Safety and Risk Assessment of Obese Parturient Underwent Cesarean Section(CS) Delivery Under General Anesthesia or Intraspinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 主要终点
- Patients numbers of obese parturient complications
研究概览
简要总结
900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were divided into 3 groups: Morbid Obesity group (n=300) with body mass index (BMI) >40 kg/m2 , severe Obesity group (n=300) with 30 kg/m2≤BMI ≤40 kg/m2 and non-Obesity group(n=300) with BMI<30 kg/m2. Findings Between January 1, 2013 and September 30, 2016, a total of 1000 women met inclusion criteria and 900 women received allocated intervention. All patients were divided into three groups: Morbid Obesity group(n=300), Severe Obesity group(n=300) and non-Obesity group(n=300) according to body mass index (BMI) >40 kg/m2, 30 kg/m2≤BMI ≤40 kg/m2 and BMI<30 kg/m2.900 patients completed the protocol and related data were analysed.
详细描述
900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were divided into 3 groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 24 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with ASA Physical Status gradeΙΙ～ΙΙΙ.
排除标准
- •scoliosis, congenital heart disease, lung, liver, kidney diseases or increased intracranial pressure (ICP)
结局指标
主要结局
Patients numbers of obese parturient complications
时间窗: 2 years
Patients numbers of emergency, fetal macrosomia, gestational diabetes mellitus (GMD), CS history, fetal distress, elderly parturient women(≥35 years), prenatal fever, arrhythmias, abnormalities of the heart, hypertension(pre-eclampsia), multiple pregnancy, precious child, amniotic fluid abnormality, amout of bleeding, neonate Apgar's Score(1min), Apgar's Score(5min), and patients numbers of EA, GA, PACU (Postanesthesia Care Unit ) and ICU (Intensive Care Unit) for duration of hospital stay and anesthesia puncture times with 5\>n≥3 and n≥5 in three groups included non-Obesity group, severe Obesity group and Morbid Obesity group were also recorded. In addition, we also recorded puncture patients numbers in sitting position for all groups.
次要结局
未报告次要终点
研究者
Zeyong Yang
International Peace Maternity and Child Health Hospital
Shanghai Jiao Tong University School of Medicine