Cesarean Delivery Affecting Fetus, Morbid Obesity
Conditions
Keywords
Fetal pH, CPAP, Continuous Positive Airway Pressure
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.
Interventions
DEVICECPAP
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.
Sponsors
Eastern Virginia Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| 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 |
Countries
United States
Outcome results
None listed