Paul Mandira, Iyengar Kirti, Essén Birgitta, Gemzell-Danielsson Kristina, Iyengar Sharad D, Bring Johan, Soni Sunita, Klingberg-Allvin Marie
Department of Women's and Children's health, Uppsala University, Uppsala, Sweden.
Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet/ Karolinska University Hospital, Stockholm, Sweden; Action Research & Training for Health (ARTH), Udaipur, Rajasthan, India.
PLoS One. 2015 Sep 1;10(9):e0133354. doi: 10.1371/journal.pone.0133354. eCollection 2015.
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.
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.
Secondary outcome of a randomised, controlled, non-inferiority trial.
Outpatient primary health care clinics in rural and urban Rajasthan, India.
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 < 85 mg/l and were below 18 years.
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.
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.
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).
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.
ClinicalTrials.gov NCT01827995.
评估药物流产后简化随访可接受性的研究主要集中在资源丰富或城市地区，这些地区有电话、道路连接和交通方式，且女性接受过正规教育。
在印度资源匮乏地区，调查女性对流产家庭评估的可接受性，以及药物流产的可接受性是否因流产结局的门诊评估或家庭评估而有所不同。
一项随机对照非劣效性试验的次要结局。
印度拉贾斯坦邦农村和城市的门诊初级卫生保健诊所。
妊娠9周以内寻求流产、居住在规定研究区域内并同意随访的女性符合入选标准。已知有药物流产禁忌证、血红蛋白<85mg/l以及年龄<18岁的女性不符合入选标准。
将医生进行的常规门诊随访流产结局评估与使用低灵敏度妊娠试验和图片说明书的家庭评估进行比较。通过计算机随机数字生成器以六个一组的方式生成随机化序列（1:1）。研究助手使用不透明密封信封对选择药物流产（米非司酮和米索前列醇）的符合条件女性进行随机分配。结局评估期间无法实施盲法。
将女性对家庭评估的可接受性作为未来随访的偏好进行测量。比较研究组之间的总体满意度、期望以及与既往流产经历的比较。
731名女性被随机分为门诊随访组（n = 353）或家庭评估组（n = 378）。623名（85%）女性成功完成随访，其中597名（96%）表示满意，592名（95%）认为流产情况较好或符合预期，两组之间无差异。大多数女性，即355名（57%），表示如果未来再次流产，更倾向于家庭评估。家庭评估组中显著更多的女性，即284名（82%），表示未来更倾向于家庭评估，而门诊随访组中只有188名（70%）女性表示未来更倾向于门诊随访（p < 0.001）。
在资源匮乏的农村地区，家庭评估在女性中具有很高的可接受性。应根据女性的偏好提供早期药物流产随访选择，以促进女性的生殖自主权。
ClinicalTrials.gov NCT01827995。
