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

Eastern Virginia Medical School (EVMS)

Status: Completed

Conditions: Cesarean Delivery Affecting Fetus; Morbid Obesity

Treatments: Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT04993651

CPAP on Fetal pH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Continuous Positive Airway Pressure

Experimental group

Description:

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.

Treatment:

Device: CPAP

Nasal Cannula

No Intervention group

Description:

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.