Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction

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.

Conditions

• Fetal Growth Retardation
• Stillbirth and Fetal Death
• Pregnancy Preterm

Interventions

OTHER

Placebo

Tablets, visually identical to the melatonin tablets, but containing no active ingredient are administered three times a day.

DRUG

Melatonin 10 MG

Melatonin 10 mg tablets will be administered three times a day, up to a maximum of 30 mg daily

Sponsors & Collaborators

• National Health and Medical Research Council, Australia

  collaborator OTHER

• Cerebral Palsy Alliance

  collaborator OTHER

• Equity Trustees

  collaborator UNKNOWN

• Monash University

  lead OTHER

Principal Investigators

• Kirsten Palmer, PhD · Monash University & Monash Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-05-29

Primary Completion

2027-04-30

Completion

2027-04-30

Countries

• Australia
• New Zealand

Study Locations