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
NCT Number: NCT02464917
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Long Beach, California, 90806, United States
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
Exclusion criteria
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
marker for metabolic acidosis
Time frame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
marker for metabolic acidosis
Time frame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
marker for metabolic acidosis
Time frame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
marker for metabolic acidosis
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)
Time frame: completed once infant is discharged home; anticipate 1-4 days
syndrome typically affecting premature babies due to immature lung maturation or development
Time frame: completed once infant is discharged home; anticipate 1-4 days
condition that affects newborn bowels where the tissue undergoes necrosis
Time frame: completed once infant is discharged home; anticipate 1-4 days
condition that causes bleeding within the brain typically affecting premature babies
Time frame: completed once infant is discharged home; anticipate 1-4 days
needing supplemental oxygen for the newborn through breathing device
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.
Time frame: completed once infant is discharged home; anticipate 1-4 days
MemorialCare Health System
Other
Acronym: SOS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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