Supplemental Oxygen Study

Not Applicable

Completed

Conditions: Supplemental Oxygen
Umbilical Cord Gases
Cesarean Section

Registration Number: NCT02464917

Lead Sponsor: MemorialCare Health System

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 70

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Umbilical Cord pH Levels	collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection	marker for metabolic acidosis

Secondary Outcome Measures

Name	Time	Method
Umbilical Cord Partial Pressure Carbon Dioxide (pCO2)	collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection	marker for metabolic acidosis
Number of Newborns With Respiratory Distress Syndrome	completed once infant is discharged home; anticipate 1-4 days	syndrome typically affecting premature babies due to immature lung maturation or development
Number of Newborns With Intraventricular Hemorrhage	completed once infant is discharged home; anticipate 1-4 days	condition that causes bleeding within the brain typically affecting premature babies
Umbilical Cord Base Excess	collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection	marker for metabolic acidosis
Umbilical Cord Bicarbonate (HCO3)	collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection	marker for metabolic acidosis
Neonatal Mortality	completed once infant is discharged home; anticipate 1-4 days
Number of Newborns With an Apgar Score <7	completed at 5 minutes of life, Apgar <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)
Number of Newborns With Necrotizing Enterocolitis	completed once infant is discharged home; anticipate 1-4 days	condition that affects newborn bowels where the tissue undergoes necrosis
Number of Newborns Requiring Intubation	completed once infant is discharged home; anticipate 1-4 days	needing supplemental oxygen for the newborn through breathing device
Number of Newborns Admitted to the NICU (Neonatal Intensive Care Unit)	completed once infant is discharged home; anticipate 1-4 days	if newborns need higher intensity of care they are transferred to the Neonatal Intensive Care Unit.

Trial Locations

Locations (1): Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital
🇺🇸
Long Beach, California, United States