Effect of CPAP on Fetal pH at Scheduled C-section in Morbidly Obese Women

Study Overview
=================
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.

Official Title
-----------------
Effect of Continuous Positive Airway Pressure on Fetal pH at Time of Scheduled Cesarean Delivery in Morbidly Obese Women

Conditions
-----------------
Morbid Obesity, Cesarean Delivery Affecting Fetus

Intervention / Treatment
-----------------
* Device: CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Positive Airway Pressure<br>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. | Device: CPAP<br>* CPAP is a form of noninvasive positive pressure ventilation (NPPV). CPAP works to maintain adequate levels of PO2 and PCO2 through improved alveolar ventilation and maintenance of upper-airway patency.<br>* Other names: Continuous Positive Airway Pressure;|
| No Intervention: Nasal Cannula<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Umbilical Cord Arterial pH | We hypothesize that neonates born to mothers wearing CPAP during the cesarean section will have a higher umbilical artery pH. | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with use of CPAP | Survey will be used to determine patient experience and satisfaction | Within 4 days following delivery (prior to discharge from hospital) | 
| Effect of CPAP on maternal acid base status with analysis of venous blood gas | Maternal venous blood gas will be analyzed at the time of uterine incision to measure the acid base status | At time of uterine incision | 
| Effect of maternal CPAP use on neonatal Apgar scores | Apgar scores will be compared between 2 groups | At delivery | 
| Effect of maternal CPAP use on composite neonatal outcome | Perinatal death, respiratory support, Apgar score <=3 at 5 min, hypoxic ischemic encephalopathy, hypotension requiring vasopressor support | At delivery | 
| Effect of duration in supine position prior to delivery on neonatal acid base status | Neonatal venous blood gas will be analyzed to determine the acid base status as it correlates to length of time in maternal supine position | At delivery | 
| Effect of duration in supine position prior to delivery on maternal acid base status | Maternal venous blood gas will be analyzed to determine the acid base status as it correlates to length of time in supine position | At delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fetal pH, CPAP, Continuous Positive Airway Pressure