Melatonin supplementation effect on the Induction of labour rates in first-time MothErs: The MyTIME Trial

Problem: In the last 10 years, rates of induction of labour amongst first-time (nulliparous) mothers have increased by 43%, from 32% to 46%. Situated in the context of soaring medical costs, few significant improvements in perinatal outcomes have been realised in the last decade. Despite escalated investment and medical intervention, rates of stillbirths, neonatal deaths and maternal mortality remain largely unchanged. Conversely, rates of maternal and neonatal morbidity have increased, with rising rates of induction of labour, caesarean section, epidural, episiotomy, postpartum haemorrhage, maternal and neonatal birth trauma and sepsis. Evidence indicates that induction of labour in the absence of medical compromise may increase the risk for iatrogenic harm to the mother and baby. Solution: Melatonin, a hormone released by the pineal gland, is essential for healthy spontaneous labour. Whilst it is naturally produced in the body at night, contemporary environmental impacts such as increased exposure to blue light and shorter sleep periods compete with melatonin production and release. This proposed clinical trial (randomised, double-blind, placebo-controlled trial) will test what would be a high-impact, high-value, low-cost solution aimed at potentiating spontaneous labour and reducing the rates of labour induction. This meets both the requirements for reducing unnecessary interventions while addressing some of the safety concerns about the risks associated with pregnancy extending beyond 41 weeks as outlined below. The aim is to determine if oral supplementation with 3mg melatonin from 39 weeks gestation in nulliparous women will reduce the induction of labour rates. Our unpublished consumer data indicate high acceptability and strong maternal demand for this proposed innovative approach,85% of women surveyed indicated they would be interested in participating if this exact trial were available to them.