Melatonin to Prevent Brain Injury in Unborn Growth Restricted Babies
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ClinicalTrials.gov Identifier: NCT01695070 |
Recruitment Status :
Completed
First Posted : September 27, 2012
Last Update Posted : November 18, 2014
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Condition or disease | Intervention/treatment | Phase |
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Fetal Growth Retardation | Drug: Melatonin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | September 2012 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | November 2014 |

Arm | Intervention/treatment |
---|---|
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.
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Drug: Melatonin
4mg prolonged release melatonin oral tablets twice daily
Other Name: Circadin |
- 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).
- 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).
- 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.
- 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)
- Gestational age at birth. [ Time Frame: Once, at birth. ]Gestational age at birth will be calculated using the last menstrual period and ultrasound characteristics.
- 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.

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695070
Australia, Victoria | |
Southern Health: Monash Medical Centre and Jessie McPherson Private Hospital | |
Clayton, Victoria, Australia, 3168 |
Principal Investigator: | Nicole O Alers, MD | The Ritchie Centre, Monash Institute of Medical Research, Monash University | |
Principal Investigator: | Euan M Wallace, MBChB MD FRCOG FRANZCOG | Southern Health, The Ritchie Centre, Monash Institute of Medical Research, Monash University | |
Principal Investigator: | Graham Jenkin, BSc PhD | The Ritchie Centre, Monash Institute of Medical Research | |
Principal Investigator: | Suzanne L Miller, BSc PhD | The Ritchie Centre, Monash Institute of Medical Research |
Responsible Party: | Nicole Alers, MD, Monash University |
ClinicalTrials.gov Identifier: | NCT01695070 |
Other Study ID Numbers: |
U1111-1133-4541 ACTRN12612000858897 ( Registry Identifier: Australian New Zealand Clinical Trial Registry ) |
First Posted: | September 27, 2012 Key Record Dates |
Last Update Posted: | November 18, 2014 |
Last Verified: | November 2014 |
Fetal Growth Retardation Fetal Diseases Pregnancy Complications Growth Disorders Pathologic Processes Melatonin |
Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Central Nervous System Depressants |