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Positive Airway Pressure Device

Continuous Positive Airway Pressure for Obesity

N/A
Waitlist Available
Led By Tracey DeYoung, MD
Research Sponsored by Eastern Virginia Medical School
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at delivery
Awards & highlights

Study 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.

Eligible Conditions
  • Obesity
  • Cesarean Delivery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Umbilical Cord Arterial pH
Secondary outcome measures
Effect of CPAP on maternal acid base status with analysis of venous blood gas
Effect of duration in supine position prior to delivery on maternal acid base status
Effect of duration in supine position prior to delivery on neonatal acid base status
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Continuous Positive Airway PressureExperimental Treatment1 Intervention
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.
Group II: Nasal CannulaActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPAP
2013
Completed Phase 3
~5460

Find a Location

Who is running the clinical trial?

Eastern Virginia Medical SchoolLead Sponsor
69 Previous Clinical Trials
14,371 Total Patients Enrolled
Tracey DeYoung, MDPrincipal InvestigatorEastern Virginia Medical School

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
JamaJournal
Trends in Obesity Among Adults in the United States, 2005 to 2014
Flegal, Katherine M., Deanna Kruszon-Moran, Margaret D. Carroll, Cheryl D. Fryar, and Cynthia L. Ogden. 2016. “Trends in Obesity Among Adults in the United States, 2005 to 2014”. Jama. American Medical Association (AMA). doi:10.1001/jama.2016.6458.
clinicaltrials.govStudy
Effect of CPAP on Fetal pH at Scheduled C-section in Morbidly Obese Women
2021. "Effect of CPAP on Fetal pH at Scheduled C-section in Morbidly Obese Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04993651.
~23 spots leftby Apr 2025
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