Ibis Reproductive Health, 1736 Franklin Street, Suite 600, Oakland, CA, 94612, USA.
Department of Epidemiology and Biostatistics, University of California, San Francisco, USA.
Reprod Health. 2020 Oct 27;17(1):164. doi: 10.1186/s12978-020-01016-4.
To evaluate the feasibility of conducting a prospective study to measure self-managed medication abortion outcomes, and to collect preliminary data on safety and effectiveness of self-managed medication abortion, we recruited callers to accompaniment groups (volunteer networks that provide counselling through the out-of-clinic medication abortion process by trained counselors over the phone or in-person).
In 2019, we enrolled callers to three abortion accompaniment groups in three countries into a prospective study on the safety and effectiveness of self-managed medication abortion with accompaniment support. Participants completed up to five interview-administered questionnaires from baseline through 6-weeks after taking the pills. Primary outcomes included: (1) the number of participants enrolled in a 30-day period, (2) the proportion that had a complete abortion; and (3) the proportion who experienced any warning signs of potential or actual complications.
Over the 30-day recruitment period, we enrolled 227 participants (95% of those invited), and retained 204 participants (90%) for at least one study follow-up visit. At the 1-week follow-up, two participants (1%) reported a miscarriage prior to taking the pills, and 202 participants (89% of those enrolled and 99% of those who participated in the 1-week survey) had obtained and taken the medications. Three weeks after taking the medications, 192 (95%) participants reported feeling that their abortion was complete. Three (1.5%) received a surgical intervention, two (1%) received antibiotics, and five (3%) received other medications. Participants did not report any major adverse events.
These results establish the feasibility of conducting prospective studies of self-managed medication abortion in legally restrictive settings. Further, the high effectiveness of self-managed medication abortion with accompaniment support reported here is consistent with high levels of effectiveness reported in prior studies. Trial registration ISRCTN95769543.
为了评估开展前瞻性研究以衡量自我管理药物流产结局的可行性，并收集关于自我管理药物流产安全性和有效性的初步数据，我们招募了陪同组的来电者（志愿网络，通过培训过的顾问通过电话或面对面的方式在诊所外的药物流产过程中提供咨询）。
2019 年，我们招募了来自三个国家的三个流产陪同组的来电者参加一项关于自我管理药物流产安全性和有效性的前瞻性研究，该研究有陪同支持。参与者从基线到服药后 6 周内最多完成了五次访谈式问卷。主要结局包括：（1）在 30 天期间招募的参与者人数；（2）完全流产的比例；（3）出现任何潜在或实际并发症警告迹象的比例。
在 30 天的招募期间，我们招募了 227 名参与者（邀请人数的 95%），并保留了 204 名参与者（90%）至少进行了一次研究随访。在第 1 周随访时，两名参与者（1%）报告在服药前流产，202 名参与者（登记人数的 89%和参加第 1 周调查的 99%）已经获得并服用了药物。服药后 3 周，192 名（95%）参与者报告感觉流产已完成。3 人（1.5%）接受了手术干预，2 人（1%）接受了抗生素治疗，5 人（3%）接受了其他药物治疗。参与者没有报告任何重大不良事件。
这些结果确立了在法律限制环境下开展自我管理药物流产前瞻性研究的可行性。此外，这里报告的有陪同支持的自我管理药物流产的高有效性与之前研究报告的高水平有效性一致。试验注册 ISRCTN95769543。
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