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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02464917
Other study ID # 491-14
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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