Testing Effects of Melatonin on Uterine Contractions in Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Daytime: Total number of uterine contractions
研究概览
简要总结
The study will extend recent discoveries that have been made in basic human physiology related to responses melatonin and uterine contractions in late- or full-term pregnant women. The basic physiology work has been conducted in in vitro models of the human myometrium characterizing its responses to melatonin, and in pilot in vivo studies correlating the number of uterine contractions with melatonin concentrations that were manipulated by different types of light exposure. The planned experiments will test a causal link between circulating melatonin levels and uterine contractions in full-term pregnant women by manipulating melatonin levels using exogenous melatonin (i) during the day when endogenous levels of melatonin are very low (Experiment 1), and (ii) during the evening under conditions with lighting that would be expected to suppress the higher evening and nighttime levels of endogenous melatonin (Experiment 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •nulliparity, age between 18 and 35,
- •BMI<36 pre-pregnancy,
- •≥38 weeks of pregnancy with a single fetus at time of study.
排除标准
- •color blind;
- •prescription drugs affecting sleep, melatonin, and/or circadian rhythms (e.g., beta blockers, non-steroidal anti-inflammatory drugs);
- •a health or pregnancy related condition that might affect melatonin or uterine contractions;
- •medical conditions or medications for which melatonin might be contraindicated or there may be a drug interactions (e.g., Central Nervous System depressants/sedatives, Fluvoxamin (Luvox), medications for diabetes, immunosuppressants, anti-coagulants, Nifedipine, Verapamil).
- •Note: We cannot list all possible exclusionary criteria. Dr. Carolina Bibbo (co-I), our Obstetrics Investigator at Brigham and Women's Hospital (BWH), will make final determination of suitability including any safety concerns for each potential participant.
研究组 & 干预措施
Daytime melatonin 0.0 mg
Daytime melatonin 0.0 mg
干预措施: Placebo (Dietary Supplement)
Nighttime melatonin 0.0 mg
Nighttime melatonin 0.0 mg
干预措施: Placebo (Dietary Supplement)
Daytime melatonin 0.5 mg
Daytime melatonin 0.5 mg
干预措施: Melatonin (Dietary Supplement)
Daytime melatonin 3.0 mg
Daytime melatonin 3.0 mg
干预措施: Melatonin (Dietary Supplement)
Nighttime melatonin 0.5 mg
Nighttime melatonin 0.5 mg
干预措施: Melatonin (Dietary Supplement)
结局指标
主要结局
Daytime: Total number of uterine contractions
时间窗: 10 hours
Daytime: Total number of uterine contractions
Nighttime: Total number of uterine contractions
时间窗: 4 hours
Nighttime: Total number of uterine contractions
次要结局
未报告次要终点
研究者
Elizabeth Klerman MD PhD
Professor
Brigham and Women's Hospital