Prophylactic Maternal Low Flow Nasal Oxygen Administration During the Second Stage of Labor for Fetal Distress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 443
- 试验地点
- 3
- 主要终点
- cord arterial pH values (hydrogen ion concentration) less than 7.2
研究概览
简要总结
Supplementary oxygen is routinely administered to patients, even those with adequate oxygen saturations, in the belief that it increases oxygen delivery. However, oxygen delivery depends not just on arterial oxygen content but also on perfusion.
Maternal oxygen administration has been used in an attempt to lessen fetal distress by increasing the available oxygen from the mother. However, the effect of supplemental maternal oxygen therapy on fetal acid base status has been debated for more than seven decades.
Hypothesis: Prophylactic maternal low flow nasal oxygen administration during the second stage of labor can relieve fetal distress.
详细描述
A report from the cochran library (Cochrane Database Syst Rev. 2012 Dec 12;12:CD000136.):
Too little evidence to show whether oxygen administration to the woman during labour is beneficial to the baby.
Some babies show signs of distress, such as unusual heart rates or the passing of a bowel motion (meconium) during their mother's labour. This may be caused by a lack of oxygen passing from the woman to the baby through the placenta. Sometimes, women may be encouraged to breathe extra oxygen through a facemask (oxygen administration) to increase the oxygen available to the unborn baby. A review of two trials found too little evidence to show whether oxygen administration to the woman during the second stage of labour is beneficial to the baby. No trials of oxygen administration when the baby is showing signs of distress were found. Further research is needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton
- •primigraida
- •cephalic presentation
- •spontaneous or induced labor
- •normal labor
- •normal FHR tracings in the first stage
- •at the onset of second stage
排除标准
- •respiratory disease
- •cardiovascular disease
- •diabetes mellitus or insulin-treated gestational diabetes mellitus
- •hypertension or preeclampsia
- •oligohydramnios
- •fetal growth restriction
- •placental abruption
- •disorders in oxygen saturations
- •received oxygen therapy in the first stage
结局指标
主要结局
cord arterial pH values (hydrogen ion concentration) less than 7.2
时间窗: within 30-60 seconds of birth
Immediately after delivery (within 30-60 seconds of birth), umbilical cord arterial blood gas sample will be obtained.
次要结局
- Apgar score less than 7(at one and five minutes after birth)
- maternal radial arterial partial pressure of oxygen(within 30-60 seconds of birth)
- umbilical cord venous partial pressure of oxygen(within 30-60 seconds of birth)
研究者
Yunhai Chuai
Department of Obstetrics and Gynecology, Navy General Hospital, Beijing
Navy General Hospital, Beijing