Actively Recruiting
Led by Monash University · Updated on 2025-06-06
336
Participants Needed
12
Research Sites
N/A
Total Duration
M
Monash University
Lead Sponsor
N
National Health and Medical Research Council, Australia
Collaborating Sponsor
Fetal growth restriction (FGR) affects many pregnancies and is linked to serious risks including stillbirth, preterm birth, and long-term developmental challenges such as cerebral palsy. This trial evaluates whether giving pregnant women melatonin can protect the fetal brain and improve neurodevelopmental outcomes in babies affected by early-onset severe FGR. The study is a triple-blind, randomized, placebo-controlled trial aiming to address the lack of treatments to enhance fetal wellbeing before birth. Participants will receive either melatonin tablets (10 mg three times daily for a total of 30 mg per day) or matching placebo tablets three times a day. The trial includes pregnancies diagnosed with severe FGR between 23 and 31 weeks gestation. Treatment continues until birth. The study is conducted across multiple centers, with participant groups randomized based on gestational age to allow sub-analysis of early and late onset FGR. Participants will be monitored throughout pregnancy with assessments of fetal growth and placental blood flow. After birth, children's neurodevelopment will be evaluated at 2 years of age using the Bayley-IV Cognitive scale. Researchers will also track side effects, maternal organ function, and fetal wellbeing until birth. The total participation duration varies depending on gestational age at enrollment and follow-up visits extend to 2-3 years of the child's life for outcome measurement.
CONDITIONS
Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 17 weeks or until birth
Participants receive melatonin or placebo tablets three times a day during pregnancy until birth to evaluate neuroprotective effects in fetal growth restriction.
Regular visits during treatment as determined by clinical care
Duration - 24 to 36 months corrected age
Participants and their children are followed up to assess neurodevelopmental outcomes at 2 years of age among survivors.
1 to 2 visits depending on neurodevelopmental assessment schedule
Total: 12 locations
1
Royal Prince Alfred
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
2
John Hunter Hospital
Newcastle, New South Wales, Australia, 2305
Actively Recruiting
3
Mater Misericordiae
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
4
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Actively Recruiting
5
Women's and Children's Hospital
North Adelaide, South Australia, Australia, 5006
Actively Recruiting
6
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
7
Mercy Hospital
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
8
Royal Women's Hospital
Parkville, Victoria, Australia, 3052
Actively Recruiting
9
Joan Kirner Hospital
Saint Albans, Victoria, Australia, 3021
Actively Recruiting
10
Auckland Hospital
Auckland, New Zealand, 1023
Actively Recruiting
11
Middlemore Hospital
Auckland, New Zealand, 2025
Actively Recruiting
12
Wellington Regional Hospital
Wellington, New Zealand, 6021
Actively Recruiting
K
Kirsten Palmer, PhD
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Kirsten R Palmer, Joanne C Mockler, Miranda L Davies-Tuck...
https://pubmed.ncbi.nlm.nih.gov/31230020