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  • Iyengar, KirtiKarolinska Institutet (författare)

Self-assessment of the outcome of early medical abortion versus clinic follow-up in India : a randomised, controlled, non-inferiority trial

  • Artikel/kapitelEngelska2015

Förlag, utgivningsår, omfång ...

  • 2015
  • electronicrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:du-19528
  • https://urn.kb.se/resolve?urn=urn:nbn:se:du-19528URI
  • https://doi.org/10.1016/S2214-109X(15)00150-3DOI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-263448URI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:131932191URI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • 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.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Paul, MandiraUppsala universitet,Internationell kvinno- och mödrahälsovård och migration(Swepub:uu)manpa544 (författare)
  • Iyengar, Sharad D.ARTH, Udaipur, Rajasthan, India. (författare)
  • Klingberg-Allvin, MarieKarolinska 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.(Swepub:du)mkl (författare)
  • Essén, BirgittaUppsala universitet,Internationell kvinno- och mödrahälsovård och migration(Swepub:uu)bires412 (författare)
  • Bring, JohanStatisticon, Stockholm, Sweden. (författare)
  • Soni, SunitaARTH, Udaipur, Rajasthan, India. (författare)
  • Gemzell-Danielsson, KristinaKarolinska Institutet (författare)
  • Karolinska InstitutetInternationell kvinno- och mödrahälsovård och migration (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:The Lancet Global Health3:9, s. E537-E5452214-109X

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