Uterine Contractions Under Blue Light
赞助:
University of South Florida
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | September 6, 2018 | ||
| 预计主要完成日期 | June 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Number of contractions per hour[ Time Frame: Immediately upon completion of intervention ] Number of contractions per hour |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Uterine Contractions Under Blue Light | ||
| 正式标题 ICMJE | Nightly Suppression of Contractions in At-Risk Pregnancies by the Infusion of Defused Blue Light | ||
| 简要概况 | 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). |
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| 详细说明 | 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). | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Randomized clinical trial 盲法: Interventional 盲法描述: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. 主要目的: Treatment |
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| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
30 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | June 2019 | ||
| 预计主要完成日期 | June 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Pregnant - Gestational age: 24 to 31 (+6 days) week of pregnancy - Uterine contractions - First episode of preterm labor Exclusion Criteria: - 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 | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：55 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | University of South Florida | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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