Effect of Continuous Positive Airway Pressure on Fetal pH at Time of Scheduled Cesarean Delivery in Morbidly Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Umbilical Cord Arterial pH
研究概览
简要总结
The objective of our study is to evaluate the effect of CPAP on umbilical cord acid base status in morbidly obese women at the time of scheduled cesarean delivery. We hypothesize that neonates born to mothers wearing CPAP during the cesarean section will have a higher umbilical artery pH.
详细描述
This is a randomized control trial comparing CPAP to routine airway management in morbidly obese patients undergoing scheduled cesarean delivery. Morbidly obese women meeting criteria for inclusion will be approached for participation. Women who are scheduled for cesarean delivery at Sentara Norfolk General Hospital will be approached at a prenatal appointment prior to scheduled date of delivery. If a woman agrees to participate in the study, she will be counseled and consented at that time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Pregnant women between the ages of 18-45
- •Body mass index of 40 kg/m2 or greater at the time patient is scheduled for cesarean delivery
- •Singleton gestation
- •Scheduled for primary or repeat cesarean delivery at Sentara Norfolk General Hospital
- •Gestational age between 37+0 and 41+0 weeks at the time of delivery
- •Non-stress test on admission with moderate variability, without repetitive late or variable decelerations
- •Negative SARS-CoV-2 PCR test within 72 hours of procedure
排除标准
- •Fetal growth restriction
- •Active pulmonary diseases to include pneumonia, sarcoidosis, pulmonary hypertension, moderate or severe persistent asthma
- •Suspected placenta accreta based on prenatal sonographic evaluation
- •Active maternal infection to include pyelonephritis, appendicitis, upper respiratory tract infection, urinary tract infection or suspected intra-amniotic infection
- •SARS-CoV-2 positive test within past 10 days or ongoing symptoms of SARS-CoV-2 to include cough, fever or shortness of breath with positive test greater than 10 days prior, or history of hospitalization for SARS-CoV-2 infection
- •Fetus with aneuploidy or major anomaly
- •Enrolled in another trial that may affect outcome
研究组 & 干预措施
Continuous Positive Airway Pressure
Those randomized to CPAP will be fitted with CPAP face mask or nasal device by the respiratory therapist and permitted to trial the machine to ensure proper use and fit. CPAP settings: CPAP AUTO 5-20 cm H20 will be utilized. The CPAP device will then be removed. The subject will then be placed in the supine position with a standard roll placed under the right maternal hip. Those randomized to CPAP will have the device applied and machine turned on. For those randomized to routine airway management, nasal cannula with oxygen 2L/min will be applied and this will be titrated to achieve a maternal SpO2 > 95%. End tidal CO2 monitors will be applied to both patient groups.
干预措施: CPAP (Device)
Nasal Cannula
For those randomized to routine airway management, nasal cannula with oxygen 2L/min will be applied and this will be titrated to achieve a maternal SpO2 > 95%. End tidal CO2 monitors will be applied to both patient groups.
结局指标
主要结局
Umbilical Cord Arterial pH
时间窗: At delivery
We hypothesize that neonates born to mothers wearing CPAP during the cesarean section will have a higher umbilical artery pH.
次要结局
- Patient satisfaction with use of CPAP(Within 4 days following delivery (prior to discharge from hospital))
- Effect of CPAP on maternal acid base status with analysis of venous blood gas(At time of uterine incision)
- Effect of maternal CPAP use on neonatal Apgar scores(At delivery)
- Effect of maternal CPAP use on composite neonatal outcome(At delivery)
- Effect of duration in supine position prior to delivery on neonatal acid base status(At delivery)
- Effect of duration in supine position prior to delivery on maternal acid base status(At delivery)