Antenatal melatonin as an antioxidant in human pregnancies complicated by fetal growth restriction--a phase I pilot clinical trial: study protocol

Research output: Contribution to journalArticleOther

36 Citations (Scopus)

Abstract

BACKGROUND: Fetal growth restriction complicates about 5 of pregnancies and is commonly caused by placental dysfunction. It is associated with increased risks of perinatal mortality and short-term and long-term morbidity, such as cerebral palsy. Chronic in utero hypoxaemia, inflammation and oxidative stress are likely culprits contributing to the long-term neurological sequelae of fetal growth restriction. In this regard, we propose that melatonin, a powerful antioxidant, might mitigate morbidity and/or mortality associated with fetal growth restriction. Melatonin has an excellent biosafety profile and crosses the placenta and blood-brain barrier. We present the protocol for a phase I clinical trial to investigate the efficacy of maternal oral melatonin administration in women with a pregnancy complicated by fetal growth restriction. METHODS AND ANALYSIS: The proposed trial is a single-arm, open-label clinical trial involving 12 women. Severe, early onset fetal growth restriction will be diagnosed by an estimated fetal weight
Original languageEnglish
Pages (from-to)1 - 6
Number of pages6
JournalBMJ Open
Volume3
Issue number12
DOIs
Publication statusPublished - 2013

Cite this

@article{8f984b8a51ae4838aec979437814738f,
title = "Antenatal melatonin as an antioxidant in human pregnancies complicated by fetal growth restriction--a phase I pilot clinical trial: study protocol",
abstract = "BACKGROUND: Fetal growth restriction complicates about 5 of pregnancies and is commonly caused by placental dysfunction. It is associated with increased risks of perinatal mortality and short-term and long-term morbidity, such as cerebral palsy. Chronic in utero hypoxaemia, inflammation and oxidative stress are likely culprits contributing to the long-term neurological sequelae of fetal growth restriction. In this regard, we propose that melatonin, a powerful antioxidant, might mitigate morbidity and/or mortality associated with fetal growth restriction. Melatonin has an excellent biosafety profile and crosses the placenta and blood-brain barrier. We present the protocol for a phase I clinical trial to investigate the efficacy of maternal oral melatonin administration in women with a pregnancy complicated by fetal growth restriction. METHODS AND ANALYSIS: The proposed trial is a single-arm, open-label clinical trial involving 12 women. Severe, early onset fetal growth restriction will be diagnosed by an estimated fetal weight",
author = "Alers, {Nicole Odile} and Graham Jenkin and Miller, {Suzanne Lee} and Wallace, {Euan Morrison}",
year = "2013",
doi = "10.1136/bmjopen-2013- 004141",
language = "English",
volume = "3",
pages = "1 -- 6",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "12",

}

TY - JOUR

T1 - Antenatal melatonin as an antioxidant in human pregnancies complicated by fetal growth restriction--a phase I pilot clinical trial: study protocol

AU - Alers, Nicole Odile

AU - Jenkin, Graham

AU - Miller, Suzanne Lee

AU - Wallace, Euan Morrison

PY - 2013

Y1 - 2013

N2 - BACKGROUND: Fetal growth restriction complicates about 5 of pregnancies and is commonly caused by placental dysfunction. It is associated with increased risks of perinatal mortality and short-term and long-term morbidity, such as cerebral palsy. Chronic in utero hypoxaemia, inflammation and oxidative stress are likely culprits contributing to the long-term neurological sequelae of fetal growth restriction. In this regard, we propose that melatonin, a powerful antioxidant, might mitigate morbidity and/or mortality associated with fetal growth restriction. Melatonin has an excellent biosafety profile and crosses the placenta and blood-brain barrier. We present the protocol for a phase I clinical trial to investigate the efficacy of maternal oral melatonin administration in women with a pregnancy complicated by fetal growth restriction. METHODS AND ANALYSIS: The proposed trial is a single-arm, open-label clinical trial involving 12 women. Severe, early onset fetal growth restriction will be diagnosed by an estimated fetal weight

AB - BACKGROUND: Fetal growth restriction complicates about 5 of pregnancies and is commonly caused by placental dysfunction. It is associated with increased risks of perinatal mortality and short-term and long-term morbidity, such as cerebral palsy. Chronic in utero hypoxaemia, inflammation and oxidative stress are likely culprits contributing to the long-term neurological sequelae of fetal growth restriction. In this regard, we propose that melatonin, a powerful antioxidant, might mitigate morbidity and/or mortality associated with fetal growth restriction. Melatonin has an excellent biosafety profile and crosses the placenta and blood-brain barrier. We present the protocol for a phase I clinical trial to investigate the efficacy of maternal oral melatonin administration in women with a pregnancy complicated by fetal growth restriction. METHODS AND ANALYSIS: The proposed trial is a single-arm, open-label clinical trial involving 12 women. Severe, early onset fetal growth restriction will be diagnosed by an estimated fetal weight

UR - http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3884842/pdf/bmjopen-2013-004141.pdf

U2 - 10.1136/bmjopen-2013- 004141

DO - 10.1136/bmjopen-2013- 004141

M3 - Article

VL - 3

SP - 1

EP - 6

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 12

ER -