Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01695070
Registration number
NCT01695070
Ethics application status
Date submitted
7/09/2012
Date registered
27/09/2012
Date last updated
18/11/2014
Titles & IDs
Public title
Melatonin to Prevent Brain Injury in Unborn Growth Restricted Babies
Query!
Scientific title
A Pilot Study of Maternally Administered Melatonin to Decrease the Level of Oxidative Stress in Human Pregnancies Affected by Intrauterine Growth Restriction.
Query!
Secondary ID [1]
0
0
ACTRN12612000858897
Query!
Secondary ID [2]
0
0
U1111-1133-4541
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Fetal Growth Retardation
0
0
Query!
Condition category
Condition code
Reproductive Health and Childbirth
0
0
0
0
Query!
Fetal medicine and complications of pregnancy
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Melatonin
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.
Treatment: Drugs: Melatonin
4mg prolonged release melatonin oral tablets twice daily
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Oxidative stress in the umbilical artery
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
Once, at birth.
Query!
Secondary outcome [1]
0
0
Oxidative stress in maternal venous serum
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
Once within one week before start treatment and once per week during the treatment period (estimated to be an average of 4 weeks).
Query!
Secondary outcome [2]
0
0
Fetoplacental Doppler studies
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Once within one week before start treatment and twice per week during the treatment period (estimated to be an average of 4 weeks).
Query!
Secondary outcome [3]
0
0
Placental oxidative stress
Query!
Assessment method [3]
0
0
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)
Query!
Timepoint [3]
0
0
Once, at birth.
Query!
Secondary outcome [4]
0
0
Gestational age at birth.
Query!
Assessment method [4]
0
0
Gestational age at birth will be calculated using the last menstrual period and ultrasound characteristics.
Query!
Timepoint [4]
0
0
Once, at birth.
Query!
Secondary outcome [5]
0
0
Composite neonatal outcome.
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Participants will be followed for the duration of hospital stay, up to 12 months.
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
45
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Fetal demise.
* Multiple pregnancy.
* Known abnormal karyotype.
* Presence of any congenital abnormality.
* Unknown duration of pregnancy.
* IUGR attributable to non-placental factors.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/11/2014
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
16
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Southern Health: Monash Medical Centre and Jessie McPherson Private Hospital - Clayton
Query!
Recruitment postcode(s) [1]
0
0
3168 - Clayton
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Monash University
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01695070
Query!
Trial related presentations / publications
Miller SL, Yawno T, Alers NO, Castillo-Melendez M, Supramaniam VG, VanZyl N, Sabaretnam T, Loose JM, Drummond GR, Walker DW, Jenkin G, Wallace EM. Antenatal antioxidant treatment with melatonin to decrease newborn neurodevelopmental deficits and brain injury caused by fetal growth restriction. J Pineal Res. 2014 Apr;56(3):283-94. doi: 10.1111/jpi.12121. Epub 2014 Feb 22. Alers NO, Jenkin G, Miller SL, Wallace EM. Antenatal melatonin as an antioxidant in human pregnancies complicated by fetal growth restriction--a phase I pilot clinical trial: study protocol. BMJ Open. 2013 Dec 23;3(12):e004141. doi: 10.1136/bmjopen-2013-004141.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Nicole O Alers, MD
Query!
Address
0
0
The Ritchie Centre, Monash Institute of Medical Research, Monash University
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01695070
Download to PDF