Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate
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
- 是
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
Nandini Raghuraman
Assistant Professor
Washington University School of Medicine
