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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
70
Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital
Long Beach, California, United States
Umbilical Cord pH Levels
marker for metabolic acidosis
Time frame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
Umbilical Cord Base Excess
marker for metabolic acidosis
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: completed once infant is discharged home; anticipate 1-4 days
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Number of Newborns With Necrotizing Enterocolitis
condition that affects newborn bowels where the tissue undergoes necrosis
Time frame: 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
Time frame: completed once infant is discharged home; anticipate 1-4 days
Number of Newborns Requiring Intubation
needing supplemental oxygen for the newborn through breathing device
Time frame: 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.
Time frame: completed once infant is discharged home; anticipate 1-4 days
Neonatal Mortality
Time frame: completed once infant is discharged home; anticipate 1-4 days