Effect of CPAP on Fetal pH at Scheduled C-section in Morbidly Obese Women
- Conditions
- Cesarean Delivery Affecting FetusMorbid Obesity
- Interventions
- Device: CPAP
- Registration Number
- NCT04993651
- Lead Sponsor
- Eastern Virginia Medical School
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuous Positive Airway Pressure CPAP 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.
- Primary Outcome Measures
Name Time Method Umbilical Cord Arterial pH At delivery We hypothesize that neonates born to mothers wearing CPAP during the cesarean section will have a higher umbilical artery pH.
- Secondary Outcome Measures
Name Time Method Patient satisfaction with use of CPAP Within 4 days following delivery (prior to discharge from hospital) Survey will be used to determine patient experience and satisfaction
Effect of CPAP on maternal acid base status with analysis of venous blood gas At time of uterine incision Maternal venous blood gas will be analyzed at the time of uterine incision to measure the acid base status
Effect of maternal CPAP use on neonatal Apgar scores At delivery Apgar scores will be compared between 2 groups
Effect of maternal CPAP use on composite neonatal outcome At delivery Perinatal death, respiratory support, Apgar score \<=3 at 5 min, hypoxic ischemic encephalopathy, hypotension requiring vasopressor support
Effect of duration in supine position prior to delivery on neonatal acid base status At delivery Neonatal venous blood gas will be analyzed to determine the acid base status as it correlates to length of time in maternal supine position
Effect of duration in supine position prior to delivery on maternal acid base status At delivery Maternal venous blood gas will be analyzed to determine the acid base status as it correlates to length of time in supine position
Trial Locations
- Locations (1)
Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States