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Self-assessment of the outcome of early medical abortion versus clinic follow-up in India: a randomised, controlled, non-inferiority trial
Karolinska Inst, Dept Womens & Childrens Hlth, WHO Collaborating Ctr, Div Obstet & Gynaecol,Karolinska Univ Hosp, SE-17176 Stockholm, Sweden.;ARTH, Udaipur, Rajasthan, India..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, International Maternal and Child Health (IMCH).
ARTH, Udaipur, Rajasthan, India..
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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2015 (English)In: LANCET GLOBAL HEALTH, ISSN 2214-109X, Vol. 3, no 9, E537-E545 p.Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2015. Vol. 3, no 9, E537-E545 p.
National Category
Environmental Health and Occupational Health Public Health, Global Health, Social Medicine and Epidemiology
Identifiers
URN: urn:nbn:se:uu:diva-263448ISI: 000360559500019PubMedID: 26275330OAI: oai:DiVA.org:uu-263448DiVA: diva2:859294
Funder
Swedish Research Council, 2011-3525
Available from: 2015-10-06 Created: 2015-09-30 Last updated: 2016-01-13Bibliographically approved
In thesis
1. Simplifying Reproductive Health in Low-Resource Settings: Access to medical abortion and contraceptive choice, the importance of gendered structures in Rajasthan
Open this publication in new window or tab >>Simplifying Reproductive Health in Low-Resource Settings: Access to medical abortion and contraceptive choice, the importance of gendered structures in Rajasthan
2015 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

India introduced family planning in the ‘50s, legalized abortion in the ‘70s, and accomplished a remarkable drop in maternal mortality and fertility since 1990. Nevertheless, abortions account for a large proportion of maternal deaths, and sterilization is the most frequently used contraception. This thesis aims to identify the means to simplify and increase access to reproductive health in low-resource settings, focusing on abortion and contraception in Rajasthan.

A randomized controlled trial compared simplified follow-up, where women assess their abortion outcome at home after early medical abortion, with in-clinic follow-up. Additionally, contraceptive use was compared between study groups post-abortion. In order to explore young women’s opportunities to access reproductive health services in the area, we conducted in-depth interviews with recently-married women.

Women in the home-assessment group preferred home-assessment in the future to a greater extent than the women in the clinic follow-up group, who preferred in-clinic follow-up. Complete abortions were reported in 95% of women in the ‘home-assessment group’ and 93% in the ‘in-clinic group’, suggesting that efficacy of simplified follow-up is non-inferior to in-clinic follow-up. A majority (81%) of women carried out the pregnancy test and found it easy to use. Women (96%) were satisfied with their abortion. There were no differences in contraceptive use between study groups at three months; however, women in the ‘in-clinic group’ were most likely to initiate contraception at two weeks. A majority of women preferred the three-month injection, while only 4% preferred sterilization. The recently-married women considered reversible contraception to be unfeasible due to misconceptions and taboos, yet women wanted effective contraception because their current use of traditional methods resulted in unintended pregnancies. Abortions were common, and were procured from private or informal providers.

Allowing women to take an active role in reproductive health services can enable simplification of, and access to, reproductive services in low-resource settings as well as in other settings. Simplifying medical abortion, providing contraception ‘intra-abortion’, and offering a context-appropriate and effective means of contraception, creates a great potential to increase access to reproductive health services and can result in a more equal society where women, and men, can attain their sexual and reproductive rights.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2015. 144 p.
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1163
Keyword
Medical abortion, Contraception, Access, Simplified, Gender, Sexual and reproductive health and rights, India
National Category
Public Health, Global Health, Social Medicine and Epidemiology Health Care Service and Management, Health Policy and Services and Health Economy Obstetrics, Gynecology and Reproductive Medicine
Research subject
International Health
Identifiers
urn:nbn:se:uu:diva-267167 (URN)978-91-554-9414-8 (ISBN)
Public defence
2016-01-11, Gustavianum, Akademigatan 3, Uppsala, 13:00 (English)
Opponent
Supervisors
Available from: 2015-12-14 Created: 2015-11-18 Last updated: 2016-01-13

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Paul, MandiraEssén, Birgitta

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