The Melatonin in Pregnancy Study
Can mum taking a melatonin supplement during pregnancy when baby has fetal growth restriction protect baby’s brain and lead to improved learning and development in childhood?
Recruitment for the Melatonin in Pregnancy Study (also known as PROTECT Me) is now complete. We are very grateful to all the whānau who joined the study. We are now in the ‘follow-up’ phase which includes assessment of children born to those who took part in the study, once they reach two years of age.
Study title: a Randomised Controlled Trial of Antenatal Melatonin Supplementation in Fetal Growth Restriction for Fetal Neuroprotection. ‘PROTECT Me’.
What is the purpose of this study?
Fetal Growth Restriction (FGR) is a condition where baby does not grow at the rate that would be expected during pregnancy. There are many causes of FGR, but the most common cause is because the placenta (whenua) is not working as well as it should. This may result in the baby receiving lower levels of oxygen (‘oxidative stress’), which may be harmful to the baby’s developing brain. Currently there are no treatments available to minimise or prevent this stress on the developing brain of an FGR baby during pregnancy.
What is melatonin?
Melatonin is a naturally occurring hormone in the human body. It is an anti-oxidant that may be able to protect the FGR baby’s developing brain from low oxygen levels (‘oxidative stress’). While this is the first large trial of melatonin for fetal neuroprotection in FGR, melatonin has been used safely in previous trials in pregnancy.
This brief infographic video tells you a little more about the trial.
Who is organising this research?
This project is led by researchers from Monash Health and Monash University, Melbourne. It is being conducted in hospitals across New Zealand and Australia. Funding has been provided by a number of ‘public good’ funders including Monash University, The Cerebral Palsy Alliance and the National Health and Medical Research Council (NHMRC), Australia.
Contact us
Auckland team
Local investigator: Professor Katie Groom
Research midwives: 021 0831 4824
Research coordinator, Elisa Tam: 022 4311 988
Email: elisa.tam@auckland.ac.nz
This study has received ethical approval from the Northern B Health and Disability Ethics Committee, reference 20/NTB/137.