Academic paper: Self-assessment of the outcome of early medical abortion versus clinic follow-up in India: a randomised, controlled, non-inferiority trial.
Kirti Iyengar K, Mandira Paul, Sharad Iyengar, et al.Lancet Global Health 2015;3:e537–45.AbstractThe 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. This study compared the effectiveness of standard clinic follow-up versus home assessment of outcome of medical abortion in a low-resource setting.The study was a randomised, controlled, non-inferiority trial, done in six health centres (three rural, three urban) in Rajasthan, India. Women seeking early medical abortion up to 9 weeks of pregnancy were randomly assigned to either routine clinic follow-up or self-assessment at home. Randomisation was done by computer. 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. They were contacted by a home visit or telephone call to record the outcome of the abortion….Findings: Between 23 April 2013 and 15 May 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.Interpretation: 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.VISUALSEE ALSO: Randomized trial assessing home use of two pregnancy tests for determining early medical abortion outcomes at 3, 7 and 14 days after mifepristone, by Jennifer Blum et al. Contraception 2016;94(2):115-21.