The Comparative Effectiveness of Liberal Versus Restricted Maternal Administration of Oxygen During Labor: a Controlled Before and After Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 844
- 试验地点
- 1
- 主要终点
- Number of Participants Who Delivered by Cesarean
研究概览
简要总结
The objective of this study is to determine if a strategy of indicated compared to liberal oxygen administration in labor decreases the rate of cesarean delivery. The hypothesis is that women who undergo a strategy of indicated compared to liberal oxygen administration in labor will have lower rate of cesarean delivery and fetal acidemia at birth.
详细描述
This is a single-site before and after study comparing the strategy of liberal versus indicated use of maternal oxygen in the first and second stages of labor in the setting of a category 2 fetal heart rate tracing (FHR) tracing, as defined by American Congress of Obstetrics and Gynecology (ACOG) and National Institute of Child Health and Human Development (NICHD) guidelines. All patients who are at term and are undergoing labor at Memorial Hermann Hospital in Houston, Texas during the time frame of the study will be included in the study. The study will be conducted over 18 weeks. It will involve two 8 week time periods during which all patients will under either a strategy of liberal administration of oxygen use (current practice) in the "before" portion of the study and indicated administration of oxygen in the "after" portion of the study (new practice). There will be a transition period where training, education, and audit + feedback will be done to prepare for a strategy of indicated administration of oxygen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with singleton gestation between 37 weeks 0 days to 42 weeks 0 days gestation who present to labor and delivery at Memorial Hermann Hospital in Houston, TX for planned labor attempt.
排除标准
- •Lethal fetal anomaly defined as anomaly in which the fetus is unlikely to survive or the neonate is not expected to survive to initial hospital discharge
- •Antepartum or intrapartum fetal demise
- •Preexisting maternal conditions requiring oxygen for maternal indication, including but not limited to: Asthma that has required intubation or hospitalization in the past or currently requiring steroids (either inhaled or oral); Chronic obstructive pulmonary disease; Chronic bronchitis; Congestive heart failure/peripartum cardiomyopathy; Pneumonia; Pulmonary edema; Pulmonary embolus
研究组 & 干预措施
Liberal use of maternal oxygen
Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician
干预措施: Liberal use of maternal oxygen (Drug)
Indicated use of maternal oxygen
Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
干预措施: Indicated use of maternal oxygen (Drug)
结局指标
主要结局
Number of Participants Who Delivered by Cesarean
时间窗: at time of birth
次要结局
- Number of Participants With Clinical Chorioamnionitis(during labor)
- Number of Participants With Umbilical Artery pH (Potential Hydrogen) < 7.10 at Birth(at time of birth)
- Number of Participants Who Delivered by Cesarean for Non-reassuring Fetal Status(at time of birth)
- Number of Participants Whose Infants Had an Apgar Score < 7 at 5 Minutes(5 minutes after birth)
- Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen(during labor)
- Number of Participants Whose Infants Were Admitted to the Neonatal Intensive Care Unit (NICU)(from time of birth to discharge from hospital (an average of 2-4 days))
- Total Duration of Maternal Oxygen Use(during labor)
研究者
Nanaama Ankumah Bentum
Clinical Fellow PGY 6
The University of Texas Health Science Center, Houston