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New treatment option for Fetal Growth Retardation
Official title Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction
ClinicalTrials.gov ID: NCT05651347
What this study is testing
What is Melatonin 10 MG?
Melatonin 10 MG is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for fetal growth retardation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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)
You likely can't join if
- 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...
- Currently prescribed Fluvoxamine
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Camperdown, New South Wales, Australia
- Newcastle, New South Wales, Australia
- South Brisbane, Queensland, Australia
- Southport, Queensland, Australia
- North Adelaide, South Australia, Australia
- Clayton, Victoria, Australia
- Heidelberg, Victoria, Australia
- Parkville, Victoria, Australia
- Saint Albans, Victoria, Australia
- Auckland, New Zealand
- Wellington, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Camperdown, New South Wales, Australia; Newcastle, New South Wales, Australia; South Brisbane, Queensland, Australia; Southport, Queensland, Australia; North Adelaide, South Australia, Australia; Clayton, Victoria, Australia and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.