Background
The WHO 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. This study
protocol describes an RCT that aims to evaluate the efficacy of home-based self-assessment
after a medical abortion and the acceptability and feasibility of the intervention in a lowresource
setting.
Method/Design
The study is a randomised, controlled, non-superiority trial that will evaluate the effectiveness
and acceptability of self-assessment using a low-sensitivity pregnancy test and a checklist two
weeks after medical abortion. 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 self-assessment group will use the low-sensitivity pregnancy test and the
checklist 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. 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 a pictorial instruction sheet for how to use the low-sensitivity
pregnancy test and the checklist of 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 self-assessment, two weeks 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 (No. NCT01827995)
2014.
13th ESC Congress, “Challenges in Sexual and Reproductive Health”, 28-31 maj 2014, Lissabon, Portugal