A Pilot Study of Maternally Administered Melatonin to Decrease the Level of Oxidative Stress in Human Pregnancies Affected by Intrauterine Growth Restriction.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Oxidative stress in the umbilical artery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Fetal demise.
- •Multiple pregnancy.
- •Known abnormal karyotype.
- •Presence of any congenital abnormality.
- •Unknown duration of pregnancy.
- •IUGR attributable to non-placental factors.
研究组 & 干预措施
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.
干预措施: Melatonin (Drug)
结局指标
主要结局
Oxidative stress in the umbilical artery
时间窗: 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).
次要结局
- Oxidative stress in maternal venous serum(Once within one week before start treatment and once per week during the treatment period (estimated to be an average of 4 weeks).)
- Fetoplacental Doppler studies(Once within one week before start treatment and twice per week during the treatment period (estimated to be an average of 4 weeks).)
- Composite neonatal outcome.(Participants will be followed for the duration of hospital stay, up to 12 months.)
- Placental oxidative stress(Once, at birth.)
- Gestational age at birth.(Once, at birth.)