Abstract
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. 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. 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. 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.
Highlights
First trimester medical abortion has been recognised as a safe and effective method for induced termination of pregnancy;[1,2] it remains inaccessible for many women in low-resource settings
Women with unwanted pregnancies opting for medical abortion were eligible to participate in the study if their gestational age was 9 weeks or less as estimated by bimanual pelvic examination, if they resided in an area where follow-up was possible or they had access to a telephone on which they could talk privately, and who agreed to a follow-up after 2 weeks, by either telephone or home visit
At the time of analysis, we detected that 15 women in the clinic followup group as per the randomisation list were allocated to the home assessment group, and two women in the home assessment group as per the randomisation list were allocated to the clinic follow-up group because of an error in randomisation by research assistants
Summary
First trimester medical abortion has been recognised as a safe and effective method for induced termination of pregnancy;[1,2] it remains inaccessible for many women in low-resource settings. Reduced access to safe abortion leads women to seek unsafe abortion, an important cause of maternal mortality worldwide.[3] In India, 8% of maternal deaths result from unsafe abortion; this proportion is slightly higher (10%) in the group of states that includes Rajasthan.[4] An important factor affecting access and acceptability of medical abortion in women is the number of required clinical visits.[5,6] The need for a routine follow-up visit to a clinic can be especially burdensome for women with low autonomy and limited financial resources, which is often the situation in low-resource settings. Several clinical guidelines for medical abortion require women to return for a followup visit.[7,8]
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