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- Paul, Mandira, et al.
(författare)
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Simplified Follow-up after Medical Abortion using a Low-sensitivity Urinary Pregnancy Test and a Checklist in Rajasthan, India – Study Protocol and Intervention adaptation of a Randomised Control Trial
- 2014
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Konferensbidrag (refereegranskat)abstract
- BackgroundThe WHO suggests that simplification of the medical abortion regime will contribute to anincreased acceptability of medical abortion, among women as well as providers. It is expectedthat a home-based follow-up after a medical abortion will increase the willingness to opt formedical abortion as well as decrease the workload and service costs in the clinic. This studyprotocol describes an RCT that aims to evaluate the efficacy of home-based self-assessmentafter a medical abortion and the acceptability and feasibility of the intervention in a lowresourcesetting.Method/DesignThe study is a randomised, controlled, non-superiority trial that will evaluate the effectivenessand acceptability of self-assessment using a low-sensitivity pregnancy test and a checklist twoweeks after medical abortion. Women screened to participate in the study are those withunwanted pregnancies and gestational ages equal to or less than nine weeks. Eligible womenrandomised to the self-assessment group will use the low-sensitivity pregnancy test and thechecklist at home, while the women in the clinic follow-up group will return to the clinic forroutine follow-up carried out by a doctor. To ensure feasibility of the self-assessmentintervention 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 resultedin the development of a pictorial instruction sheet for how to use the low-sensitivitypregnancy test and the checklist of danger signs after a medical abortion.DiscussionIn this paper, we will describe the study protocol for a randomised control trial investigatingthe efficacy of simplified follow-up in terms of home-based self-assessment, two weeks aftera medical abortion. Moreover, a description of the adaptation phase is included for a betterunderstanding of the implementation of the intervention in a setting where literacy is low andthe road-connections are poor.Trial registrationClinicaltrials.gov (No. NCT01827995)
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