Melatonin to Prevent Brain Injury in Unborn Growth Restricted Babies

Fetal Growth Retardation Clinical Trial

Official title:

A Pilot Study of Maternally Administered Melatonin to Decrease the Level of Oxidative Stress in Human Pregnancies Affected by Intrauterine Growth Restriction.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695070
• Other study ID #: U1111-1133-4541
• Secondary ID: ACTRN12612000858
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2012
• Last updated: November 14, 2014
• Start date: September 2012
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Growth Retardation

Intervention

Drug:
• Melatonin
4mg prolonged release melatonin oral tablets twice daily

Locations

Country	Name	City	State
Australia	Southern Health: Monash Medical Centre and Jessie McPherson Private Hospital	Clayton	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Monash University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative stress in the umbilical artery	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).	Once, at birth.	No
Secondary	Oxidative stress in maternal venous serum	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).	Once within one week before start treatment and once per week during the treatment period (estimated to be an average of 4 weeks).	No
Secondary	Fetoplacental Doppler studies	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.	Once within one week before start treatment and twice per week during the treatment period (estimated to be an average of 4 weeks).	No
Secondary	Placental oxidative stress	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)	Once, at birth.	No
Secondary	Gestational age at birth.	Gestational age at birth will be calculated using the last menstrual period and ultrasound characteristics.	Once, at birth.	No
Secondary	Composite neonatal outcome.	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.	Participants will be followed for the duration of hospital stay, up to 12 months.	No