Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction

Launched by MONASH UNIVERSITY · Dec 6, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating whether melatonin, a natural hormone, can help protect the brain of babies who are not growing properly in the womb, a condition known as fetal growth restriction (FGR). FGR is a serious issue that affects many pregnancies and can lead to problems like stillbirth, preterm birth, and long-term health issues for the child. The study is looking for pregnant women who are between 23 and 31 weeks along and have been diagnosed with severe FGR. Eligible participants must be 18 years or older and able to understand English.

If you join the trial, you will be randomly assigned to receive either melatonin or a placebo (a harmless pill with no active ingredients). This means that neither you nor the researchers will know which one you’re receiving. Throughout the study, you will be monitored closely to see if taking melatonin improves your baby's brain health and future development. This trial is important because, right now, there are no treatments specifically aimed at improving outcomes for babies with fetal growth restriction.

Gender

FEMALE

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

Trial Officials