RecruitingPhase 4ACTRN12612000858897

Melatonin to prevent brain injury in unborn growth restricted babies

A pilot study of maternally administered melatonin to decrease the level of oxidative stress in human pregnancies affected by intrauterine growth restriction.


Sponsor

Monash University

Enrollment

12 participants

Start Date

Sep 7, 2012

Study Type

Interventional

Conditions

Summary

Intrauterine growth restriction is the term used to describe a condition where an unborn baby does not reach its optimum size. In the short and long term, intrauterine growth restricted babies have a higher risk of serious disease and even death. It is well established that very low levels of oxygen in the baby's blood can harm the baby's health through a state known as oxidative stress. Currently, there is no established treatment available to treat intrauterine growth restriction or its complications. In experimental animal studies however, the naturally occuring hormone, melatonin, has been shown to significantly reduce oxidative stress and improve health of the unborn babies that have suffered from intrauterine growth restriction. This study aims to find out if the use melatonin twice per day throughout pregnancies affected by intrauterine growth restriction will lower the level of oxidative stress experienced by the unborn baby. If this is the case melatonin may help protect the unborn baby from damage caused by oxidative stress, this will be studied in a separate future study.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether melatonin taken twice daily during pregnancy can protect the brain of an unborn baby that is not growing properly (called intrauterine growth restriction, or IUGR). When a baby does not get enough oxygen in the womb, it can cause oxidative stress that damages developing organs. Melatonin is a naturally occurring hormone that has been shown in animal studies to reduce this damage. You may be eligible if: - You are pregnant and aged 18 to 45 - Your baby is measuring below the 10th percentile for size with abnormal blood flow on ultrasound - You are carrying a single baby - You are between 23 and 34 weeks pregnant - Your baby has a normal anatomy scan and there is no immediate need to deliver - You have a basic understanding of English You may NOT be eligible if: - You are carrying twins or more - Your baby has a known chromosome abnormality or birth defect - The cause of your baby's small size is not related to the placenta - The length of your pregnancy is not confirmed Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

4mg prolonged release melatonin oral tablets twice daily. Treatment will occur as soon as the diagnosis of intrauterine growth restriction is made and the patient has been enrolled to this study until

4mg prolonged release melatonin oral tablets twice daily. Treatment will occur as soon as the diagnosis of intrauterine growth restriction is made and the patient has been enrolled to this study until birth. The overall duration of treatment will vary due to the nature of intrauterine growth restriction.


Locations(1)

Australia

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ACTRN12612000858897