Melatonin to prevent brain injury in unborn growth restricted babies

A pilot study of maternally administered melatonin to decrease the level of oxidative stress in human pregnancies affected by intrauterine growth restriction.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000858897

Acronym

MEL trial

Enrollment

Registered

2012-08-14

Start date

2012-09-07

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

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

Outcome results