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BACKGROUND:In India, although the proportion of institutional births is increasing, there are concerns regarding quality of care. We assessed the effectiveness of a nurse-led onsite mentoring program in improving quality of care of institutional births in 24/7 primary health centres (PHCs that are open 24 hours a day, 7 days a week) of two high priority districts in Karnataka state, South India. Primary outcomes were improved facility readiness and provider preparedness in managing institutional births and associated complications during child birth. METHODS:All functional 24/7 PHCs in the two districts were included in the study. We used a parallel, cluster randomized trial design in which 54 of 108 facilities received six onsite mentoring visits, along with an initial training update and specially designed case sheets for providers; the control arm received just the initial training update and the case sheets. Pre- and post-intervention surveys were administered in April-2012 and August-2013 using facility audits, provider interviews and case sheet audits. The provider interviews were administered to all staff nurses available at the PHCs and audits were done of all the filled case sheets during the month prior to data collection. In addition, a cost analysis of the intervention was undertaken. RESULTS:Between the surveys, we achieved coverage of 100% of facilities and 91.2% of staff nurse interviews. Since the case sheets were newly designed, case-sheet audit data were available only from the end line survey for about 80.2% of all women in the intervention facilities and 57.3% in the control facilities. A higher number of facilities in the intervention arm had all appropriate drugs, equipment and supplies to deal with gestational hypertension (19 vs.3, OR (odds ratio) 9.2, 95% C.I 2.5 to33.6), postpartum haemorrhage (29 vs. 12, OR 3.7, 95% C.I 1.6 to8.3); and obstructed labour (25 vs.9, OR 3.4, 95% CI 1.6 to8.3). The providers in the intervention arm had better knowledge of active management of the third stage of labour (82.4% vs.35.8%, AOR (adjusted odds ratio) 10, 95% C.I 5.5 to 18.2); management of maternal sepsis (73.5% vs. 10.9%, AOR 36.1, 95% C.I 13.6 to 95.9); neonatal resuscitation (48.5% vs.11.7%, AOR 10.7, 95% C.I 4.6 to 25.0) and low birth weight newborn care (58.1% vs. 40.9%, AOR 2.4, 95% C.I 1.2 to 4.7). The case sheet audits revealed that providers in the intervention arm showed greater compliance with the protocols during labour monitoring (77.3% vs. 32.1%, AOR 25.8, 95% C.I 9.6 to 69.4); delivery and immediate post-partum care for mothers (78.6% vs. 31.8%, AOR 22.1, 95% C.I 8.0 to 61.4) and for newborns (73.9% vs. 32.8%, AOR 24.1, 95% C.I 8.1 to 72.0). The cost analysis showed that the intervention cost an additional $5.60 overall per delivery. CONCLUSIONS:The mentoring program successfully improved provider preparedness and facility readiness to deal with institutional births and associated complications. It is feasible to improve the quality of institutional births at a large operational scale, without substantial incremental costs. TRIAL REGISTRATION:ClinicalTrials.gov NCT02004912.