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临床试验/NCT03764696
NCT03764696已完成不适用

The Effect of Maternal Long Term High Flow Oxygen Administration During Labor on Umbilical Cord Blood Gases

Navy General Hospital, Beijing3 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
3
主要终点
Cord arterial partial pressure of oxygen

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.

The investigators found the use of 2 L/min maternal oxygen during the second stage of labor did not adversely affect either the umbilical artery pH value or the fetal heart rate (FHR) pattern distribution.

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
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • at term (>37 weeks, <42 weeks), singleton, cephalic presentation, spontaneous or induced labor, normal labor, category I FHR tracings, 2 to 3 cm of cervical dilation in nulliparity, 1 to 2 cm of cervical dilation in multipara, informed consent.

排除标准

  • respiratory or cardiovascular disease, diabetes mellitus or insulin-treated gestational diabetes mellitus, hypertension or preeclampsia, oligohydramnios, fetal growth restriction, placental abruption, cephalopelvic disproportion, meconium-stained amniotic fluid, tachysystole, having received O2, uterine incision (myomectomy or perforation), anemia, fever, chorioamnionitis, tobacco or alcohol use, disorders in oxygen saturations, hypotension, uncomfortable with facemask.

结局指标

主要结局

Cord arterial partial pressure of oxygen

时间窗: within 30 to 60 seconds of birth

Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.

Cord arterial pH values

时间窗: within 30 to 60 seconds of birth

Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.

Cord venous partial pressure of carbon dioxide

时间窗: within 30 to 60 seconds of birth

Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.

Cord venous pH values

时间窗: within 30 to 60 seconds of birth

Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.

Cord arterial partial pressure of carbon dioxide

时间窗: within 30 to 60 seconds of birth

Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.

Cord venous partial pressure of oxygen

时间窗: within 30 to 60 seconds of birth

Immediately after delivery (within 30-60 seconds of birth), blood gas sample will be obtained.

次要结局

  • Rate of abnormal fetal heart tracing(at 1 minute after birth)

研究者

发起方
Navy General Hospital, Beijing
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yunhai Chuai

Clinical Professor of Obstetrics and Gynecology, Principal Investigator

Navy General Hospital, Beijing

研究点 (3)

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