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

NCT04993651 | Completed FDA Device

• 1 other identifier: CPAP on Fetal pH
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Cesarean Delivery Affecting Fetus

Keywords

Fetal pH; CPAP; Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Continuous Positive Airway Pressure

EXPERIMENTAL

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

Nasal Cannula

NO INTERVENTION

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.

Interventions

CPAP DEVICE

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.

Also known as: Continuous Positive Airway Pressure

Continuous Positive Airway Pressure

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Virginia Medical School: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Related Publications (20)

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MeSH Terms

Conditions

Obesity, Morbid

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Tracey DeYoung, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: August 6, 2021
• Study Start: October 11, 2021
• Primary Completion: May 9, 2023
• Study Completion: June 30, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)