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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05651347
Registration number
NCT05651347
Ethics application status
Date submitted
23/08/2022
Date registered
15/12/2022
Date last updated
15/12/2022
Titles & IDs
Public title
Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction
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Scientific title
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
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Secondary ID [1]
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U1111-1203-6718
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Universal Trial Number (UTN)
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Trial acronym
PROTECTMe
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fetal Growth Retardation
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Stillbirth and Fetal Death
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Pregnancy Preterm
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Condition category
Condition code
Reproductive Health and Childbirth
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Complications of newborn
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Reproductive Health and Childbirth
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Childbirth and postnatal care
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Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Reproductive Health and Childbirth
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Abortion
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Reproductive Health and Childbirth
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Antenatal care
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Placebo
Treatment: Drugs - Melatonin 10 MG
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)
Other interventions: Placebo
Tablets, visually identical to the melatonin tablets, but containing no active ingredient are administered three times a day.
Treatment: Drugs: Melatonin 10 MG
Melatonin 10 mg tablets will be administered three times a day, up to a maximum of 30 mg daily
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Neurodevelopmental performance at 2 years of life among survivors of early onset FGR.
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Assessment method [1]
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The primary outcome will be identified by a change in the Bayley-IV Cognitive score of 5 or more points.
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Timepoint [1]
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24-36 months corrected age
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Secondary outcome [1]
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Incidence of patient reported side effects and adverse events with melatonin use in pregnancy
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Assessment method [1]
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Maternal side effect profiles experienced, such as symptoms of abdominal cramps, flushing, migraines, gastrointestinal disturbance. This will be collected from the patient medication diary completed during treatment with reported side effects expressed as incidence (% patients).
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Timepoint [1]
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From randomisation until cessation of trial medication at birth, assessed for up to 18 weeks.
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Secondary outcome [2]
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Incidence of patient reported daytime somnolence with melatonin use in pregnancy
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Assessment method [2]
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Maternal symptoms of drowsiness, obtained from the patient completed medication diary, will be expressed as an average somnolence score (scale 1-10).
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Timepoint [2]
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From randomisation until cessation of trial medication at birth, assessed for up to 18 weeks.
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Secondary outcome [3]
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Rate of altered maternal end-organ performance with melatonin supplementation
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Assessment method [3]
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Haematological and biochemical investigations undertaken pre- and post- commencement of trial medication will be used to assess the rate of change in maternal end-organ function, particularly renal and liver function.
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Timepoint [3]
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Pre-intervention until 2 weeks post-commencement of intervention
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Secondary outcome [4]
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Impact of melatonin on fetal growth
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Assessment method [4]
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The antenatal use of melatonin on estimated fetal growth (grams) will be assessed using ultrasound biometry parameters performed fortnightly following trial recruitment until birth. The fetal growth trajectory across gestation will be compared to the placebo group.
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Timepoint [4]
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From randomisation until birth, for up to 17 weeks
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Secondary outcome [5]
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Impact of melatonin on fetoplacental Dopplers
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Assessment method [5]
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The antenatal use of melatonin on fetoplacental Dopplers performed fortnightly following trial recruitment until birth. The incidence of abnormal fetoplacental Doppler indices will be reported according to gestational age
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Timepoint [5]
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From randomisation until birth, assessed for up to 17 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/05/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/01/2026
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Actual
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Sample size
Target
336
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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The Canberra Hospital - Garran
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Recruitment hospital [2]
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Royal Prince Alfred - Camperdown
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Recruitment hospital [3]
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John Hunter Hospital - Newcastle
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Recruitment hospital [4]
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Royal Hospital for Women - Randwick
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Recruitment hospital [5]
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Mater Misericordiae - South Brisbane
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Recruitment hospital [6]
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Gold Coast University Hospital - Southport
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Recruitment hospital [7]
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Women's and Children's Hospital - North Adelaide
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Recruitment hospital [8]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [9]
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Eastern Health - Box Hill
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Recruitment hospital [10]
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Monash Health - Clayton
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Recruitment hospital [11]
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Mercy Hospital - Heidelberg
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Recruitment hospital [12]
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Royal Women's Hospital - Parkville
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Recruitment hospital [13]
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Joan Kirner Hospital - Saint Albans
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Recruitment hospital [14]
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King Edward Memorial Hospital - Subiaco
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2305 - Newcastle
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Recruitment postcode(s) [4]
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2031 - Randwick
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Recruitment postcode(s) [5]
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4101 - South Brisbane
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Recruitment postcode(s) [6]
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4215 - Southport
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Recruitment postcode(s) [7]
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5006 - North Adelaide
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Recruitment postcode(s) [8]
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7000 - Hobart
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Recruitment postcode(s) [9]
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3128 - Box Hill
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Recruitment postcode(s) [10]
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3168 - Clayton
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Recruitment postcode(s) [11]
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3084 - Heidelberg
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Recruitment postcode(s) [12]
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3052 - Parkville
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Recruitment postcode(s) [13]
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3021 - Saint Albans
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Recruitment postcode(s) [14]
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6008 - Subiaco
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Country [3]
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New Zealand
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State/province [3]
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Palmerston North
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Country [4]
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New Zealand
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State/province [4]
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Wellington
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Cerebral Palsy Alliance
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Equity Trustees
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT05651347
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kirsten Palmer, PhD
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Address
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Monash University & Monash Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Kirsten Palmer, PhD
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Address
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Country
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Phone
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+61 3 9594 5145
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/47/NCT05651347/Prot_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05651347
Download to PDF