Circulating Melatonin and 6-hydroxymelatonin Levels During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in melatonin and 6-hydroxymelatonin levels during pregnancy
研究概览
简要总结
Melatonin is well known for its role in the sleep-wake cycle but it is less well known as an effective antioxidant. It has been reported to be synthesised in the placenta and may have both receptor mediated and non-receptor mediated protective functions during pregnancy. Severe pre-eclampsia has been reported to be associated with low levels of melatonin in the placenta although it is not known if the placental melatonin contributes to circulating levels. There is little reported on the circulating levels of melatonin or oxidative stress at different stages of normal pregnancy. More information on the role of melatonin and metabolism of melatonin in pregnancy as well as any significant association with adverse pregnancy outcomes would inform planning of larger research studies to investigate the potential role for melatonin as a biomarker for obstetric disease and potentially as a therapeutic agent in future.
This observational pilot study aims to measure serum melatonin levels and 6-hydroxymelatonin sulphate (the major metabolite of melatonin) during each trimester of pregnancy.
详细描述
Melatonin, a substance produced by the pineal gland, is well known for its role in the sleep-wake cycle but it is less well known as an effective antioxidant. It is able to access all parts of the cell, and can cross the blood-brain and placental barrier. Melatonin has been reported to be synthesised in the placenta and may have both receptor mediated and non-receptor mediated protective functions during pregnancy. Severe pre-eclampsia has been reported to be associated with low levels of melatonin in the placenta although it is not known if the placental melatonin contributes to circulating levels. Despite this, melatonin levels have been proposed as a biomarker of pre-eclampsia. A further study suggested pregnant women with hypertensive or diabetic conditions had lower melatonin levels and less circadian variation, again suggesting the potential protective role melatonin may have during pregnancy. Due to its antioxidant effects melatonin has also been proposed as a protective substance for women undergoing assisted reproduction techniques.
Rationale for study There is little reported on the circulating levels of melatonin or oxidative stress at different stages of normal pregnancy. More information on the role of melatonin and metabolism of melatonin in pregnancy as well as any significant association with adverse pregnancy outcomes would inform planning of larger research studies to investigate the potential role for melatonin as a bio-marker for obstetric disease and potentially as a therapeutic agent in future.
This observational pilot study aims to measure serum melatonin levels and 6-hydroxymelatonin sulphate (the major metabolite of melatonin) during each trimester of pregnancy.
STUDY OBJECTIVES Objectives Primary Objective To determine if serum melatonin and 6-hydroxymelatonin sulphate levels differ in each trimester of pregnancy and how these compare to non-pregnant women Secondary Objectives
- To determine level of oxidative stress at time of serum sample by measuring lipid peroxide levels
- To explore whether levels of serum melatonin and 6-hydroxymelatonin sulphate vary in women who develop antenatal complications (pre-eclampsia or hypertensive diseases of pregnancy, preterm labour or gestational diabetes)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant subjects
- •Primigravid women (in their first pregnancy)
- •Singleton pregnancy
- •Aged 16-45
- •Taking no regular medication other than pregnancy related vitamins or supplements
- •First trimester (FVS) ultrasound scan reported as normal
- •Non pregnant subjects
- •Non pregnant women
- •Aged 16-45
- •No chronic health issues and not taking any medication
排除标准
- •Pregnant subjects
- •Pregnancy non-viable on scan
- •Twins or higher multiple pregnancies
- •Outside age range
- •Diabetes or pre-existing hypertension, chronic kidney disease or known autoimmune disorder
- •Non pregnant subjects
- •Outside age range
- •Chronic health complaint/taking medication
- •Recent blood donation over 1 unit
结局指标
主要结局
Change in melatonin and 6-hydroxymelatonin levels during pregnancy
时间窗: Values up to 40 weeks
Do serum melatonin and 6-hydroxymelatonin sulphate levels differ in each trimester of pregnancy? Levels during each trimester will be compared.
次要结局
- Change in lipid peroxide levels during pregnancy(Values up to 40 weeks)
- Relationship between melatonin and 6-hydroxymelatonin levels and duration of pregnancy.(Up to 40 weeks)
- Relationship between melatonin and 6-hydroxymelatonin levels and pre-eclampsia(Up to 40 weeks)
- Relationship between melatonin and 6-hydroxymelatonin levels with different types of delivery.(Up to 40 weeks)
- Relationship between melatonin and 6-hydroxymelatonin levels and gestational diabetes(Up to 40 weeks)
- Melatonin and 6-hydroxymelatonin levels in pregnancy compared to non pregnant(Up to 40 weeks)