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临床试验/NCT01863446
NCT01863446已完成不适用

Effects of Light on Melatonin and Contractions in Pregnant Women

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2013年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Melatonin Area Under the Curve (AUC)

研究概览

简要总结

Specific Aim: Test the hypothesis that ocular light exposure will suppress melatonin secretion and reduce uterine contractions in women at late term pregnancies.

Secondary aim. Test the hypothesis that ocular light exposure will reduce self-reported uterine contractions in women at late term pregnancies.

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
Single (Participant)

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

  • •pregnant at 35-40 weeks
  • •first pregnancy

排除标准

  • •pregnancy-related complications
  • •twin or higher pregnancy
  • •using medication that affects the sympathetic nervous system

研究组 & 干预措施

Lighting2

Experimental

Ocular light exposure of a blue-green wavelength light for one night

干预措施: Lighting2 (Device)

Lighting3

Experimental

Ocular light exposure to a red wavelength light on night 1 and to a red wavelength light on night 2

干预措施: Lighting1 (Device)

Lighting1

Experimental

Ocular light exposure of a red wavelength light for one night

干预措施: Lighting1 (Device)

Lighting4

Experimental

Ocular light exposure to a red wavelength light on night 1 and to a blue-green wavelength light on night 2

干预措施: Lighting1 (Device)

Lighting4

Experimental

Ocular light exposure to a red wavelength light on night 1 and to a blue-green wavelength light on night 2

干预措施: Lighting2 (Device)

结局指标

主要结局

Melatonin Area Under the Curve (AUC)

时间窗: 4 hours of light exposure.

Melatonin will be assessed using concentrations in saliva or blood. AUC will be calculated using melatonin concentrations during the Outcome Measure Time Frame. (1) for Lighting1 and Lighting2, the AUC for night 1; (2) for Lighting3 and Lighting4, the AUC for Night 2

次要结局

  • Uterine Contractions(4 hours of light exposure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Klerman MD PhD

Associate Professor

Brigham and Women's Hospital

研究点 (1)

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