Supplemental Oxygen Study (SOS)

MemorialCare Health System

Status: Completed

Conditions: Cesarean Section; Umbilical Cord Gases; Supplemental Oxygen

Treatments: Device: Device: simple facemask to administer supplemental oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT02464917

491-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Supplemental oxygen

Experimental group

Description:

Subjects in this arm will receive 10L/min via simple facemask

Treatment:

Device: Device: simple facemask to administer supplemental oxygen

Room air

No Intervention group

Description:

This control arm will receive no supplemental oxygen