NCT05651347 Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction
| NCT ID | NCT05651347 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Monash University |
| Condition | Fetal Growth Retardation |
| Study Type | INTERVENTIONAL |
| Enrollment | 336 participants |
| Start Date | 2019-05-29 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 336 participants in total. It began in 2019-05-29 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Singleton Pregnancy 2. 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) 3. Confirmed 23+0 - 31+6 weeks' gestation 4. Age ≥18 years 5. Understand English Exclusion Criteria: 1. A fetus with a known chromosomal, major structural anomaly or non-placental cause of fetal growth restriction 2. Pregnancies requiring immediate delivery (e.g. absent A wave in ductus venosus, preterminal CTG or biophysical profile) 3. Co-recruitment in another clinical trial where a pharmaceutical product or nutritional supplement impacting on oxidative stress is the trial intervention. 4. Currently prescribed Fluvoxamine
Contact & Investigator
Kirsten Palmer, PhD
PRINCIPAL INVESTIGATOR
Monash University & Monash Health
Frequently Asked Questions
Who can join the NCT05651347 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Fetal Growth Retardation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05651347 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 336 participants.
Is NCT05651347 currently recruiting?
Yes, NCT05651347 is actively recruiting participants. Contact the research team at kirsten.palmer@monash.edu for enrollment information.
Where is the NCT05651347 trial being conducted?
This trial is being conducted at Camperdown, Australia, Newcastle, Australia, South Brisbane, Australia, Southport, Australia and 8 additional locations.
Who is sponsoring the NCT05651347 clinical trial?
NCT05651347 is sponsored by Monash University. The principal investigator is Kirsten Palmer, PhD at Monash University & Monash Health. The trial plans to enroll 336 participants.