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Study identifier: NCT05651347 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction

Condition: Fetal Growth Retardation · Stillbirth and Fetal Death · Pregnancy Preterm  ·  Sponsor: Monash University

PhasePhase 3
Planned participants336
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Kirsten Palmer, PhD  ·  +61 3 9594 5145  ·  kirsten.palmer@monash.edu

Always discuss trial participation with your own doctor first.

Locations (12)

Royal Prince AlfredCamperdown, New South Wales, AustraliaRecruiting
John Hunter HospitalNewcastle, New South Wales, AustraliaRecruiting
Mater MisericordiaeSouth Brisbane, Queensland, AustraliaRecruiting
Gold Coast University HospitalSouthport, Queensland, AustraliaRecruiting
Women's and Children's HospitalNorth Adelaide, South Australia, AustraliaRecruiting
Monash HealthClayton, Victoria, AustraliaRecruiting
Mercy HospitalHeidelberg, Victoria, AustraliaRecruiting
Royal Women's HospitalParkville, Victoria, AustraliaRecruiting
Joan Kirner HospitalSaint Albans, Victoria, AustraliaRecruiting
Auckland HospitalAuckland, New ZealandRecruiting
Middlemore HospitalAuckland, New ZealandRecruiting
Wellington Regional HospitalWellington, New ZealandRecruiting

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Source record: clinicaltrials.gov/study/NCT05651347