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Table 2 Primary and secondary trial outcomes

From: Effectiveness of the WHO Safe Childbirth Checklist program in reducing severe maternal, fetal, and newborn harm in Uttar Pradesh, India: study protocol for a matched-pair, cluster-randomized controlled trial

A. Combined maternal, fetal and newborn outcome: composite rate of maternal death by 7 days, intrapartum-related stillbirth, early neonatal death by 7 days, and maternal severe morbidity by 7 days. [Primary outcome]

B. Maternal outcomes: Rate of maternal death (by 7 days), rate of maternal severe morbidity (by 7 days), rate of inter-facility transfer, blood transfusion, hysterectomy, facility revisit, and C-section rate.

C. Newborn outcomes: Rate of intrapartum-related stillbirth, rate of early neonatal death (by 7 days), facility revisit, and rate of inter-facility transfer.

D. Rates of adherence by health workers to essential childbirth practices: In a sample of total births, uptake of the following practices will be assessed: maternal temperature obtained on admission, maternal blood pressure obtained on admission, partograph use, appropriate hand hygiene (use of soap and water, and wearing clean gloves) by health workers before 1st vaginal examination, oxytocin administration within 1 minute after birth, appropriate intervention for the newborn if apneic at birth, newborn weight and temperature obtained within 1 hour after birth, and initiation of breastfeeding within 1 hour after birth.