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Acceptability of home-assessment post medical abortion and medical abortion in a low-resource setting in Rajasthan, India : Secondary outcome analysis of a non-inferiority randomized controlled trial

机译：印度拉贾斯坦邦资源贫乏地区药物流产和药物流产后家庭评估的可接受性：一项非劣效性随机对照试验的次要结果分析

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Background: Studies evaluating acceptability of simplified follow-up after medical abortion have focused on high-resource or urban settings where telephones, road connections, and modes of transport are available and where women have formal education. Objective: To investigate women's acceptability of home-assessment of abortion and whether acceptability of medical abortion differs by in-clinic or home-assessment of abortion outcome in a low-resource setting in India. Design: Secondary outcome of a randomised, controlled, non-inferiority trial. Setting Outpatient primary health care clinics in rural and urban Rajasthan, India. Population: Women were eligible if they sought abortion with a gestation up to 9 weeks, lived within defined study area and agreed to follow-up. Women were ineligible if they had known contraindications to medical abortion, haemoglobin < 85mg/l and were below 18 years. Methods: Abortion outcome assessment through routine clinic follow-up by a doctor was compared with home-assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet. A computerized random number generator generated the randomisation sequence (1: 1) in blocks of six. Research assistants randomly allocated eligible women who opted for medical abortion (mifepristone and misoprostol), using opaque sealed envelopes. Blinding during outcome assessment was not possible. Main outcome measures: Women's acceptability of home-assessment was measured as future preference of follow-up. Overall satisfaction, expectations, and comparison with previous abortion experiences were compared between study groups. Results: 731 women were randomized to the clinic follow-up group (n = 353) or home-assessment group (n = 378). 623 (85%) women were successfully followed up, of those 597 (96%) were satisfied and 592 (95%) found the abortion better or as expected, with no difference between study groups. The majority, 355 (57%) women, preferred home-assessment in the event of a future abortion. Significantly more women, 284 (82%), in the home-assessment group preferred home-assessment in the future, as compared with 188 (70%) of women in the clinic follow-up group, who preferred clinic follow-up in the future (p < 0.001). Conclusion: Home-assessment is highly acceptable among women in low-resource, and rural, settings. The choice to follow-up an early medical abortion according to women's preference should be offered to foster women's reproductive autonomy.
机译：背景：评估堕胎后简化随访的可接受性的研究集中在资源丰富或城市环境中，那里有电话，道路连接和交通方式，并且妇女接受过正规教育。目的：在印度资源匮乏的环境中，调查妇女接受人工流产评估的可接受性以及药物流产的可接受性是否因诊所或人工流产结果的评估而有所不同。设计：随机，对照，非劣效性试验的次要结果。在印度拉贾斯坦邦的农村和城市设立门诊初级卫生保健诊所。人口：如果妇女在妊娠期不超过9周流产，生活在规定的研究区域并同意随访，则符合资格。如果妇女已知有药物流产的禁忌症，血红蛋白<85mg / l并且未满18岁，则不符合资格。方法：将通过医生常规临床随访进行的流产结果评估与使用低敏感性妊娠试验和图片说明表的家庭评估进行比较。一个计算机化的随机数生成器以6块为单位生成随机序列（1：1）。研究助手使用不透明的密封信封随机分配了选择药物流产的合格妇女（米非司酮和米索前列醇）。在结果评估过程中无法致盲。主要结局指标：妇女对家庭评估的接受程度作为对未来随访的偏爱进行衡量。在研究组之间比较了总体满意度，期望值以及与先前流产经验的比较。结果：731名妇女被随机分为临床随访组（n = 353）或家庭评估组（n = 378）。成功随访了623名（85％）妇女，其中597名（96％）感到满意，而592名（95％）发现流产情况更好或符合预期，研究组之间无差异。大多数（355名（57％）妇女）倾向于在将来进行人工流产时进行家庭评估。在家庭评估组中，有284名女性（82％）的女性在未来更倾向于家庭评估，相比之下，在临床随访组中，有188名女性（70％）的女性则更倾向于家庭评估。未来（p <0.001）。结论：在资源贫乏和农村地区的妇女中，家庭评估是高度可接受的。应根据妇女的喜好选择对早期的医学流产进行随访，以促进妇女的生殖自主权。

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