A randomised controlled trial of antenatal melatonin supplementation in fetal growth restriction for fetal neuroprotection.

Phase 2

Recruiting

• Conditions: Fetal Growth Restriction (FGR); Fetal Neuroprotection; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy; Neurological - Other neurological disorders

• Registration Number: ACTRN12617001515381
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-30
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 336

Inclusion Criteria

1) Women, with a singleton pregnancy
2) Severe fetal growth restriction (FGR), defined as:
Estimated fetal weight equal to, or less than, 3rd centile for gestational age according to charts from Mikolajczyk et al (2011) or an estimated fetal weight that is less than the 10th centile (Mikolajcyk et al 2011) in combination with at least one abnormal fetoplacental doppler study, these being:
-Uterine artery (raised pulsatility index equal to, or more than, 95th centile)
-Umbilical artery (pulsatility index equal to, or more than, 95th centile or absent/reversed end-diastolic flow)
-Ductus venosus (abnormal A wave and/or pulsatility index equal to, or more than, 95th centile)
3) Gestation: (confirmed) 23+0 to 31+6 weeks’
4) Age: 18 years or more
5) Understands English

Reference: Mikolajczyk, R.T., et al., A global reference for fetal-weight and birthweight percentiles. Lancet, 2011. 377 (9780): pp. 1855-61

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 (eg 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 is the trial intervention.

Study & Design

• Study Type: Interventional
• Study Design: Not specified