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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Fetal growth restriction (FGR) is a significant health care issue, affecting 20,000 Australian pregnancies every year. Undetected FGR is one of the key risk factors for stillbirth, but FGR can also cause significant impairments in short and long-term health outcomes for the child. It is a major risk factor for preterm birth and is a recognised causal pathway to the neurodevelopmental injury underlying cognitive and behavioural impairment and cerebral palsy. Current obstetric care is focused on the detection of the growth restricted fetus and then ultrasound assessment of fetal wellbeing to guide timing of delivery. This approach seeks to maximize the gestational age of the fetus at delivery to minimise the risks of prematurity, while delivering the fetus in time to reduce the likelihood of stillbirth. Currently, no therapies exist that can maximize fetal wellbeing in the setting of growth restriction and minimise the frequency of antenatally acquired brain injury due to in-utero hypoxia. This triple-blind, randomized, parallel group, placebo-controlled trial will administer maternal melatonin or placebo supplementation antenatally in the setting of early-onset severe FGR to determine whether melatonin can PROTECT the fetal brain and lead to improved neurodevelopmental outcomes.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Australia
Royal Prince Alfred
RECRUITING
Camperdown
Monash Health
RECRUITING
Clayton
Mercy Hospital
RECRUITING
Heidelberg
John Hunter Hospital
RECRUITING
Newcastle
Women's and Children's Hospital
RECRUITING
North Adelaide
Royal Women's Hospital
RECRUITING
Parkville
Joan Kirner Hospital
RECRUITING
Saint Albans
Mater Misericordiae
RECRUITING
South Brisbane
Gold Coast University Hospital
RECRUITING
Southport
New Zealand
Auckland Hospital
RECRUITING
Auckland
Middlemore Hospital
RECRUITING
Auckland
Wellington Regional Hospital
RECRUITING
Wellington
Contact Information
Primary
Kirsten Palmer, PhD
kirsten.palmer@monash.edu
+61 3 9594 5145
Time Frame
Start Date: 2019-05-29
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 336
Treatments
Placebo_comparator: Placebo
Visually identical placebo tablets containing no active ingredient to the active treatment, administered three times a day.
Active_comparator: Melatonin
10mg Melatonin tablets, administered three times a day (a total daily dose of 30mg per day)
Sponsors
Collaborators: Cerebral Palsy Alliance, National Health and Medical Research Council, Australia, Equity Trustees
Leads: Monash University

This content was sourced from clinicaltrials.gov