Background

Telemedicine for medical abortion increases access to safe abortion but its use has not been described in a controlled trial. We aimed to investigate the effectiveness, adherence, safety, and acceptability of a modified telemedicine protocol for abortion compared with standard care in a low-resource setting.

Methods

In this randomised, controlled, non-inferiority trial we recruited women seeking medical abortion at or before 9 gestational weeks at four public health clinics in South Africa. Participants were randomly allocated (1:1) by computer-generated blocks of varying sizes to telemedicine or standard care. The telemedicine group received asynchronous online abortion consultation and instruction, self-assessed gestational duration, and had a uterine palpation as a safety measure. Participants in this group took 200 mg mifepristone and 800 μg misoprostol at home. The standard care group received in-person consultation and instruction together with an ultrasound, took 200 mg mifepristone in clinic and 800 μg misoprostol at home. Our primary outcome was complete abortion after initial treatment, assessed at a 6-week interview. Our non-inferiority margin was 4%. Group differences were assessed by modified intention-to-treat (mITT) analysis and per protocol. The trial is registered at ClinicalTrials.gov, NCT04336358, and the Pan African Clinical Trials Registry, PACTR202004661941593.

Findings

Between Feb 28, 2020, and Oct 5, 2021, we enrolled 900 women, 153 (17·0%) of whom were discontinued before the abortion and were not included in the analysis. By mITT analysis, 355 (95·4%) of 372 women in the telemedicine group had a complete abortion compared with 338 (96·6%) of 350 in the standard care group (odds ratio 0·74 [95% CI 0·35 to 1·57]). The risk difference was –1·1% (–4·0 to 1·7). Among women who completed treatment as allocated (per protocol), 327 (95·6%) of 342 women in telemedicine group had complete abortion, compared with 338 (96·6%) of 350 in the standard care group (0·77 [0·36 to 1·68]), with a risk difference of –1·0% (–3·8 to 1·9). One participant (in the telemedicine group) had a ruptured ectopic pregnancy, and a further four participants were admitted to hospital (two in each group), of whom two had blood transfusions (one in each group).

Interpretation

Asynchronous online consultation and instruction for medical abortion and home self-medication, with uterine palpation as the only in-person component, was non-inferior to standard care with respect to rates of complete abortion, and did not affect safety, adherence, or satisfaction.

Funding

Grand Challenges Canada and the Swedish Research Council.

中文翻译：

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南非堕胎的远程医疗模型：一项随机、对照、非劣效性试验

背景

用于药物流产的远程医疗增加了获得安全流产的机会，但尚未在对照试验中描述其使用。我们旨在调查在资源匮乏的情况下，与标准护理相比，修改后的堕胎远程医疗方案的有效性、依从性、安全性和可接受性。

方法

在这项随机、对照、非劣效性试验中，我们在南非的四家公共卫生诊所招募了在妊娠 9 周或之前寻求药物流产的女性。通过计算机生成的不同大小的块，参与者被随机分配（1:1）到远程医疗或标准护理。远程医疗组接受异步在线流产咨询和指导，自我评估孕期，并进行子宫触诊作为安全措施。该组的参与者在家中服用了 200 mg 米非司酮和 800 μg 米索前列醇。标准护理组接受面对面咨询和指导以及超声检查，在诊所服用 200 mg 米非司酮和在家服用 800 μg 米索前列醇。我们的主要结果是初始治疗后完全流产，在为期 6 周的访谈中评估。我们的非劣效性差值为 4%。通过改良意向治疗 (mITT) 分析和每个方案评估组差异。该试验已在 ClinicalTrials.gov 注册，NCT04336358 和泛非临床试验注册中心 PACTR202004661941593。

发现

在 2020 年 2 月 28 日至 2021 年 10 月 5 日期间，我们招募了 900 名女性，其中 153 名 (17·0%) 在流产前停药且未纳入分析。通过 mITT 分析，远程医疗组 372 名女性中有 355 名（95·4%）完全流产，而标准护理组 350 名女性中有 338 名（96·6%）（优势比 0·74 [95% CI 0· 35 至 1·57]）。风险差异为 –1·1%（–4·0 到 1·7）。在完成分配（按方案）治疗的女性中，远程医疗组 342 名女性中有 327 名（95·6%）完全流产，而标准护理组 350 名女性中有 338 名（96·6%）（0·77 [ 0·36 到 1·68]），风险差异为 –1·0%（–3·8 到 1·9）。一名参与者（远程医疗组）异位妊娠破裂，另有四名参与者住院（每组两名），

解释

药物流产和家庭自我药疗的异步在线咨询和指导，以子宫触诊作为唯一的现场组件，在完全流产率方面不劣于标准护理，并且不影响安全性、依从性或满意度.

资金

加拿大大挑战和瑞典研究委员会。