What is this PROTECT Me Trial about?

The PROTECT Me Trial is recruiting participants. The trial looks at the use of melatonin to protect the developing brain of babies who were fetal growth restricted (FGR) during pregnancy.

PROTECT Me Trial primary aim

• To determine whether brain development at two years of age is improved among FGR babies whose mothers received melatonin antenatally compared with those who received placebo.

PROTECT Me Trial secondary aims

• To determine the impact of melatonin supplementation on fetal growth and wellbeing.
• To determine whether antenatal melatonin supplementation in fetal growth restriction is associated with less structural brain injuries at term corrected age.
• To report the occurrence of any adverse and serious adverse events associated with melatonin use.

Who can participate?

• You are between 23 and 31⁺⁶ weeks pregnant
• You are having one baby
• Your baby is identified as bring fetal growth restricted (FGR)
• You are over 18 years of age
• You understand English

What will the PROTECT Me Trial involve for participants?

Participation in this trial is completely voluntary. If you are interested, a research midwife from our team will provide you with a Participant Information Sheet & Consent Form to read.

During your pregnancy you will

• Receive either melatonin or placebo capsules to be taken three times daily until your baby is born
• Have blood tests, blood pressure and ultrasound scans performed on site at the time of enrolment, 48 hours later, and then fortnightly until birth (these usually coincide with routine clinical appointments).

After your baby is born they will have

• A general movements assessment (GMA) at their due date and again at three months of age
• A brain MRI around the time of their due date (optional)
• A developmental assessment (Bayley IV) around 2-3 years of age.

This clinical trial has received ethical approval from the Monash Health Human Research Ethics Committee (RES-17-0000-583A).

You will not directly benefit from this study. However, your participation will contribute to world first medical research that may help to improve outcomes for FGR babies in the future.

How do you participate?

As of 30 April 2024, we have recruited 272 participants!

We hope to recruit our final participant by 31 October 2024, or until we reach our recruitment target of 336 participants.

If you are interested in participating or would like more information, please feel free to contact the Protect Me Trial team.

Principal Investigator | A/Prof Kirsten Palmer
Clinical Trial Coordinator | Harriet Dinning
Maternity Clinical Trials Team | (03) 8572 2881
Email | scs-protectme@monash.edu
Twitter/X | @ProtectMeTrial
Monash University

What is fetal growth restriction (FGR)?

Fetal growth restriction (FGR) is a significant health care issue, affecting 20,000 Australian pregnancies every year. FGR is one of the key risk factors for stillbirth and preterm birth, but can also cause significant impairments in short and long-term health outcomes for the child.

One of the main causes of FGR is due to a dysfunctional placenta which may provide less oxygen than what the baby needs to grow normally. This can be harmful to the baby’s brain, as FGR is a major risk for 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. 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.

Trial closes Tuesday, 31 October, 2024. Read more about the trial

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