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Completed

NCT Number: NCT02464917

Supplemental Oxygen Study

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device: simple facemask to administer supplemental oxygen

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  10. Neonatal Mortality

    Time frame: completed once infant is discharged home; anticipate 1-4 days

Sponsors and collaborators

Lead sponsor

MemorialCare Health System

Other

Registry information

Acronym: SOS

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 8, 2015
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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