Using melatonin to protect the brain in pregnancies with fetal growth restriction
A Triple-blinded, Randomized, Parallel-group Placebo-controlled Trial to Assess the Impact of Maternal Antenatal Melatonin Supplementation on Early Childhood Neurodevelopmental Outcomes in the Setting of Severe Preterm Fetal Growth Restriction
This study is testing if giving melatonin to pregnant women with severe fetal growth restriction can help improve their baby's health and protect against brain injury before birth.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Monash University Academic / other |
| Locations | 12 sites (Camperdown, New South Wales and 11 other locations) |
| Trial ID | NCT05651347 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of antenatal melatonin supplementation in pregnant women experiencing severe fetal growth restriction (FGR). The study aims to determine whether melatonin can improve fetal wellbeing and reduce the risk of brain injury associated with in-utero hypoxia. Participants will receive either melatonin or a placebo during the critical weeks leading up to delivery, with assessments focused on fetal health and development. The trial is designed to provide insights into a potential new therapy that could enhance outcomes for infants born under these challenging conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older, between 23 and 31 weeks of gestation, with singleton pregnancies diagnosed with severe fetal growth restriction.
Not a fit: Patients with known chromosomal or major structural anomalies in the fetus, or those requiring immediate delivery due to critical fetal conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of brain injury and improve long-term health outcomes for infants born with fetal growth restriction.
How similar studies have performed: While magnesium sulphate has shown some success in improving fetal brain development in similar contexts, the use of melatonin for this purpose is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Camperdown, New South Wales and 11 other locations
- Royal Prince Alfred — Camperdown, New South Wales, Australia (Recruiting)
- John Hunter Hospital — Newcastle, New South Wales, Australia (Recruiting)
- Mater Misericordiae — South Brisbane, Queensland, Australia (Recruiting)
- Gold Coast University Hospital — Southport, Queensland, Australia (Recruiting)
- Women's and Children's Hospital — North Adelaide, South Australia, Australia (Recruiting)
- Monash Health — Clayton, Victoria, Australia (Recruiting)
- Mercy Hospital — Heidelberg, Victoria, Australia (Recruiting)
- Royal Women's Hospital — Parkville, Victoria, Australia (Recruiting)
- Joan Kirner Hospital — Saint Albans, Victoria, Australia (Recruiting)
- Auckland Hospital — Auckland, New Zealand (Recruiting)
- Middlemore Hospital — Auckland, New Zealand (Recruiting)
- Wellington Regional Hospital — Wellington, New Zealand (Recruiting)
Study contacts
- Principal investigator: Kirsten Palmer, PhD — Monash University & Monash Health
- Study coordinator: Kirsten Palmer, PhD
- Email: kirsten.palmer@monash.edu
- Phone: +61 3 9594 5145
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.