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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 1
- 主要终点
- proportion of maternal desaturation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged > 18 years old.
- •Term pregnancy (gestational age 37 -42 weeks).
- •Singleton
- •Elective cesarean section.
排除标准
- •History of infertility
- •Hypertension or preeclampsia
- •Heart disease
- •Morbid obesity
- •Premature rupture of membrane
- •Placenta previa
- •Preoperative oxygen saturation < 95%
研究组 & 干预措施
Oxygen
Supplemental 3LPM oxygen via canula
干预措施: Supplemental 3LPM oxygen via canula (Drug)
结局指标
主要结局
proportion of maternal desaturation
时间窗: intraoperative period
Oxygen saturation \< 94% once.
次要结局
- neonatal outcomes(intraoperative period)