, 19% in San Antonio, P < .001), and among those with prior knowledge, 28% had considered using this option before coming to the clinic (36% in McAllen, 25% in Fort Worth, 21% in San Antonio, P = .028). Among those without prior knowledge of self-management, 39% expressed interest in this option instead of coming to the clinic (54% in San Antonio, 30% in McAllen, 29% in Fort Worth, P < .001). Overall, 13% had sought out or tried any method of self-management before presenting to the clinic (16% in McAllen and 15% in Fort Worth vs 9% in San Antonio, P < .001). Experiencing barriers to clinic access was associated with having considered medication self-management (odds ratio, 2.2; 95% confidence interval, 1.7-3.0) and with seeking or trying any method of self-management before attending the clinic (odds ratio, 1.9; 95% confidence interval, 1.3-2.7). Difficulty affording the cost of in-clinic care was the most commonly cited reason for having considering medication self-management before attending the clinic. Reasons for interest in medication self-management as an alternative to clinic care included both access barriers and preferences for the privacy and comfort of home.ConclusionConsidering or attempting self-managed abortion may be part of the pathway to seeking in-clinic care, particularly among those experiencing access barriers. However, considerable interest in medication self-management as an alternative to the clinic also suggests a demand for more autonomous abortion care options.

Project description:To validate recent guidance changes by establishing the performance of cut-off values for embryo crown-rump length and mean gestational sac diameter to diagnose miscarriage with high levels of certainty. Secondary aims were to examine the influence of gestational age on interpretation of mean gestational sac diameter and crown-rump length values, determine the optimal intervals between scans and findings on repeat scans that definitively diagnose pregnancy failure.)Prospective multicentre observational trial.Seven hospital based early pregnancy assessment units in the United Kingdom.2845 women with intrauterine pregnancies of unknown viability included if transvaginal ultrasonography showed an intrauterine pregnancy of uncertain viability. In three hospitals this was initially defined as an empty gestational sac <20 mm mean diameter with or without a visible yolk sac but no embryo, or an embryo with crown-rump length <6 mm with no heartbeat. Following amended guidance in December 2011 this definition changed to a gestational sac size <25 mm or embryo crown-rump length <7 mm. At one unit the definition was extended throughout to include a mean gestational sac diameter <30 mm or embryo crown-rump length <8 mm.Mean gestational sac diameter, crown-rump length, and presence or absence of embryo heart activity at initial and repeat transvaginal ultrasonography around 7-14 days later. The final outcome was pregnancy viability at 11-14 weeks' gestation.The following indicated a miscarriage at initial scan: mean gestational sac diameter ? 25 mm with an empty sac (364/364 specificity: 100%, 95% confidence interval 99.0% to 100%), embryo with crown-rump length ? 7 mm without visible embryo heart activity (110/110 specificity: 100%, 96.7% to 100%), mean gestational sac diameter ? 18 mm for gestational sacs without an embryo presenting after 70 days' gestation (907/907 specificity: 100%, 99.6% to 100%), embryo with crown-rump length ? 3 mm without visible heart activity presenting after 70 days' gestation (87/87 specificity: 100%, 95.8% to 100%). The following were indicative of miscarriage at a repeat scan: initial scan and repeat scan after seven days or more showing an embryo without visible heart activity (103/103 specificity: 100%, 96.5% to 100%), pregnancies without an embryo and mean gestational sac diameter <12 mm where the mean diameter has not doubled after 14 days or more (478/478 specificity: 100%, 99.2% to 100%), pregnancies without an embryo and mean gestational sac diameter ? 12 mm showing no embryo heartbeat after seven days or more (150/150 specificity: 100%, 97.6% to 100%).Recently changed cut-off values of gestational sac and embryo size defining miscarriage are appropriate and not too conservative but do not take into account gestational age. Guidance on timing between scans and expected findings on repeat scans are still too liberal. Protocols for miscarriage diagnosis should be reviewed to account for this evidence to avoid misdiagnosis and the risk of terminating viable pregnancies.

Project description:OBJECTIVES:Medication administration errors with injectable medication have a high risk of causing patient harm. To reduce this risk, all Dutch hospitals implemented a protocol for safe injectable medication administration. Nurse compliance with this protocol was evaluated as low as 19% in 2012. The aim of this second evaluation study was to determine whether nurse compliance had changed over a 4-year period, what factors were associated over time with protocol compliance and which strategies have been implemented by hospitals to increase protocol compliance. METHODS:In this prospective observational study, conducted between November 2015 and September 2016, nurses from 16 Dutch hospitals were directly observed during intravenous medication administration. Protocol compliance was complete if nine protocol proceedings were conducted correctly. Protocol compliance was compared with results from the first evaluation. Multilevel logistic regression analyses were used to assess the associations over time between explanatory variables and complete protocol compliance. Implemented strategies were classified according to the five components of the Systems Engineering Initiative for Patient Safety (SEIPS) model. RESULTS:A total of 372 intravenous medication administrations were observed. In comparison with 2012, more proceedings per administration were conducted (mean 7.6, 95% CI 7.5 to 7.7 vs mean 7.3, 95% CI 7.3 to 7.4). No significant change was seen in complete protocol compliance (22% in 2016); compliance with the proceedings 'hand hygiene' and 'check by a second nurse' remained low. In contrast to 2012, the majority of the variance was caused by differences between wards rather than between hospitals. Most implemented improvement strategies targeted the organisation component of the SEIPS model. CONCLUSIONS:Compliance with 'hand hygiene' and 'check by a second nurse' needs to be further improved in order to increase complete protocol compliance. To do so, interventions focused on nurses and individually tailored to each ward are needed.

Project description:ObjectiveTo estimate effectiveness and acceptability of medication abortion with mifepristone dispensed by pharmacists.MethodsWe conducted a prospective cohort study at eight clinical sites and pharmacies in California and Washington State from July 2018 to March 2020. Pharmacists at participating pharmacies underwent a 1-hour training on medication abortion. We approached patients who had already been evaluated, counseled, and consented for medication abortion per standard of care. Patients interested in study participation gave consent, and the clinician electronically sent a prescription to the pharmacy for mifepristone 200 mg orally, followed 24-48 hours later by misoprostol 800 micrograms buccally. Participants were sent web-based surveys about their experience and outcomes on days 2 and 14 after enrollment and had routine follow-up with study sites. We extracted demographic and clinical data, including abortion outcome and adverse events, from medical records. We performed multivariable logistic regression to assess the association of pharmacy experience and other covariates with satisfaction.ResultsWe enrolled 266 participants and obtained clinical outcome information for 262 (98.5%), of whom two reported not taking either medication. Of the 260 participants with abortion outcome information, 252 (96.9%) and 237 (91.2%) completed day 2 and 14 surveys, respectively. Complete medication abortion (primary outcome) occurred for 243 participants (93.5%, 95% CI 89.7-96.1%). Four participants (1.5%, 95% CI 0.4-3.9%) had an adverse event, none of which was serious or related to pharmacist dispensing. In the day 2 survey, 91.3% (95% CI 87.1-94.4%) of participants reported satisfaction with the pharmacy experience. In the day 14 survey, 84.4% (95% CI 79.1-88.8%) reported satisfaction with the medication abortion experience. Those reporting being very satisfied with the pharmacy experience had higher odds of reporting overall satisfaction with medication abortion (adjusted odds ratio 2.96, 95% CI 1.38-6.32).ConclusionPharmacist dispensing of mifepristone for medication abortion is effective and acceptable to patients, with a low prevalence of adverse events.Clinical trial registrationClinicalTrials.gov, NCT03320057.

Dataset Information

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

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets