Maternal oxygen supplementation for Intrauterine Resuscitation: a Multicenter Randomized Trial

宫内复苏中母体氧气补充：一项多中心随机试验

基本信息

批准号：
10705573
负责人：
Nandini Raghuraman
金额：
$ 65.33万
依托单位：
WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-16 至 2027-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10705573
关键词：
Admission activity Adult Air American College of Obstetricians and Gynecologists Apgar Score Blood Categories Cervical Cesarean section Clinical Country Data Dose Effectiveness Electronics Exposure to Fetal Heart Rate Fetal Monitoring Fetus Future Gases Geography Goals Hospitals Hour Hypoglycemia Hypoxia Infant Inferior Intervention Knowledge Measures Meconium Aspiration Meta-Analysis Metabolic acidosis Monitor Morbidity - disease rate Mothers Neonatal Neonatal Intensive Care Units Neonatal Nursing Obstetrical Nursing Outcome Oxygen Oxygen Therapy Care Patients Pattern Pediatrics Protocols documentation Public Health Publishing Pulmonary Hypertension Randomized Recommendation Respiratory distress Resuscitation Retrospective cohort study Risk Seizures Structure of umbilical artery Supplementation Surrogate Markers Testing Time United States Vaginal delivery procedure Woman Women&apos s Health Work adverse outcome arm clinical application clinically relevant data management evidence base evidence based guidelines fetal fetus hypoxia improved in utero intrapartum maternal morbidity maternal outcome mortality natural hypothermia neonatal death neonatal hypoxic-ischemic brain injury neonatal morbidity neonatal outcome neonatal resuscitation neonate newborn wet lung disease pilot trial prevent randomized trial recruit response supplemental oxygen trial comparing

项目摘要

Abstract 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. The goal of such monitoring is to identify fetal hypoxia and prevent the transition to acidemia, expedited operative delivery, and/or neonatal morbidity. Category II EFM, the most commonly observed group of fetal heart rate features, is associated with variable risks for acidemia. 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, thereby reversing hypoxia and preventing acidemia. This practice is so commonly used that 2 out of 3 patients receive supplemental O2 at some point during labor. However, despite the theoretic rationale, there is no rigorous data to support its widespread use. Our pilot randomized noninferiority trial, published in JAMA Pediatrics, demonstrated that room air was noninferior to O2 for improving umbilical artery lactate, a surrogate marker of fetal acidemia and neonatal morbidity. Our subsequent meta-analysis of randomized trials investigating O2 versus room air at time of cesarean section or vaginal delivery found no differences in umbilical artery pH, rates of acidemia, and neonatal intensive care unit admissions between room air and O2 groups. Importantly, none of the trials studied important clinical measures of neonatal or maternal morbidity and only one trial studied O2 in the setting of Category II EFM. The current state of evidence is limited in several ways. First, the existing studies of O2 in labor vary in the dose, duration, and timing of O2 administration. Second, only one pilot trial investigated the utility of O2 supplementation for the ACOG-recommended indication of Category II EFM. Third, all of the studies have used surrogate measures of neonatal morbidity such as cord gases or neonatal intensive care unit admission. Finally, none of the studies were powered to assess the impact of O2 administration on neonatal clinical sequelae of in utero hypoxia or operative delivery. Without data on these definitive outcomes, evidence-based recommendations for managing Category II EFM cannot be made. To fill this important knowledge gap, we propose a large, multicenter, randomized noninferiority trial of O2 supplementation versus room air in patients with Category II EFM in labor. Our central hypothesis is that clinically relevant maternal and neonatal outcomes will not significantly differ between the two arms. We will pursue the following specific aims: 1) Determine the effect of room air, compared with supplemental O2, on neonatal morbidity among patients with Category II EFM and 2) Determine the effect of room air, compared with supplemental O2, on rates of operative delivery. A total of 2124 patients will be randomized to provide adequate power to detect clinically meaningful noninferiority margins for the above stated outcomes.

抽象的美国每年有 300 万临产妇女，其中 80% 以上接受过分娩期间连续电子胎儿监护 (EFM)。此类监测的目的是识别胎儿缺氧并防止转变为酸血症、加速手术分娩和/或新生儿发病。 II 类 EFM 是最常见的胎心率特征组，与变量相关酸血症的风险。对 II 类 EFM 的一种常见反应是母亲补充氧气 (O2)。这给予 O2 的理论依据是，它增加了向缺氧胎儿转移的 O2，从而逆转缺氧和预防酸血症。这种做法非常常用，以至于三分之二的患者接受了在分娩过程中的某个时刻补充氧气。然而，尽管有理论依据，却没有严格的数据以支持其广泛使用。我们的试点随机非劣效性试验发表在《JAMA Pediatrics》上，证明室内空气在改善脐动脉乳酸（脐动脉乳酸的替代标志物）方面并不劣于 O2 胎儿酸血症和新生儿发病率。我们随后对调查 O2 的随机试验进行荟萃分析与剖腹产或阴道分娩时的室内空气相比，发现脐动脉 pH 值没有差异，室内空气组和 O2 组之间的酸血症率和新生儿重症监护病房入院率。重要的是，没有一项试验研究新生儿或孕产妇发病率的重要临床指标，并且只有一项试验在 II 类 EFM 的设置中研究了 O2。目前的证据在几个方面受到限制。首先，现有的分娩中 O2 研究在 O2 的剂量、持续时间和时间安排上各不相同。第二，只有一个试点试验调查了补充氧气对于 ACOG 推荐的 II 类适应症的效用 EFM。第三，所有研究都使用了新生儿发病率的替代指标，例如脐带气体或新生儿重症监护病房入院。最后，没有一项研究能够评估 O2 的影响用于治疗宫内缺氧或手术分娩的新生儿临床后遗症。没有这些数据无法得出明确的结果，无法提出管理 II 类 EFM 的基于证据的建议。为了填补这一重要的知识空白，我们提出了一项大型、多中心、随机的 O2 非劣效性试验 II 类 EFM 临产患者的补充与室内空气比较。我们的中心假设是临床相关的孕产妇和新生儿结局在两组之间不会有显着差异。我们将追求以下具体目标： 1) 确定室内空气与补充氧气相比的效果，对 II 类 EFM 患者新生儿发病率的影响以及 2) 确定室内空气的影响，与补充氧气相比，对手术分娩率的影响。总共 2124 名患者将被随机分组提供足够的能力来检测上述内容的临床意义的非劣效性界限结果。