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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 trial
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). (Internationell kvinno- & mödrahälsovård och migration/Essén)
Department of Women’s and Children’s Health, Karolinska Institutet, University Hospital, Stockholm, Sweden.
Division of Reproductive Health at Action Research, Training for Health (ARTH) Society, Udaipur, India.
Department of Women’s and Children’s Health, Karolinska Institutet, University Hospital, Stockholm, Sweden.
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2014 (English)In: BMC Women's Health, ISSN 1472-6874, E-ISSN 1472-6874, Vol. 14, 98- p.Article in journal (Refereed) Published
Abstract [en]

BACKGROUND

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.

METHODS/DESIGN

This study protocol describes a study that is a randomised, controlled, non-superiority trial. Women screened to participate in the study are those with unwanted pregnancies and gestational ages equal to or less than nine weeks. The randomisation list will be generated using a computerized random number generator and opaque sealed envelopes with group allocation will be prepared. Randomization of the study participants will occur after the first clinical encounter with the doctor. 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 this study protocol describes is to evaluate the efficacy 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 resulted in an optimized, tailor-made intervention and in the development of the pictorial instruction sheet with a guide on 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.

Place, publisher, year, edition, pages
2014. Vol. 14, 98- p.
National Category
Public Health, Global Health, Social Medicine and Epidemiology
Identifiers
URN: urn:nbn:se:uu:diva-230832DOI: 10.1186/1472-6874-14-98ISI: 000340652200001PubMedID: 25127545OAI: oai:DiVA.org:uu-230832DiVA: diva2:742029
Funder
Swedish Research Council, 2011-3525
Available from: 2014-08-29 Created: 2014-08-29 Last updated: 2017-12-05Bibliographically approved

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