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

Primary Purpose

Morbid Obesity, Cesarean Delivery Affecting Fetus

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CPAP

About this trial

This is an interventional prevention trial for Morbid Obesity focused on measuring Fetal pH, CPAP, Continuous Positive Airway Pressure

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Continuous Positive Airway Pressure

Nasal Cannula

Arm 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.

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.

Outcomes

Primary Outcome Measures

Umbilical Cord Arterial pH

We hypothesize that neonates born to mothers wearing CPAP during the cesarean section will have a higher umbilical artery pH.

Secondary Outcome Measures

Patient satisfaction with use of CPAP

Survey will be used to determine patient experience and satisfaction

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

Effect of maternal CPAP use on neonatal Apgar scores

Apgar scores will be compared between 2 groups

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

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

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

Full Information

NCT ID

NCT04993651

First Posted

June 21, 2021

Last Updated

April 7, 2022

Sponsor

Eastern Virginia Medical School

1. Study Identification

Unique Protocol Identification Number

NCT04993651

Brief Title

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

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 11, 2021 (Actual)

Primary Completion Date

August 31, 2022 (Anticipated)

Study Completion Date

August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eastern Virginia Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Morbid Obesity, Cesarean Delivery Affecting Fetus

Keywords

Fetal pH, CPAP, Continuous Positive Airway Pressure

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Continuous Positive Airway Pressure

Arm Type

Experimental

Arm Description

Arm Title

Nasal Cannula

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

CPAP

Other Intervention Name(s)

Continuous Positive Airway Pressure

Intervention Description

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.

Primary Outcome Measure Information:

Title

Umbilical Cord Arterial pH

Description

We hypothesize that neonates born to mothers wearing CPAP during the cesarean section will have a higher umbilical artery pH.

Time Frame

At delivery

Secondary Outcome Measure Information:

Title

Patient satisfaction with use of CPAP

Description

Survey will be used to determine patient experience and satisfaction

Time Frame

Within 4 days following delivery (prior to discharge from hospital)

Title

Effect of CPAP on maternal acid base status with analysis of venous blood gas

Description

Maternal venous blood gas will be analyzed at the time of uterine incision to measure the acid base status

Time Frame

At time of uterine incision

Title

Effect of maternal CPAP use on neonatal Apgar scores

Description

Apgar scores will be compared between 2 groups

Time Frame

At delivery

Title

Effect of maternal CPAP use on composite neonatal outcome

Description

Perinatal death, respiratory support, Apgar score <=3 at 5 min, hypoxic ischemic encephalopathy, hypotension requiring vasopressor support

Time Frame

At delivery

Title

Effect of duration in supine position prior to delivery on neonatal acid base status

Description

Neonatal venous blood gas will be analyzed to determine the acid base status as it correlates to length of time in maternal supine position

Time Frame

At delivery

Title

Effect of duration in supine position prior to delivery on maternal acid base status

Description

Maternal venous blood gas will be analyzed to determine the acid base status as it correlates to length of time in supine position

Time Frame

At delivery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kristin Ayers, MPH

Phone

7574460579

ayerskl@evms.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tracey DeYoung, MD

Organizational Affiliation

Eastern Virginia Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tracey DeYoung, MD

Phone

757-446-7900

deyountd@evms.edu

First Name & Middle Initial & Last Name & Degree

Kristin Ayers, MPH

Phone

7574460579

ayerskl@evms.edu

First Name & Middle Initial & Last Name & Degree

Tracey DeYoung, MD

First Name & Middle Initial & Last Name & Degree

Alfred Abuhamad, MD

12. IPD Sharing Statement

Plan to Share IPD

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

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