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Completed

NCT Number: NCT01695070

Melatonin to Prevent Brain Injury in Unborn Growth Restricted Babies

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.

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Key information

Conditions

Fetal Growth Retardation Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Southern Health: Monash Medical Centre and Jessie McPherson Private Hospital

Clayton, Victoria, 3168, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Melatonin

Drug

4mg prolonged release melatonin oral tablets twice daily

Other names: Circadin

Primary outcomes

  1. Oxidative stress in the umbilical artery

    Time frame: Once, at birth.

    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).

Secondary outcomes

  1. Oxidative stress in maternal venous serum

    Time frame: Once within one week before start treatment and once per week during the treatment period (estimated to be an average of 4 weeks).

    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).

  2. Fetoplacental Doppler studies

    Time frame: Once within one week before start treatment and twice per week during the treatment period (estimated to be an average of 4 weeks).

    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.

  3. Placental oxidative stress

    Time frame: Once, at birth.

    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)

  4. Gestational age at birth.

    Time frame: Once, at birth.

    Gestational age at birth will be calculated using the last menstrual period and ultrasound characteristics.

  5. Composite neonatal outcome.

    Time frame: Participants will be followed for the duration of hospital stay, up to 12 months.

    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.

Sponsors and collaborators

Lead sponsor

Monash University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 27, 2012
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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