Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Melatonin to Prevent Brain Injury in Unborn Growth Restricted Babies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01695070
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Nicole Alers, Monash University

Tracking Information
First Submitted Date  ICMJE September 7, 2012
First Posted Date  ICMJE September 27, 2012
Last Update Posted Date November 18, 2014
Study Start Date  ICMJE September 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2012)
Oxidative stress in the umbilical artery [ Time Frame: Once, at birth. ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2012)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Melatonin to Prevent Brain Injury in Unborn Growth Restricted Babies
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fetal Growth Retardation
Intervention  ICMJE Drug: Melatonin
4mg prolonged release melatonin oral tablets twice daily
Other Name: Circadin
Study Arms  ICMJE 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.
Intervention: Drug: Melatonin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2014)
16
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2012)
12
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01695070
Other Study ID Numbers  ICMJE U1111-1133-4541
ACTRN12612000858897 ( Registry Identifier: Australian New Zealand Clinical Trial Registry )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nicole Alers, Monash University
Study Sponsor  ICMJE Monash University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Monash University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP