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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
Scientific title
A Pilot Study of Maternally Administered Melatonin to Decrease the Level of Oxidative Stress in Human Pregnancies Affected by Intrauterine Growth Restriction.
Secondary ID [1] 0 0
ACTRN12612000858897
Secondary ID [2] 0 0
U1111-1133-4541
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fetal Growth Retardation 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Oxidative stress in the umbilical artery
Timepoint [1] 0 0
Once, at birth.
Secondary outcome [1] 0 0
Oxidative stress in maternal venous serum
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).
Secondary outcome [2] 0 0
Fetoplacental Doppler studies
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).
Secondary outcome [3] 0 0
Placental oxidative stress
Timepoint [3] 0 0
Once, at birth.
Secondary outcome [4] 0 0
Gestational age at birth.
Timepoint [4] 0 0
Once, at birth.
Secondary outcome [5] 0 0
Composite neonatal outcome.
Timepoint [5] 0 0
Participants will be followed for the duration of hospital stay, up to 12 months.

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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Southern Health: Monash Medical Centre and Jessie McPherson Private Hospital - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01695070
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.
Public notes

Contacts
Principal investigator
Name 0 0
Nicole O Alers, MD
Address 0 0
The Ritchie Centre, Monash Institute of Medical Research, Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01695070