Table 2.

Schedule of study procedures

	Antenatal Care visits	During labour/pre delivery	Post delivery/pre discharge	3-day postpartum (pp)	7-day pp	14-day pp	28-day pp	42-day pp
Community sensitisation	X
Screening
Eligibility confirmation		X
Clinical assessment		X
Consent		X
Randomisation		X
Drug administration		X
Baseline data collection
Sociodemographic information		X	X
Medical history		X	X
Labour and delivery (L&D) information			X
Monitoring
Drug side effects*		X	X	X	X			X
Maternal events during L&D		X	X
Neonatal events during L&D			X
Maternal infection/sepsis*			X	X	X			X
Neonatal infection/sepsis*			X	X	X			X
Maternal death*			X	X	X			X
Stillbirth or neonatal death<28 days of birth*			X	X	X	X	X	X
Infant mortality≥28 days of birth*								X
Pyloric stenosis*			X	X	X			X
Other maternal outcomes*			X	X	X			X
Other neonatal outcomes*			X	X	X			X
Unintended medical visits*			X	X	X			X
Serious adverse events*			X	X	X			X

*Events that may be reported by participant between scheduled study visits.