Cesarean Section, Supplemental Oxygen, Umbilical Cord Gases
Conditions
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.
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.
Interventions
DEVICEDevice: simple facemask to administer supplemental oxygen
Sponsors
MemorialCare Health System
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Umbilical Cord pH Levels | collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection | marker for metabolic acidosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Umbilical Cord Partial Pressure Carbon Dioxide (pCO2) | collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection | marker for metabolic acidosis |
| Umbilical Cord Bicarbonate (HCO3) | collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection | marker for metabolic acidosis |
| Number of Newborns With an Apgar Score <7 | 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) |
| Number of Newborns With Respiratory Distress Syndrome | completed once infant is discharged home; anticipate 1-4 days | syndrome typically affecting premature babies due to immature lung maturation or development |
| Umbilical Cord Base Excess | collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection | marker for metabolic acidosis |
| Number of Newborns With Intraventricular Hemorrhage | completed once infant is discharged home; anticipate 1-4 days | condition that causes bleeding within the brain typically affecting premature babies |
| Number of Newborns Requiring Intubation | completed once infant is discharged home; anticipate 1-4 days | needing supplemental oxygen for the newborn through breathing device |
| Number of Newborns Admitted to the NICU (Neonatal Intensive Care Unit) | 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. |
| Neonatal Mortality | completed once infant is discharged home; anticipate 1-4 days | — |
| Number of Newborns With Necrotizing Enterocolitis | completed once infant is discharged home; anticipate 1-4 days | condition that affects newborn bowels where the tissue undergoes necrosis |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Supplemental Oxygen Subjects in this arm will receive 10L/min via simple facemask
Device: simple facemask to administer supplemental oxygen | 33 |
| Room Air This control arm will receive no supplemental oxygen | 32 |
| Total | 65 |
Baseline characteristics
| Characteristic | Supplemental Oxygen | Room Air | Total |
|---|---|---|---|
| Age, Continuous | 33 years | 31 years | 32 years |
| Race/Ethnicity, Customized Asian | 6 Participants | 6 Participants | 12 Participants |
| Race/Ethnicity, Customized Black | 6 Participants | 8 Participants | 14 Participants |
| Race/Ethnicity, Customized Caucasian | 5 Participants | 6 Participants | 11 Participants |
| Race/Ethnicity, Customized Hispanic | 16 Participants | 11 Participants | 27 Participants |
| Race/Ethnicity, Customized Other / unknown | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Female | 33 Participants | 32 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
Umbilical Cord pH Levels
marker for metabolic acidosis
Time frame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Supplemental Oxygen | Umbilical Cord pH Levels | 7.29 pH |
| Room Air | Umbilical Cord pH Levels | 7.28 pH |
Secondary
Neonatal Mortality
Time frame: completed once infant is discharged home; anticipate 1-4 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supplemental Oxygen | Neonatal Mortality | 0 Participants |
| Room Air | Neonatal Mortality | 0 Participants |
Secondary
Number of Newborns Admitted to the NICU (Neonatal Intensive Care Unit)
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supplemental Oxygen | Number of Newborns Admitted to the NICU (Neonatal Intensive Care Unit) | 0 Participants |
| Room Air | Number of Newborns Admitted to the NICU (Neonatal Intensive Care Unit) | 0 Participants |
Secondary
Number of Newborns Requiring Intubation
needing supplemental oxygen for the newborn through breathing device
Time frame: completed once infant is discharged home; anticipate 1-4 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supplemental Oxygen | Number of Newborns Requiring Intubation | 0 Participants |
| Room Air | Number of Newborns Requiring Intubation | 0 Participants |
Secondary
Number of Newborns With an Apgar Score <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 at 5 minutes of life, Apgar <7
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Supplemental Oxygen | Number of Newborns With an Apgar Score <7 | 0 newborns |
| Room Air | Number of Newborns With an Apgar Score <7 | 0 newborns |
Secondary
Number of Newborns With Intraventricular Hemorrhage
condition that causes bleeding within the brain typically affecting premature babies
Time frame: completed once infant is discharged home; anticipate 1-4 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supplemental Oxygen | Number of Newborns With Intraventricular Hemorrhage | 0 Participants |
| Room Air | Number of Newborns With Intraventricular Hemorrhage | 0 Participants |
Secondary
Number of Newborns With Necrotizing Enterocolitis
condition that affects newborn bowels where the tissue undergoes necrosis
Time frame: completed once infant is discharged home; anticipate 1-4 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supplemental Oxygen | Number of Newborns With Necrotizing Enterocolitis | 0 Participants |
| Room Air | Number of Newborns With Necrotizing Enterocolitis | 0 Participants |
Secondary
Number of Newborns With Respiratory Distress Syndrome
syndrome typically affecting premature babies due to immature lung maturation or development
Time frame: completed once infant is discharged home; anticipate 1-4 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supplemental Oxygen | Number of Newborns With Respiratory Distress Syndrome | 0 Participants |
| Room Air | Number of Newborns With Respiratory Distress Syndrome | 0 Participants |
Secondary
Umbilical Cord Base Excess
marker for metabolic acidosis
Time frame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Supplemental Oxygen | Umbilical Cord Base Excess | -1.3 mEq/L |
| Room Air | Umbilical Cord Base Excess | -1.6 mEq/L |
Secondary
Umbilical Cord Bicarbonate (HCO3)
marker for metabolic acidosis
Time frame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Supplemental Oxygen | Umbilical Cord Bicarbonate (HCO3) | 26 mEq/L |
| Room Air | Umbilical Cord Bicarbonate (HCO3) | 26 mEq/L |
Secondary
Umbilical Cord Partial Pressure Carbon Dioxide (pCO2)
marker for metabolic acidosis
Time frame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Supplemental Oxygen | Umbilical Cord Partial Pressure Carbon Dioxide (pCO2) | 58 mmHg |
| Room Air | Umbilical Cord Partial Pressure Carbon Dioxide (pCO2) | 58 mmHg |