Protect-me: a parallel-group, triple blinded, placebo-controlled randomised clinical trial protocol assessing antenatal maternal melatonin supplementation for fetal neuroprotection in early-onset fetal growth restriction
Kirsten R Palmer, Joanne C Mockler, Miranda L Davies-Tuck, Suzanne L Miller, Stacy K Goergen, Michael C Fahey, Peter J Anderson, Katie M Groom, Euan M Wallace
BMJ Open | BMJ PUBLISHING GROUP | Published : 2019
INTRODUCTION: Fetal growth restriction (FGR) is a serious pregnancy complication, associated with increased rates of perinatal death and morbidity among survivors. Most commonly FGR results from placental insufficiency, where the placenta fails to deliver the oxygen and nutrients required for normal fetal growth. This leads to fetal oxidative stress, resulting in organ damage through lipid peroxidation. The early developing brain is particularly susceptible, such that FGR is associated with poorer neurodevelopment, witnessed as cognitive and behavioural dysfunction, and cerebral palsy. Promisingly, melatonin, a lipid soluble antioxidant is neuroprotective in animal models of FGR. We present ..View full abstract
The trial is supported by funding from the Cerebral Palsy Alliance (Medical Research Future Fund) and the Equity Trustee's Lynn Quayle Charitable Trust. KRP is funded by a Monash University School of Clinical Sciences Practitioner Fellowship and by the David Healy Clinical Research Fellowship.