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Melatonin to Prevent Brain Injury in Unborn Growth Restricted Babies

NCT01695070 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-11-18

No results posted yet for this study

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.

Conditions

  • Fetal Growth Retardation

Interventions

DRUG

Melatonin

4mg prolonged release melatonin oral tablets twice daily

Sponsors & Collaborators

Principal Investigators

  • Nicole O Alers, MD · The Ritchie Centre, Monash Institute of Medical Research, Monash University

  • Euan M Wallace, MBChB MD FRCOG FRANZCOG · Southern Health, The Ritchie Centre, Monash Institute of Medical Research, Monash University

  • Graham Jenkin, BSc PhD · The Ritchie Centre, Monash Institute of Medical Research

  • Suzanne L Miller, BSc PhD · The Ritchie Centre, Monash Institute of Medical Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-10-31
Completion
2014-11-30

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01695070 on ClinicalTrials.gov