Supplemental Oxygen Study

Cesarean Section Clinical Trial

— SOS  

Official title:

Supplemental Oxygen Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464917
• Other study ID #: 491-14
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: November 2015

Study information

• Verified date: August 2019
• Source: MemorialCare Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Supplemental Oxygen
• Umbilical Cord Gases

Intervention

Device:
• Device: simple facemask to administer supplemental oxygen

Locations

Country	Name	City	State
United States	Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
MemorialCare Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Umbilical Cord Base Excess	marker for metabolic acidosis	collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
Secondary	Umbilical Cord Partial Pressure Carbon Dioxide (pCO2)	marker for metabolic acidosis	collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
Secondary	Umbilical Cord Bicarbonate (HCO3)	marker for metabolic acidosis	collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
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)	completed at 5 minutes of life, Apgar <7
Secondary	Number of Newborns With Respiratory Distress Syndrome	syndrome typically affecting premature babies due to immature lung maturation or development	completed once infant is discharged home; anticipate 1-4 days
Secondary	Number of Newborns With Necrotizing Enterocolitis	condition that affects newborn bowels where the tissue undergoes necrosis	completed once infant is discharged home; anticipate 1-4 days
Secondary	Number of Newborns With Intraventricular Hemorrhage	condition that causes bleeding within the brain typically affecting premature babies	completed once infant is discharged home; anticipate 1-4 days
Secondary	Number of Newborns Requiring Intubation	needing supplemental oxygen for the newborn through breathing device	completed once infant is discharged home; anticipate 1-4 days
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.	completed once infant is discharged home; anticipate 1-4 days
Secondary	Neonatal Mortality		completed once infant is discharged home; anticipate 1-4 days