Nightly Suppression of Contractions in At-Risk Pregnancies by the Infusion of Defused Blue Light
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of contractions per hour
研究概览
简要总结
The objective in the current study is to test the hypothesis that nocturnal uterine contractions in preterm women can be suppressed by brief ocular exposure to blue light.The Olcese lab at Florida State University identified a novel interaction between the myometrial melatonin receptors and OT receptors in human myometrial cells (Sharkey et al. 2009), which may ultimately help to resolve certain issues surrounding idiopathic preterm labor. Their results consistently indicate that melatonin at physiological concentration sensitizes human myometrial smooth muscle cells to the contractile effects of OT (Sharkey et al. 2010).
详细描述
Study participants will be pregnant women (gestational weeks 24 to 31+6 days) who present with preterm contractions. In the triage room, the study participant will be connected to the external tocometer from at least 19:00h (7 PM) to the following morning at 07:00h. Room lighting will be kept dim.
Participants meeting inclusion criteria will be randomly allocated to blue light or red light. Baseline contractions will be measured. The allocated light mask will be applied for 2 intervals of 60 minutes each.There will be a 60 minute rest period after every 60 minute intervention period for comparison.
Other than the application of the light mask, all routine standards of care deemed warranted by the obstetric provider for proper treatment of preterm labor will be followed. (ie antenatal steroids, tocolytics).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study group assignments will be placed in an opaque envelope which will be kept in the designated research area on Labor and Delivery. After informed consent is obtained, the coordinator will take one of the envelopes to determine the study group. The coordinator will not communicate with the care provide or the investigator regarding study group assignment.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age: 24 to 31 (+6 days) week of pregnancy
- •Uterine contractions
- •First episode of preterm labor
排除标准
- •Visual impairment (legally blind)
- •Multiple pregnancy
- •Current progesterone treatment
- •Preeclampsia
- •Renal disease
- •Current chlamydia or gonorrhea infections
- •Cocaine or opiate use
- •Nightshift work in the past week
研究组 & 干预措施
Experimental
Ocular light will be applied via a mask. The participants allocated to the experimental group will receive blue light
干预措施: Ocular light (Device)
Control
Ocular light will be applied via a mask. The participants allocated to the control group will receive red light
干预措施: Ocular light (Device)
结局指标
主要结局
Number of contractions per hour
时间窗: Immediately upon completion of intervention
Number of contractions per hour
次要结局
- Binary proportion of 4 or less compared to 5+ contractions per hour(Immediately upon completion of intervention)