Table 1.

Summary of the study procedures and timelines

Procedure	At admission (baseline)	1 hour after onset of study drug administration	At birth	At 7 days postpartum	At 14 days postpartum
Assessment of eligibility	x
Randomisation	x
Data collection for baseline parameters	x
Study drug administration	x
Questionnaire administration	x	x	x	x	x
Data collection for primary outcome		x	x
Data collection for secondary outcome			x	x	x