- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02464917
Supplemental Oxygen Study (SOS)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Long Beach, California, United States, 90806
- Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supplemental oxygen
Subjects in this arm will receive 10L/min via simple facemask
|
|
No Intervention: Room air
This control arm will receive no supplemental oxygen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Umbilical Cord pH Levels
Time Frame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
|
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
Time Frame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
|
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)
Time Frame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
|
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)
Time Frame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
|
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
Time Frame: 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)
|
completed at 5 minutes of life, Apgar <7
|
Number of Newborns With Respiratory Distress Syndrome
Time Frame: completed once infant is discharged home; anticipate 1-4 days
|
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
Time Frame: completed once infant is discharged home; anticipate 1-4 days
|
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
Time Frame: completed once infant is discharged home; anticipate 1-4 days
|
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
Time Frame: completed once infant is discharged home; anticipate 1-4 days
|
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)
Time Frame: 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.
|
completed once infant is discharged home; anticipate 1-4 days
|
Neonatal Mortality
Time Frame: completed once infant is discharged home; anticipate 1-4 days
|
completed once infant is discharged home; anticipate 1-4 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Nageotte, MD, MemorialCare Health System
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 491-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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