Clinical trial NCT04993651: Effect of CPAP on Fetal pH at Scheduled C-section in Morbidly Obese Women
Official title: Effect of Continuous Positive Airway Pressure on Fetal pH at Time of Scheduled Cesarean Delivery in Morbidly Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Cesarean Delivery Affecting Fetus
Keywords: Fetal pH
CPAP
Continuous Positive Airway Pressure
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Umbilical Cord Arterial pH
timeFrame: At delivery
Secondary outcomes:
measure: Patient satisfaction with use of CPAP
timeFrame: Within 4 days following delivery (prior to discharge from hospital)
measure: Effect of CPAP on maternal acid base status with analysis of venous blood gas
timeFrame: At time of uterine incision
measure: Effect of maternal CPAP use on neonatal Apgar scores
timeFrame: At delivery
measure: Effect of maternal CPAP use on composite neonatal outcome
timeFrame: At delivery
measure: Effect of duration in supine position prior to delivery on neonatal acid base status
timeFrame: At delivery
measure: Effect of duration in supine position prior to delivery on maternal acid base status
timeFrame: At delivery
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: Tracey DeYoung, MD
role: PRINCIPAL_INVESTIGATOR
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