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.

摘要 在美国每年分娩和分娩的300万女性中，超过80%的人经历了 分娩期间连续电子胎儿监护(EFM)。这种监测的目标是识别胎儿 低氧和防止过渡到酸血症、加速手术分娩和/或新生儿发病率。 第二类EFM，最常观察到的胎心率特征组，与变量相关 酸血症的风险。对第二类EFM的一个常见反应是母体补充氧气(O2)。这个 给氧的理论基础是，它增加了氧气向缺氧胎儿的转移，从而逆转了 低氧和预防酸血症。这种做法非常普遍，以至于每3名患者中就有2名接受了 在分娩过程中的某个时间点补充氧气。然而，尽管有理论基础，但没有严格的数据 以支持它的广泛使用。我们的先导随机非自卑试验发表在《美国医学会儿科杂志》上， 证明了室内空气在改善脐动脉乳酸方面不逊于氧气，这是一种替代指标 胎儿酸血症与新生儿发病率。我们随后对调查氧气的随机试验的荟萃分析 与剖腹产或阴道分娩时的室内空气相比，脐动脉的pH值没有差异， 空气组和氧气组之间的酸血症发生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产妇发病率的重要临床指标，只有一项试验 在第二类EFM的设置中研究了O2。目前的证据状态在几个方面受到限制。首先， 现有关于产中氧气的研究在给氧的剂量、持续时间和时间上各不相同。第二，只有一个 先导试验调查了补充氧气对ACOG推荐的II类适应症的效用 EFM。第三，所有的研究都使用了新生儿发病率的替代指标，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氧气的影响 宫内缺氧或手术分娩新生儿临床后遗症的处理。在没有数据的情况下 对于最终结果，无法提出管理第二类EFM的循证建议。 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非劣势试验 分娩中II类EFM患者的补充剂与室内空气的比较。我们的中心假设是 临床上相关的产妇和新生儿结局在两组之间不会有显著差异。我们 将追求以下具体目标：1)与补充O2相比，确定室内空气的影响， 第二类EFM患者的新生儿发病率和2)确定室内空气的影响， 手术分娩率与补氧组比较，差异有统计学意义(P<0.05)。总共2124名患者将被随机分组 提供足够的能力来检测上述有临床意义的非劣质边际 结果。