Effect of Maternal and Neonatal Oxygenation
Effects of Neonate and Maternal Oxygenation in Low-dose Oxygen Supplement by Oxygen Cannula or Non- Supplement in Elective Cesarean Section: a Randomized Controlled Trial
Intraoperative supplemental oxygen has been given for most parturients undergoing cesarean section under spinal anesthesia. However, evidences supporting the practice is not clear nowadays, especially for healthy parturients who are monitored continuously with pulse oximeter. Furthermore, hyperoxia may produce free radicles which could harm fetus and newborns.
Changing practice is not that easy. This study has been conducted to prove that supplemental oxygen is not necessary for healthy parturients during cesarean section.
研究概览
详细说明
Supplemental oxygen has been routinely given to parturients because doctors were concerned about desaturation. However, the evidences for giving oxygen was not strong, and the condition nowadays can be detected immediately with pulse oximeter which is a standard monitoring.
After this study finished, we will set a safety guideline for supplemental oxygen for healthy parturients undergoing elective cesarean section.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
-
-
-
Bangkok、泰国、10700
- Siriraj Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged > 18 years old.
- Term pregnancy (gestational age 37 -42 weeks).
- Singleton
- Elective cesarean section.
Exclusion Criteria:
- History of infertility
- Diabetes
- Hypertension or preeclampsia
- Heart disease
- Morbid obesity
- Premature rupture of membrane
- Placenta previa
- Preoperative oxygen saturation < 95%
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：room air
no supplemental oxygen in intraoperative period
|
|
|
实验性的：Oxygen
Supplemental 3LPM oxygen via canula
|
Parturients will receive supplemental oxygen (3LPM) via nasal canula
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
proportion of maternal desaturation
大体时间：intraoperative period
|
Oxygen saturation < 94% once.
|
intraoperative period
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
neonatal outcomes
大体时间：intraoperative period
|
Apgar score and parameters from umbilical cord gas
|
intraoperative period
|
合作者和调查者
调查人员
- 首席研究员：Arunotai Siriussawakul, MD.、Mahidol University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 10AS00008/044/10
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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