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Melatonin to Prevent Brain Injury in Unborn Growth Restricted Babies

NCT ID: NCT01695070

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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Fetal Growth Retardation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

4mg prolonged release melatonin oral tablets twice daily

Interventions

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Melatonin

4mg prolonged release melatonin oral tablets twice daily

Intervention Type DRUG

Other Intervention Names

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Circadin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Monash University

OTHER

Sponsor Role lead

Responsible Party

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Nicole Alers

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicole O Alers, MD

Role: PRINCIPAL_INVESTIGATOR

The Ritchie Centre, Monash Institute of Medical Research, Monash University

Euan M Wallace, MBChB MD FRCOG FRANZCOG

Role: PRINCIPAL_INVESTIGATOR

Southern Health, The Ritchie Centre, Monash Institute of Medical Research, Monash University

Graham Jenkin, BSc PhD

Role: PRINCIPAL_INVESTIGATOR

The Ritchie Centre, Monash Institute of Medical Research

Suzanne L Miller, BSc PhD

Role: PRINCIPAL_INVESTIGATOR

The Ritchie Centre, Monash Institute of Medical Research

Locations

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Southern Health: Monash Medical Centre and Jessie McPherson Private Hospital

Clayton, Victoria, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 24456220 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24366583 (View on PubMed)

Other Identifiers

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ACTRN12612000858897

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1133-4541

Identifier Type: -

Identifier Source: org_study_id