N/A
N=70
Supplemental Oxygen Study
Cesarean Section · Supplemental Oxygen · Umbilical Cord Gases
Bottom Line
View on ClinicalTrials.gov: NCT02464917 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Umbilical Cord pH Levels — 7.29; 7.28 pH
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Device: simple facemask to administer supplemental oxygen (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- MemorialCare Health System
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Umbilical Cord pH Levels |
7.29; 7.28 | — |
| SECONDARY Umbilical Cord Base Excess |
-1.3; -1.6 | — |
| SECONDARY Umbilical Cord Partial Pressure Carbon Dioxide (pCO2) |
58; 58 | — |
| SECONDARY Umbilical Cord Bicarbonate (HCO3) |
26; 26 | — |
| SECONDARY Number of Newborns With an Apgar Score <7 |
0; 0 | — |
| SECONDARY Number of Newborns With Respiratory Distress Syndrome |
0; 0 | — |
| SECONDARY Number of Newborns With Necrotizing Enterocolitis |
0; 0 | — |
| SECONDARY Number of Newborns With Intraventricular Hemorrhage |
0; 0 | — |
| SECONDARY Number of Newborns Requiring Intubation |
0; 0 | — |
| SECONDARY Number of Newborns Admitted to the NICU (Neonatal Intensive Care Unit) |
0; 0 | — |
| SECONDARY Neonatal Mortality |
0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02464917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.