Melatonin to Prevent Brain Injury in Unborn Growth Restricted Babies

Monash University

Status and phase: Completed; Phase 4

Conditions: Fetal Growth Retardation

Treatments: Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT01695070

U1111-1133-4541

ACTRN12612000858897 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Melatonin

Experimental group

Description:

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.

Treatment:

Drug: Melatonin