Self-assessment of the outcome of early medical abortion versus clinic follow-up in India: a randomised, controlled, non-inferiority trial.
BACKGROUND
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Department of Women's and Children's Health, Division of Obstetrics and Gynaecology, Karolinska Institutet/Karolinska University Hospital, WHO Collaborating Centre, Stockholm, Sweden; Action Research and Training for Health (ARTH), Udaipur, Rajasthan, India. Electronic address: kirti.iyengar@ki.se.
Kirti
K
Iyengar
Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
Mandira
M
Paul
Action Research and Training for Health (ARTH), Udaipur, Rajasthan, India.
Sharad D
SD
Iyengar
Department of Women's and Children's Health, Division of Obstetrics and Gynaecology, Karolinska Institutet/Karolinska University Hospital, WHO Collaborating Centre, Stockholm, Sweden; School of Education, Health and Social Studies, Dalarna University, Falun, Sweden.
Marie
M
Klingberg-Allvin
Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
Birgitta
B
Essén
Statisticon, Stockholm, Sweden.
Johan
J
Bring
Action Research and Training for Health (ARTH), Udaipur, Rajasthan, India.
Sunita
S
Soni
Department of Women's and Children's Health, Division of Obstetrics and Gynaecology, Karolinska Institutet/Karolinska University Hospital, WHO Collaborating Centre, Stockholm, Sweden.
Kristina
K
Gemzell-Danielsson
D000019:Abortifacient Agents / Q000627:therapeutic use*; D000028:Abortion, Induced / Q000379:methods*; D000328:Adult; D000359:Aftercare / Q000379:methods; D000554:Ambulatory Care Facilities; D059026:Diagnostic Self Evaluation; D005260:Female; D006699:Home Care Services; D006801:Humans; D007194:India; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011247:Pregnancy; D011258:Pregnancy Tests / Q000379:methods*; D055815:Young Adult
D000019:Abortifacient Agents