Supplemental Oxygen Study

Study Overview
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Brief Summary
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The purpose of this study is to compare umbilical cord gases in subjects receiving oxygen at 10L/min via simple facemask to subjects receiving room air in those presenting for scheduled cesarean sections.

Detailed Description
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Objective: To compare umbilical cord gases in subjects receiving oxygen at 10L/min via simple facemask to subjects receiving room air in those presenting for scheduled cesarean sections. The investigators hypothesize that umbilical artery pH levels will not be significantly lowered in the oxygenated group. Primary outcome: umbilical artery pH levels in the oxygenated versus room air group Secondary outcomes: Apgars, respiratory distress syndrome, necrotizing enterocolitis, interventricular hemorrhage, intubation, number of NICU days and neonatal mortality. Methods: Only term elective c-sections will be approached for study consent. Once enrolled subjects will be randomized either receive 10L/min via simple facemask or to room air. Once regional anesthesia is completed, then the facemask with oxygen will be placed. The time from oxygen administration to uterine incision will be at least 10 min. At the time of delivery umbilical cord gases will be collected by and will be processed within one hour of delivery. Inclusion criteria: 18 years or older Scheduled cesarean section Singleton Term gestation; at 37 0/7 weeks gestation or greater Exclusion criteria: Maternal lung disease including asthma Evidence of hypoxemia prior to enrollment Intrauterine growth restriction Chronic hypertension Preeclampsia Fetal anomalies Breech position Multiple Gestation Statistical analysis: Subjects will be randomized via block randomization. The estimated umbilical arterial pH in the scheduled cesarean section room air group is 7.31. To identify a 0.05 or greater difference between the control and treatment group, a power of 0.8, alpha of 0.05 the investigators would need 64 subjects total. To account for drop out the investigators intend to enroll a total of 70 subjects.

Official Title
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Supplemental Oxygen Study

Conditions
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Cesarean Section, Supplemental Oxygen, Umbilical Cord Gases

Intervention / Treatment
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* Device: Device: simple facemask to administer supplemental oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Scheduled cesarean section Singleton Term gestation Exclusion Criteria: Maternal lung disease including asthma Evidence of hypoxemia prior to enrollment Intrauterine growth restriction Chronic hypertension Preeclampsia Fetal anomalies Breech position Multiple gestation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplemental oxygen<br>Subjects in this arm will receive 10L/min via simple facemask | Device: Device: simple facemask to administer supplemental oxygen<br> <br> |
| No Intervention: Room air<br>This control arm will receive no supplemental oxygen | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Umbilical Cord pH Levels | marker for metabolic acidosis | collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Umbilical Cord Base Excess | marker for metabolic acidosis | collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection | 
| Umbilical Cord Partial Pressure Carbon Dioxide (pCO2) | marker for metabolic acidosis | collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection | 
| Umbilical Cord Bicarbonate (HCO3) | marker for metabolic acidosis | collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection | 
| Number of Newborns With an Apgar Score <7 | quick test performed on all babies once born that access how babies transition after birth. The following signs are given values of 0, 1, or 2 and added to compute the Apgar score. The higher the points the better. maximum points is 10. minimum score is 0. Signs: Color (0=blue/pale, 1=acrocyanotic, 2=completely pink), Heart rate (0=absent, 1=<100 minute, 2=>100 minute), Reflex irritability(0=no response, 1=grimace, 2=cry), muscle tone (0=limp, 1=some flexion, 2=active motion), Respiration (0=absent, 1=weak cry; hypoventilation, 2=good, crying) | completed at 5 minutes of life, Apgar <7 | 
| Number of Newborns With Respiratory Distress Syndrome | syndrome typically affecting premature babies due to immature lung maturation or development | completed once infant is discharged home; anticipate 1-4 days | 
| Number of Newborns With Necrotizing Enterocolitis | condition that affects newborn bowels where the tissue undergoes necrosis | completed once infant is discharged home; anticipate 1-4 days | 
| Number of Newborns With Intraventricular Hemorrhage | condition that causes bleeding within the brain typically affecting premature babies | completed once infant is discharged home; anticipate 1-4 days | 
| Number of Newborns Requiring Intubation | needing supplemental oxygen for the newborn through breathing device | completed once infant is discharged home; anticipate 1-4 days | 
| Number of Newborns Admitted to the NICU (Neonatal Intensive Care Unit) | if newborns need higher intensity of care they are transferred to the Neonatal Intensive Care Unit. | completed once infant is discharged home; anticipate 1-4 days | 
| Neonatal Mortality |  | completed once infant is discharged home; anticipate 1-4 days |