Using melatonin to protect the brain in pregnancies with fetal growth restriction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.