Clinical Trial: Melatonin to Prevent Brain Injury in Unborn Growth Restricted Babies

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Pilot Study of Maternally Administered Melatonin to Decrease the Level of Oxidative Stress in Human Pregnancies Affected by Intrauterine Growth Restriction.

Brief 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.

Detailed Summary:
Sponsor: Monash University

Current Primary Outcome: Oxidative stress in the umbilical artery [ Time Frame: Once, at birth. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Oxidative stress in maternal venous serum [ Time Frame: Once within one week before start treatment and once per week during the treatment period (estimated to be an average of 4 weeks). ]
  Maternal serum oxidative stress will be assessed by measuring levels of malondialdehyde (MDA) and 8-isoprostane. Levels of MDA will be assessed using a Thiobarbituric Acid Reactive Substances Assay Kit (Cayman Chemical Item Number 10009055). Levels of 8-isoprostane will be assessed using an 8-Isoprostane Enzyme Immuno Assay Kit (Cayman Chemical Item Number 516351).
• Fetoplacental Doppler studies [ Time Frame: Once within one week before start treatment and twice per week during the treatment period (estimated to be an average of 4 weeks). ]
  Fetoplacental Doppler studies (umbilical artery, uterine artery, middle cerebral artery, ductus venosus). Fetoplacental Doppler studies are performed in the clinical assessment of women diagnosed with intrauterine growth restriction by sonography.
• Placental oxidative stress [ Time Frame: Once, at birth. ]
  Placental oxidative stress is assessed by measuring levels of malondialdehyde (MDA) and 8-isoprostane. Levels of MDA will be assessed using a Thiobarbituric Acid Reactive Substances Assay Kit (Cayman Chemical Item Number 10009055). Levels of 8-isoprostane will be assessed using an 8-Isoprostane Enzyme Immuno Assay Kit (Cayman Chemical Item Number 516351)
• Gestational age at birth. [ Time Frame: Once, at birth. ]
  Gestational age at birth will be calculated using the last menstrual period and ultrasound characteristics.
• Composite neonatal outcome. [ Time Frame: Participants will be followed for the duration of hospital stay, up to 12 months. ]
  Composite neonatal outcome (admission to NICU, duration of admission, need and duration of respiratory support, intraventricular haemorrhage, necrotising enterocolitis, abnormal neurological assessment, mortality before discharge). This composite neonatal outcome will be measured by collecting medical record data after clinical assessments.

Original Secondary Outcome: Same as current

Information By: Monash University

Dates:
Date Received: September 7, 2012
Date Started: September 2012
Date Completion:
Last Updated: November 14, 2014
Last Verified: November 2014