A Randomized Controlled Trial Evaluating Maternal Tilt During Cesarean Section
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- neonatal base deficit from uterine artery immediately after cesarean delivery of the fetus
研究概览
简要总结
During Cesarean Delivery pregnant women are frequently tilted to the left 15 degress to reduce compression of the major blood vessels by the uterus. Despite this common practice, there is no conclusive evidence to support this practice. In fact it may even be deleterious to have women positioned in this position. The aim of the study is to determine whether or not tilting women to the left during cesarean section (CS) is helpful or detrimental. The authors hypothesize that left uterine displacement of 15 degrees, which is commonly employed, is useless for preventing compression of these blood vessels. To investigate this question, women will be randomly assigned to either be tilted 15 degrees to the left during CS or positioned flat on the table. Fetal acid base status, vasopressor/phenylephrine use, patient satisfaction, maternal complications, and fetal complications will all be collected and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •term pregnant women with an uncomplicated pregnancy course undergoing scheduled cesarean delivery
- •≥18 years old
- •ASA 1 and 2 (i.e., patient is completely healthy (1) or has mild systemic disease (2)
- •Able and willing to consent to participate
排除标准
- •<18 years old
- •maternal cardiac/pulmonary/hematologic disorders/renal failure
- •drug/alcohol/tobacco use during pregnancy
- •essential or pregnancy-induced hypertension
- •diabetes greater than 10 years
- •pre-eclampsia or abruptio placenta
- •<37 weeks gestation
- •hemoglobin < 7 g/dL
- •intrauterine growth retardation
- •fetal distress or fetal anomaly
- •Transverse lie
- •Ruptured membranes
- •Severe polyhydramnios or oligohydramnios
- •Multiple gestation
- •severe scoliosis or kyphosis,
- •uterine abnormalities (e.g., large fibroids, bicornuate uterus)
- •Failed spinal (sensory level < T6 after 15 minutes)
- •need to convert to general anesthesia before delivery
结局指标
主要结局
neonatal base deficit from uterine artery immediately after cesarean delivery of the fetus
时间窗: One data point will be used. The neonatal gas from the uterine artery immediately after delivery
次要结局
- APGAR scores of the newborn as assessed by the neonatologist immediately after cesarean delivery(1 and 5 minute apgar scores of the newborn fetus will be compared)
- total phenylephrine use in micrograms prior to delivery(The aggregate of the phenylephrine used immediately after spinal (total of 20 minutes) or until delivery of the baby)