Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction (PROTECTMe)
Fetal Growth Retardation, Stillbirth and Fetal Death, Pregnancy Preterm
About this trial
This is an interventional treatment trial for Fetal Growth Retardation
Eligibility Criteria
Inclusion Criteria: Singleton Pregnancy 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) Confirmed 23+0 - 31+6 weeks' gestation Age ≥18 years Understand English Exclusion Criteria: A fetus with a known chromosomal, major structural anomaly or non-placental cause of fetal growth restriction Pregnancies requiring immediate delivery (e.g. absent A wave in ductus venosus, preterminal CTG or biophysical profile) Co-recruitment in another clinical trial where a pharmaceutical product or nutritional supplement impacting on oxidative stress is the trial intervention. Currently prescribed Fluvoxamine
Sites / Locations
- The Canberra Hospital
- Royal Prince AlfredRecruiting
- John Hunter Hospital
- Royal Hospital for Women
- Mater Misericordiae
- Gold Coast University HospitalRecruiting
- Women's and Children's Hospital
- Royal Hobart Hospital
- Eastern Health
- Monash HealthRecruiting
- Mercy HospitalRecruiting
- Royal Women's HospitalRecruiting
- Joan Kirner HospitalRecruiting
- King Edward Memorial Hospital
- Auckland HospitalRecruiting
- Middlemore HospitalRecruiting
- Christchurch Hospital
- Palmerston Hospital
- Wellington Regional HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
Melatonin
Visually identical placebo tablets containing no active ingredient to the active treatment, administered three times a day.
10mg Melatonin tablets, administered three times a day (a total daily dose of 30mg per day)