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临床试验/NCT03581214
NCT03581214已完成不适用

Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 910 人开始时间: 2018年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
910
试验地点
2
主要终点
Umbilical Artery Malondialdehyde

研究概览

简要总结

Approximately 2/3 of laboring women receive supplemental oxygen (O2) in an attempt to reverse perceived fetal hypoxia on electronic fetal monitoring (EFM). O2 supplementation is most commonly used in patients with Category II EFM, a class of EFM patterns designed in part to identify fetal acidemia. This liberal use of O2 in laboring patients is concerning because hyperoxygenation in infants is associated with adverse outcomes including retinopathy and abnormal neurodevelopment. Furthermore, excess O2 exposure is linked to free radical generation and subsequent oxidative cell damage. This calls for a closer look at the safety of intrauterine O2 exposure. The proposed project explores potential mechanisms for harm with maternal O2 supplementation in laboring patients with Category II EFM. Specifically, this project will determine the effect of O2, compared to room air (RA), on umbilical cord and maternal levels of malondialdehyde (MDA) and 4-hydroxynonenal (4-HNE), markers of free radical-induced oxidative stress. The study will also explore the correlation between urinary and blood markers of oxidative stress. Banked specimens will be used to investigate the potential effect of peripartum O2 exposure on placental oxidative stress in the future.

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
Double (Investigator, Outcomes Assessor)

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

  • Singleton
  • Gestational age ≥37 weeks
  • Spontaneous labor or induction of labor
  • English speaking
  • Ability to give informed consent

排除标准

  • Major fetal anomaly
  • Multiple gestation
  • Category III electronic fetal monitoring
  • Maternal hypoxia
  • Preeclampsia
  • Intrauterine growth restriction
  • Pregestational diabetes
  • Tobacco use

结局指标

主要结局

Umbilical Artery Malondialdehyde

时间窗: At delivery

Umbilical Artery 4-hydroxynonenal

时间窗: At delivery

Maternal Malondialdehyde

时间窗: Within 1 hour of delivery

Maternal 4-hydroxynonenal

时间窗: Within 1 hour of delivery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nandini Raghuraman

Assistant Professor

Washington University School of Medicine

研究点 (2)

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