跳至主要内容
临床试验/NCT04081584
NCT04081584终止不适用

Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering

Raydiant Oximetry, Inc.1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
1
主要终点
Optical signal from maternal and fetal tissues

研究概览

简要总结

This study is being conducted to study light scattering properties of maternal-fetal tissue.

详细描述

The ISS customized commercial frequency domain oximeter is used to obtain light scattering information from the maternal abdomen for 10-20 minutes preoperatively and postoperatively in subjects who are having a scheduled C-section.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women with singleton pregnancies, vertex or breech presentation, scheduled for non-emergent cesarean delivery, including cesarean delivery for failure to progress with reassuring electronic fetal heart rate tracing
  • Age greater than or equal to 18 years of age.
  • Healthy women at equal to or greater than 36 weeks gestation undergoing non-emergency cesarean delivery
  • Spinal or epidural anesthesia

排除标准

  • Emergency cesarian delivery
  • Non-reassuring fetal heart rate tracing
  • Less than 18 years of age
  • Multiple gestation (twins, triplets)
  • Presentation other than vertex or breech
  • Less than 36 weeks of gestation
  • General anesthesia

结局指标

主要结局

Optical signal from maternal and fetal tissues

时间窗: Peri-operative

The study of light scattering through maternal/fetal tissue and through maternal tissue alone and newborn tissue alone using a commercial frequency domain oximeter and 2nd generation prototype.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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