Maternal Oxygen Supplementation for Intrauterine Resuscitation: a Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,252
- 试验地点
- 1
- 主要终点
- Percentage of neonates meeting criteria for composite neonatal morbidity
研究概览
简要总结
More than 80% of the 3 million women who labor and deliver each year in the United States undergo continuous electronic fetal monitoring (EFM) during labor in order to fetal hypoxia and prevent the transition to acidemia, expedited operative delivery, and/or neonatal morbidity. Category II EFM is the most commonly observed group of fetal heart rate features in labor. One common response to Category II EFM is maternal oxygen (O2) supplementation. The theoretic rationale for O2 administration is that it increases O2 transfer to a hypoxic fetus. There are conflicting national guidelines regarding O2 administration - the American College of Obstetricians and Gynecologists suggest O2 is ineffective, whereas the Association of Women's Health, Obstetric, and Neonatal Nurses recommend continued use given lack of definitive data on safety and efficacy. A recent national survey of nearly 600 Labor & Delivery providers in February 2022 revealed that 49% still use O2 . Thus, there remains equipoise on the topic and high-quality data on the safety of intrapartum O2 is needed. None of the trials to date have studied the effect of intrapartum O2 on important clinical measures of neonatal or maternal morbidity. This safety data is imperative because the field of obstetrics must hold supplemental O2 to the same rigorous standards applied to any drug used in pregnancy. Without data on these definitive outcomes, it will be challenging to implement evidence-based recommendations for supplemental O2 use on Labor & Delivery. The investigators will conduct a large, multicenter, randomized noninferiority trial of O2 supplementation versus room air in patients with Category II EFM in labor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton gestation
- •Gestational age>=37 weeks
- •Spontaneous labor or induction of labor
- •English or spanish speaking
- •Planned continuous fetal monitoring
排除标准
- •Preterm gestation
- •Major fetal anomaly
- •Multiple gestation
- •Category III fetal monitoring at time of admission
- •Maternal hypoxia <95%
- •Planned or scheduled cesarean delivery Excluded from randomization if receiving nitrous oxide for analgesia at time of randomization.
研究组 & 干预措施
Oxygen
干预措施: Maternal oxygen supplementation (Other)
Room air
干预措施: Room air (Other)
结局指标
主要结局
Percentage of neonates meeting criteria for composite neonatal morbidity
时间窗: Up to 28 days of life
One of the following diagnoses: Neonatal death, acidemia, meconium aspiration with pulmonary hypertension, hypoglycemia, hypoxic ischemic encephalopathy ,hypothermia treatment, seizure, respiratory distress
次要结局
- Percentage of neonates with seizure(28 days of life)
- Percentage of neonates with respiratory distress(Within 72 hours of delivery)
- Percentage of patients with composite maternal morbidity(Within 2 weeks of delivery)
- Percentage of patients with operative delivery for the indication of nonreassuring fetal status(At delivery)
- Percentage of neonates with acidemia (pH<7.1)(At time of delivery)
- Percentage of neonates with meconium aspiration with pulmonary hypertension(Within 72 hours of delivery)
- Percentage of neonates with Neonatal Intensive care unit admission(Within 72 hours of delivery)
- Perentage of patients with operative delivery (cesarean or operative vaginal delivery)(At delivery)
- Percentage of neonates with neonatal death(28 days of life)
- umbilical artery base excess(At delivery)
- Apgars at 5 and 10 minutes(At 5 and 10 minutes of neonatal life)
- Percentage of neonates with hypoxic ischemic encephalopathy(Within 72 hours of delivery)
- Percentage of neonates with hypothermia treatment(Within 72 hours of delivery)
- umbilical artery partial pressure carbon dioxide(At delivery)
- Percentage of neonates with hypoglycemia(Within 24 hours of delivery)
- umbilical artery partial pressure oxygen(At delivery)
- Apgar<5 at 5 and 10 mins(At 5 and 10 minutes of neonatal life)
