Clinical trial NCT02464917: Supplemental Oxygen Study
Official title: Supplemental Oxygen Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Supplemental Oxygen
Umbilical Cord Gases
Lead sponsor: MemorialCare Health System
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Umbilical Cord pH Levels
timeFrame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
Secondary outcomes:
measure: Umbilical Cord Base Excess
timeFrame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
measure: Umbilical Cord Partial Pressure Carbon Dioxide (pCO2)
timeFrame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
measure: Umbilical Cord Bicarbonate (HCO3)
timeFrame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
measure: Number of Newborns With an Apgar Score <7
timeFrame: completed at 5 minutes of life, Apgar <7
measure: Number of Newborns With Respiratory Distress Syndrome
timeFrame: completed once infant is discharged home; anticipate 1-4 days
measure: Number of Newborns With Necrotizing Enterocolitis
timeFrame: completed once infant is discharged home; anticipate 1-4 days
measure: Number of Newborns With Intraventricular Hemorrhage
timeFrame: completed once infant is discharged home; anticipate 1-4 days
measure: Number of Newborns Requiring Intubation
timeFrame: completed once infant is discharged home; anticipate 1-4 days
measure: Number of Newborns Admitted to the NICU (Neonatal Intensive Care Unit)
timeFrame: completed once infant is discharged home; anticipate 1-4 days
measure: Neonatal Mortality
timeFrame: completed once infant is discharged home; anticipate 1-4 days
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital
state: California
Study officials:
affiliation: MemorialCare Health System
name: Michael Nageotte, MD
role: PRINCIPAL_INVESTIGATOR
References: