Melatonin to Prevent Brain Injury in Unborn Growth Restricted Babies

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Monash University
Sponsor:
Information provided by (Responsible Party):
Nicole Alers, Monash University
ClinicalTrials.gov Identifier:
NCT01695070
First received: September 7, 2012
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Fetal Growth Retardation
Drug: Melatonin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Maternally Administered Melatonin to Decrease the Level of Oxidative Stress in Human Pregnancies Affected by Intrauterine Growth Restriction.

Resource links provided by NLM:


Further study details as provided by Monash University:

Primary Outcome Measures:
  • Oxidative stress in the umbilical artery [ Time Frame: Once, at birth. ] [ Designated as safety issue: No ]
    Umbilical artery oxidative stress 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).


Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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). ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 12
Study Start Date: September 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melatonin
Women with IUGR will take 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.
Drug: Melatonin
4mg prolonged release melatonin oral tablets twice daily
Other Name: Circadin

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Estimated fetal weight <10th percentile in combination with abnormal fetoplacental Doppler studies.
  • Singleton pregnancy.
  • Live fetus.
  • Gestational age: from 23+0 weeks until 34+0 weeks.
  • Normal fetal anatomy on ultrasound.
  • Confirmed gestational age.
  • No indication for immediate delivery.
  • Basic understanding of the English language.
  • 18 years or older.
  • Consent obtained.

Exclusion Criteria:

  • Fetal demise.
  • Multiple pregnancy.
  • Known abnormal karyotype.
  • Presence of any congenital abnormality.
  • Unknown duration of pregnancy.
  • IUGR attributable to non-placental factors.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695070

Contacts
Contact: Nicole O Alers, MD +61416000539 nicole.alers@monash.edu

Locations
Australia, Victoria
Southern Health: Monash Medical Centre and Jessie McPherson Private Hospital Recruiting
Clayton, Victoria, Australia, 3168
Contact: Nicole O Alers, MD    +61416000539    nicole.alers@monash.edu   
Principal Investigator: Nicole O Alers, MD         
Sponsors and Collaborators
Monash University
Investigators
Principal Investigator: Nicole O Alers, MD The Ritchie Centre, Monash Institute of Medical Research, Monash University
Principal Investigator: Euan M Wallace, MBChB MD FRCOG FRANZCOG Southern Health, The Ritchie Centre, Monash Institute of Medical Research, Monash University
Principal Investigator: Graham Jenkin, BSc PhD The Ritchie Centre, Monash Institute of Medical Research
Principal Investigator: Suzanne L Miller, BSc PhD The Ritchie Centre, Monash Institute of Medical Research
  More Information

No publications provided

Responsible Party: Nicole Alers, MD, Monash University
ClinicalTrials.gov Identifier: NCT01695070     History of Changes
Other Study ID Numbers: U1111-1133-4541, ACTRN12612000858897
Study First Received: September 7, 2012
Last Updated: September 26, 2012
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014