Supplemental Oxygen Study
SOS
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 2, 2015
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
August 22, 2019
CompletedAugust 22, 2019
August 1, 2019
4 months
June 2, 2015
August 29, 2018
August 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Umbilical Cord pH Levels
marker for metabolic acidosis
collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
Secondary Outcomes (10)
Umbilical Cord Base Excess
collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
Umbilical Cord Partial Pressure Carbon Dioxide (pCO2)
collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
Umbilical Cord Bicarbonate (HCO3)
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
completed at 5 minutes of life, Apgar <7
Number of Newborns With Respiratory Distress Syndrome
completed once infant is discharged home; anticipate 1-4 days
- +5 more secondary outcomes
Study Arms (2)
Supplemental oxygen
EXPERIMENTALSubjects in this arm will receive 10L/min via simple facemask
Room air
NO INTERVENTIONThis control arm will receive no supplemental oxygen
Interventions
Eligibility Criteria
You may qualify if:
- years or older
- Scheduled cesarean section
- Singleton
- Term gestation
You may not qualify if:
- Maternal lung disease including asthma
- Evidence of hypoxemia prior to enrollment
- Intrauterine growth restriction
- Chronic hypertension
- Preeclampsia
- Fetal anomalies
- Breech position
- Multiple gestation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital
Long Beach, California, 90806, United States
Results Point of Contact
- Title
- Michael Nageotte, MD
- Organization
- Memorial Health Systems
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Nageotte, MD
MemorialCare Health System
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Maternal Fetal Medicine Division Director
Study Record Dates
First Submitted
June 2, 2015
First Posted
June 8, 2015
Study Start
June 1, 2015
Primary Completion
October 1, 2015
Study Completion
November 1, 2015
Last Updated
August 22, 2019
Results First Posted
August 22, 2019
Record last verified: 2019-08