Cesarean SectionSOSNCT02464917
Supplemental Oxygen Study
A study testing Device: simple facemask to administer supplemental oxygen in people with Cesarean Section and Supplemental Oxygen, run by MemorialCare Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section, Supplemental Oxygen, Umbilical Cord Gases
- What is being tested?
- Device: simple facemask to administer supplemental oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Scheduled cesarean section
- Singleton
- Term gestation
Who cannot join
- Maternal lung disease including asthma
- Evidence of hypoxemia prior to enrollment
- Intrauterine growth restriction
- Chronic hypertension
- Preeclampsia
- Fetal anomalies
- Breech position
- Multiple gestation
Trial locations and contacts
1 site in 1 country.
United States1 site
Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital
Long Beach, California, 90806
About this 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.
Read the 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.
- Conditions
- Cesarean Section, Supplemental Oxygen, Umbilical Cord Gases
- Being tested
- Device: simple facemask to administer supplemental oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: simple facemask to administer supplemental oxygenDevice
| Study group | Role | What they receive |
|---|---|---|
| Supplemental oxygen | Experimental | Subjects in this arm will receive 10L/min via simple facemask Receives: Device: Device: simple facemask to administer supplemental oxygen |
| Room air | No intervention | This control arm will receive no supplemental oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical Cord pH Levels
marker for metabolic acidosis
Measured: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
Secondary outcomes (10)
Umbilical Cord Base Excess
marker for metabolic acidosis
Measured: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
Umbilical Cord Partial Pressure Carbon Dioxide (pCO2)
marker for metabolic acidosis
Measured: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
Umbilical Cord Bicarbonate (HCO3)
marker for metabolic acidosis
Measured: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
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)
Measured: completed at 5 minutes of life, Apgar <7
Number of Newborns With Respiratory Distress Syndrome
syndrome typically affecting premature babies due to immature lung maturation or development
Measured: completed once infant is discharged home; anticipate 1-4 days
Number of Newborns With Necrotizing Enterocolitis
condition that affects newborn bowels where the tissue undergoes necrosis
Measured: completed once infant is discharged home; anticipate 1-4 days
Number of Newborns With Intraventricular Hemorrhage
condition that causes bleeding within the brain typically affecting premature babies
Measured: completed once infant is discharged home; anticipate 1-4 days
Number of Newborns Requiring Intubation
needing supplemental oxygen for the newborn through breathing device
Measured: completed once infant is discharged home; anticipate 1-4 days
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.
Measured: completed once infant is discharged home; anticipate 1-4 days
Neonatal Mortality
Measured: completed once infant is discharged home; anticipate 1-4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- MemorialCare Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Nageotte, MemorialCare Health System
- Investigators
- Michael Nageotte, MD, Principal investigator, MemorialCare Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464917
- Sponsor's protocol ID
- 491-14
- Acronym
- SOS
- Status last verified
- Aug 2019
- First submitted
- 2 Jun 2015
- Last updated
- 22 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Oxygen Study
- ClinicalTrials.gov ID
- NCT02464917
- Acronym / sponsor ID
- SOS / 491-14
- Conditions
- Cesarean Section, Supplemental Oxygen, Umbilical Cord Gases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- MemorialCare Health SystemUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Posted 22 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemental oxygen | Experimental | Device: Device: simple facemask to administer supplemental oxygenSubjects in this arm will receive 10L/min via simple facemask |
| Room air | No intervention | –This control arm will receive no supplemental oxygen |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Scheduled cesarean section
- Singleton
- Term gestation
Key exclusion criteria (8 listed)
- Maternal lung disease including asthma
- Evidence of hypoxemia prior to enrollment
- Intrauterine growth restriction
- Chronic hypertension
- Preeclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: simple facemask to administer supplemental oxygen | Device | Supplemental oxygen |
Primary outcome
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
10 secondary outcomes
Umbilical Cord Base Excess
Time frame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
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
Umbilical Cord Bicarbonate (HCO3)
Time frame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
Number of Newborns With an Apgar Score <7
Time frame: completed at 5 minutes of life, Apgar <7
Number of Newborns With Respiratory Distress Syndrome
Time frame: completed once infant is discharged home; anticipate 1-4 days
Number of Newborns With Necrotizing Enterocolitis
Time frame: completed once infant is discharged home; anticipate 1-4 days
Number of Newborns With Intraventricular Hemorrhage
Time frame: completed once infant is discharged home; anticipate 1-4 days
Number of Newborns Requiring Intubation
Time frame: completed once infant is discharged home; anticipate 1-4 days
Number of Newborns Admitted to the NICU (Neonatal Intensive Care Unit)
Time frame: completed once infant is discharged home; anticipate 1-4 days
Neonatal Mortality
Time frame: completed once infant is discharged home; anticipate 1-4 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Nageotte, MD principal investigator
MemorialCare Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: simple facemask to administer supplemental oxygen in people with Cesarean Section and Supplemental Oxygen, run by MemorialCare Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Umbilical Cord pH Levels (time frame: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.