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

• 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
• 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' 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

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 在美国每年劳动和分娩的300万妇女中，超过80％ 分娩过程中连续电子胎儿监测（EFM）。这种监测的目的是确定胎儿 缺氧并防止过渡到酸血症，加快手术递送和/或新生儿发病率。 II类EFM是最常见的一组胎儿心率特征，与可变有关 酸血症的风险。对II类EFM的一种常见反应是母体氧（O2）补充。这 O2给药的理论理论原理是它增加了O2转移到低氧胎儿，从而逆转 缺氧和预防酸血症。这种做法是如此常用，以至于3个患者中有2名接受 在劳动期间的某个时候补充O2。但是，尽管理论原理，但没有严格的数据 支持其广泛使用。我们的飞行员随机非产试验，发表在《贾马儿科》中， 证明房间空气不属于O2，以改善脐动脉乳酸，这是一个替代标志物 胎儿酸血症和新生儿发病率。我们随后对研究O2的随机试验的荟萃分析 剖宫产时或阴道分娩时的房间空气发现脐动脉pH没有差异， 房间空气和O2组之间的酸血症和新生儿重症监护病房的入院率。重要的是， 没有一项试验研究新生儿或母体发病率的重要临床测量，只有一项试验 在II类EFM的设置中研究了O2。当前的证据状态在几种方面受到限制。首先， O2的现有研究在O2给药的剂量，持续时间和时间上有所不同。第二，只有一个 试点试验调查了对ACOG推荐II类的ACOG提示的补充效用 EFM。第三，所有研究都使用了新生儿发病率的替代措施，例如脐带气或 新生儿重症监护病房入院。最后，所有研究都没有动力评估O2的影响 在子宫缺氧或手术递送中的新生儿临床后遗症的给药。没有这些数据 无法提出确定的结果，基于循证的管理II类EFM的建议。 为了填补这一重要的知识差距，我们提出了一项大型多中心，随机的非劣效试验 II类EFM患者的补充与房间空气相比。我们的中心假设是 两臂之间与临床相关的母体和新生儿结局不会显着差异。我们 将追求以下特定目标：1）与补充O2相比，确定房间空气的影响 关于II类EFM患者的新生儿发病率和2）确定房间空气的影响， 与补充O2相比，手术交付率。总共2124名患者将被随机分配 提供足够的能力来检测上述临床意义的非劣效率 结果。