Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction
Recruiting
Phase 3
Interventional Study
Fetal Growth Retardation
Stillbirth and Fetal Death
Pregnancy Preterm
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 336 (estimated)
- Sponsor
- Monash University · Other
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About This Trial
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 under…
Trial Locations
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Eligibility Criteria
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 l…
Contacts