Clinical trial NCT01695070: Melatonin to Prevent Brain Injury in Unborn Growth Restricted Babies
Official title: A Pilot Study of Maternally Administered Melatonin to Decrease the Level of Oxidative Stress in Human Pregnancies Affected by Intrauterine Growth Restriction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fetal Growth Retardation
Lead sponsor: Monash University
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Oxidative stress in the umbilical artery
timeFrame: Once, at birth.
Secondary outcomes:
measure: Oxidative stress in maternal venous serum
timeFrame: Once within one week before start treatment and once per week during the treatment period (estimated to be an average of 4 weeks).
measure: Fetoplacental Doppler studies
timeFrame: Once within one week before start treatment and twice per week during the treatment period (estimated to be an average of 4 weeks).
measure: Placental oxidative stress
timeFrame: Once, at birth.
measure: Gestational age at birth.
timeFrame: Once, at birth.
measure: Composite neonatal outcome.
timeFrame: Participants will be followed for the duration of hospital stay, up to 12 months.
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: Southern Health: Monash Medical Centre and Jessie McPherson Private Hospital
state: Victoria
Study officials:
affiliation: The Ritchie Centre, Monash Institute of Medical Research, Monash University
name: Nicole O Alers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Health, The Ritchie Centre, Monash Institute of Medical Research, Monash University
name: Euan M Wallace, MBChB MD FRCOG FRANZCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: The Ritchie Centre, Monash Institute of Medical Research
name: Graham Jenkin, BSc PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Ritchie Centre, Monash Institute of Medical Research
name: Suzanne L Miller, BSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.