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Self-assessment of ...
Self-assessment of the outcome of early medical abortion versus clinic follow-up in India : a randomised, controlled, non-inferiority trial
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- Iyengar, Kirti (author)
- Karolinska Institutet
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- Paul, Mandira (author)
- Uppsala universitet,Internationell kvinno- och mödrahälsovård och migration
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- Iyengar, Sharad D. (author)
- ARTH, Udaipur, Rajasthan, India.
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- Klingberg-Allvin, Marie (author)
- Karolinska Institutet,Uppsala universitet,Högskolan Dalarna,Omvårdnad,Karolinska institutet,Internationell kvinno- och mödrahälsovård och migration,Karolinska Inst, Dept Womens & Childrens Hlth, WHO Collaborating Ctr, Div Obstet & Gynaecol,Karolinska Univ Hosp, SE-17176 Stockholm, Sweden.;Dalarna Univ, Sch Educ Hlth & Social Studies, Falun, Sweden.
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- Essén, Birgitta (author)
- Uppsala universitet,Internationell kvinno- och mödrahälsovård och migration
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- Bring, Johan (author)
- Statisticon, Stockholm, Sweden.
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- Soni, Sunita (author)
- ARTH, Udaipur, Rajasthan, India.
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- Gemzell-Danielsson, Kristina (author)
- Karolinska Institutet
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(creator_code:org_t)
- 2015
- 2015
- English.
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In: The Lancet Global Health. - 2214-109X. ; 3:9, s. E537-E545
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Abstract
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- Background: The need for multiple clinical visits remains a barrier to women accessing safe legal medical abortion services. Alternatives to routine clinic follow-up visits have not been assessed in rural low-resource settings. We compared the effectiveness of standard clinic follow-up versus home assessment of outcome of medical abortion in a low-resource setting.Methods: This randomised, controlled, non-inferiority trial was done in six health centres (three rural, three urban) in Rajasthan, India. Women seeking early medical abortion up to 9 weeks of gestation were randomly assigned (1:1) to either routine clinic follow-up or self-assessment at home. Randomisation was done with a computer-generated randomisation sequence, with a block size of six. The study was not blinded. Women in the home-assessment group were advised to use a pictorial instruction sheet and take a low-sensitivity urine pregnancy test at home, 10-14 days after intake of mifepristone, and were contacted by a home visit or telephone call to record the outcome of the abortion. The primary (non-inferiority) outcome was complete abortion without continuing pregnancy or need for surgical evacuation or additional mifepristone and misoprostol. The non-inferiority margin for the risk difference was 5%. All participants with a reported primary outcome and who followed the clinical protocol were included in the analysis. This study is registered with ClinicalTrials.gov, number NCT01827995.Findings: Between April 23, 2013, and May 15, 2014, 731 women were recruited and assigned to clinic follow-up (n=366) or home assessment (n=365), of whom 700 were analysed for the main outcomes (n=336 and n=364, respectively). Complete abortion without continuing pregnancy, surgical intervention, or additional mifepristone and misoprostol was reported in 313 (93%) of 336 women in the clinic follow-up group and 347 (95%) of 364 women in the home-assessment group (difference -2.2%, 95% CI -5.9 to 1.6). One case of haemorrhage occurred in each group (rate of adverse events 0.3% in each group); no other adverse events were noted. Interpretation Home assessment of medical abortion outcome with a low-sensitivity urine pregnancy test is non-inferior to clinic follow-up, and could be introduced instead of a clinic follow-up visit in a low-resource setting.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Arbetsmedicin och miljömedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Occupational Health and Environmental Health (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Public Health, Global Health, Social Medicine and Epidemiology (hsv//eng)
Keyword
- Hälsa och välfärd
- Health and Welfare
Publication and Content Type
- ref (subject category)
- art (subject category)
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