Table 1

Inclusion and exclusion criteria

InclusionExclusion
NulliparousWomen with indications for induction of labour (IOL) or caesarean section prior to 40 weeks and 10 days because of medical and/or obstetric complications
Singleton, live pregnancyAny known fetal congenital abnormality or compromise/condition that would necessitate admission to neonatal intensive care unit after birth
Cephalic presentationWomen with diagnosed fetal death in utero at recruitment
No clinical indication for IOL at time of recruitmentAny known sensitivity or adverse reaction to melatonin or excipients in melatonin formulation
Awaiting onset of spontaneous labourFetal growth restriction (abdominal circumference or estimated fetal weight <10th centile) with abnormal dopplers
Not planning a scheduled birth before 41 weeks’ gestation unless subsequently indicatedWomen with gestational diabetes mellitus taking metformin or insulin, or those with type I or II diabetes
Age 16 and overUnable/unwilling to follow direction in participant information and consent form
Able to provide written informed consent to participate in the clinical trialUnable to provide informed consent (mentally, legally, cognitively incapacitated)
Co-recruitment in another trial where there are competing pharmaceutical or nutritional interventions
Currently taking a medication known to influence melatonin pharmacokinetics or bioavailability