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  • 1.
    Paul, Mandira
    et al.
    Uppsala Universitet.
    Iyengar, Kirti
    Karolinska Institutet.
    Iyengar, Sharad
    Actiona for Reserach in Health (ARTH), India.
    Essen, Birgitta
    Uppsala Universitet.
    Gemzell-Danielsson, Kristina
    Karolinska Institutet.
    Klingberg-Allvin, Marie
    Högskolan Dalarna, Akademin Utbildning, hälsa och samhälle, Omvårdnad.
    Simplified follow-up after medical abortion using a low-sensitivity urinary pregnancy test and a pictorial instruction sheet in Rajasthan, India: study protocol and intervention adaptation of a randomised control trial2014Ingår i: BMC Women's Health, ISSN 1472-6874, E-ISSN 1472-6874, Vol. 14, artikel-id 98Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    The World Health Organisation suggests that simplification of the medical abortion regime will contribute to an increased acceptability of medical abortion, among women as well as providers. It is expected that a home-based follow-up after a medical abortion will increase the willingness to opt for medical abortion as well as decrease the workload and service costs in the clinic.

    Trial design

    The study is a randomised, controlled, non-superiority trial .

    Methods

    Women screened to participate in the study are those with unwanted pregnancies and gestational ages equal to or less than nine weeks. Eligible women randomised to the home-based assessment group will use a low-sensitivity pregnancy test and a pictorial instruction sheet at home, while the women in the clinic follow-up group will return to the clinic for routine follow-up carried out by a doctor. The primary objective of the study is to evaluate the effectiveness of home-based assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet 10-14 days after an early medical abortion. Providers or research assistants will not be blinded during outcome assessment. To ensure feasibility of the self-assessment intervention an adaption phase took place at the selected study sites before study initiation. This was to optimise and tailor-make the intervention and the study procedures and resulted in the development of the pictorial instruction sheet for how to use the low-sensitivity pregnancy test and the danger signs after a medical abortion.

    Discussion

    In this paper, we will describe the study protocol for a randomised control trial investigating the efficacy of simplified follow-up in terms of home-based assessment, 10-14 days after a medical abortion. Moreover, a description of the adaptation phase is included for a better understanding of the implementation of the intervention in a setting where literacy is low and the road-connections are poor. Trial registration: Clinicaltrials.gov NCT01827995. Registered 04 May 2013

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