Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Fetal Growth Retardation, Stillbirth and Fetal Death, Pregnancy Preterm
In brief
Fetal growth restriction (FGR) is a significant health care issue, affecting 20,000 Australian pregnancies every year. Undetected FGR is one of the key risk factors for stillbirth, but FGR can also cause significant impairments in short and long-term health outcomes for the child. It is a major risk factor for preterm birth and is a recognised causal pathway to the neurodevelopmental injury underlying cognitive and behavioural impairment and cerebral palsy. Current obstetric care is focused on the detection of the growth restricted fetus and then ultrasound assessment of fetal wellbeing to guide timing of delivery. This approach seeks to maximize the gestational age of the fetus at delivery to minimise the risks of prematurity, while delivering the fetus in time to reduce the likelihood of stillbirth. Currently, no therapies exist that can maximize fetal wellbeing in the setting of growth restriction and minimise the frequency of antenatally acquired brain injury due to in-utero hypoxia. This triple-blind, randomized, parallel group, placebo-controlled trial will administer maternal melatonin or placebo supplementation antenatally in the setting of early-onset severe FGR to determine whether melatonin can PROTECT the fetal brain and lead to improved neurodevelopmental outcomes.
Key facts
- Study ID
- NCT05651347
- Run by
- Monash University
- People needed
- 336
- Starts
- 2019-05-29
- Expected to finish
- 2027-04-30
- Last updated by the study team
- 2025-06-06
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Singleton Pregnancy
- Severe fetal growth restriction, defined as:
- Abdominal circumference ≤3rd centile for gestational age according to charts supplied that have been adapted from Westerway et al; or
- Abdominal circumference <10th centile in combination with at least one abnormal fetoplacental Doppler study, being:
- Uterine artery (raised pulsatility index ≥95th centile)
- Umbilical artery (pulsatility index ≥95th centile or absent/reversed end-diastolic flow)
- Confirmed 23+0 - 31+6 weeks' gestation
- Age ≥18 years
- Understand English
You may not qualify if…
- A fetus with a known chromosomal, major structural anomaly or non-placental cause of fetal growth restriction
- Pregnancies requiring immediate delivery (e.g. absent A wave in ductus venosus, preterminal CTG or biophysical profile)
- Co-recruitment in another clinical trial where a pharmaceutical product or nutritional supplement impacting on oxidative stress is the trial intervention.
- Currently prescribed Fluvoxamine
Where it is running
- Royal Prince Alfred — Camperdown, New South Wales, Australia (enrolling)
- John Hunter Hospital — Newcastle, New South Wales, Australia (enrolling)
- Mater Misericordiae — South Brisbane, Queensland, Australia (enrolling)
- Gold Coast University Hospital — Southport, Queensland, Australia (enrolling)
- Women's and Children's Hospital — North Adelaide, South Australia, Australia (enrolling)
- Monash Health — Clayton, Victoria, Australia (enrolling)
- Mercy Hospital — Heidelberg, Victoria, Australia (enrolling)
- Royal Women's Hospital — Parkville, Victoria, Australia (enrolling)
- Joan Kirner Hospital — Saint Albans, Victoria, Australia (enrolling)
- Auckland Hospital — Auckland, New Zealand (enrolling)
- Middlemore Hospital — Auckland, New Zealand (enrolling)
- Wellington Regional Hospital — Wellington, New Zealand (enrolling)
Full record on ClinicalTrials.gov
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