Maternal Oxygen Use in LaborNCT02752490
The Comparative Effectiveness of Liberal Versus Restricted Maternal Administration of Oxygen During Labor
A study testing Liberal use of maternal oxygen and Indicated use of maternal oxygen in people with Maternal Oxygen Use in Labor, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The objective of this study is to determine if a strategy of indicated compared to liberal oxygen administration in labor decreases the rate of cesarean delivery. The hypothesis is that women who undergo a strategy of indicated compared to liberal oxygen administration in labor will have lower rate of cesarean… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Oxygen Use in Labor
- What is being tested?
- Liberal use of maternal oxygen and Indicated use of maternal oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 844 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 31 Jul 2016
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women with singleton gestation between 37 weeks 0 days to 42 weeks 0 days gestation who present to labor and delivery at Memorial Hermann Hospital in Houston, TX for planned labor attempt.
Who cannot join
- Lethal fetal anomaly defined as anomaly in which the fetus is unlikely to survive or the neonate is not expected to survive to initial hospital discharge
- Antepartum or intrapartum fetal demise
- Preexisting maternal conditions requiring oxygen for maternal indication, including but not limited to: Asthma that has required intubation or hospitalization in the past or currently requiring steroids (either inhaled or oral); Chronic obstructive pulmonary disease; Chronic bronchitis; Congestive heart failure/peripartum cardiomyopathy; Pneumonia; Pulmonary edema; Pulmonary embolus
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Memorial Hermann Hospital
Houston, Texas, 77030
About this study
Official title: The Comparative Effectiveness of Liberal Versus Restricted Maternal Administration of Oxygen During Labor: a Controlled Before and After Study
The objective of this study is to determine if a strategy of indicated compared to liberal oxygen administration in labor decreases the rate of cesarean delivery. The hypothesis is that women who undergo a strategy of indicated compared to liberal oxygen administration in labor will have lower rate of cesarean delivery and fetal acidemia at birth.
Read the detailed description
This is a single-site before and after study comparing the strategy of liberal versus indicated use of maternal oxygen in the first and second stages of labor in the setting of a category 2 fetal heart rate tracing (FHR) tracing, as defined by American Congress of Obstetrics and Gynecology (ACOG) and National Institute of Child Health and Human Development (NICHD) guidelines. All patients who are at term and are undergoing labor at Memorial Hermann Hospital in Houston, Texas during the time frame of the study will be included in the study. The study will be conducted over 18 weeks. It will involve two 8 week time periods during which all patients will under either a strategy of liberal administration of oxygen use (current practice) in the "before" portion of the study and indicated administration of oxygen in the "after" portion of the study (new practice). There will be a transition period where training, education, and audit + feedback will be done to prepare for a strategy of indicated administration of oxygen.
- Conditions
- Maternal Oxygen Use in Labor
- Being tested
- Liberal use of maternal oxygen, Indicated use of maternal oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberal use of maternal oxygenDrug
Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by ACOG10 at the discretion of the primary nurse or physician
Indicated use of maternal oxygenDrug
Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
| Study group | Role | What they receive |
|---|---|---|
| Liberal use of maternal oxygen | Active comparator | Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician Receives: Drug: Liberal use of maternal oxygen |
| Indicated use of maternal oxygen | Experimental | Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur. Receives: Drug: Indicated use of maternal oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Delivered by Cesarean
Measured: at time of birth
Secondary outcomes (7)
Number of Participants With Umbilical Artery pH (Potential Hydrogen) < 7.10 at Birth
Measured: at time of birth
Number of Participants Who Delivered by Cesarean for Non-reassuring Fetal Status
Measured: at time of birth
Number of Participants Whose Infants Had an Apgar Score < 7 at 5 Minutes
The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. A score of 10 is very unusual, since almost all newborns lose 1 point for blue hands and feet, which is normal for after birth.
Measured: 5 minutes after birth
Number of Participants Whose Infants Were Admitted to the Neonatal Intensive Care Unit (NICU)
Measured: from time of birth to discharge from hospital (an average of 2-4 days)
Total Duration of Maternal Oxygen Use
Measured: during labor
Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen
"Intrauterine resuscitation" includes administration of terbutaline, amnioinfusion, cessation of oxytocin, and intravenous (IV) fluid boluses. In this measure, the number of participants who received any of these 5 procedures will be reported in aggregate as the "number of participants who received intrauterine resuscitation other than administration of maternal oxygen."
Measured: during labor
Number of Participants With Clinical Chorioamnionitis
Measured: during labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion31 Jul 2016
- Study completion31 Jul 2016
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 Maternal Oxygen Use in LaborStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 844 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nanaama Ankumah Bentum, The University of Texas Health Science Center, Houston
- Investigators
- Nana-Ama E Ankumah, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752490
- Sponsor's protocol ID
- HSC-MS-16-0142
- Status last verified
- Oct 2020
- First submitted
- 20 Apr 2016
- Last updated
- 12 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Effectiveness of Liberal Versus Restricted Maternal Administration of Oxygen During Labor: a Controlled Before and After Study
- ClinicalTrials.gov ID
- NCT02752490
- Acronym / sponsor ID
- HSC-MS-16-0142
- Conditions
- Maternal Oxygen Use in Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 844 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Posted 2 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine if a strategy of indicated compared to liberal oxygen administration in labor decreases the rate of cesarean delivery. The hypothesis is that women who undergo a strategy of indicated compared to liberal oxygen administration in labor will have lower rate of cesarean delivery and fetal acidemia at birth.
Detailed description
This is a single-site before and after study comparing the strategy of liberal versus indicated use of maternal oxygen in the first and second stages of labor in the setting of a category 2 fetal heart rate tracing (FHR) tracing, as defined by American Congress of Obstetrics and Gynecology (ACOG) and National Institute of Child Health and Human Development (NICHD) guidelines. All patients who are at term and are undergoing labor at Memorial Hermann Hospital in Houston, Texas during the time frame of the study will be included in the study. The study will be conducted over 18 weeks. It will involve two 8 week time periods during which all patients will under either a strategy of liberal administration of oxygen use (current practice) in the "before" portion of the study and indicated administration of oxygen in the "after" portion of the study (new practice). There will be a transition period where training, education, and audit + feedback will be done to prepare for a strategy of indicated administration of oxygen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal use of maternal oxygen | Active comparator | Drug: Liberal use of maternal oxygenAdministration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician |
| Indicated use of maternal oxygen | Experimental | Drug: Indicated use of maternal oxygenAdministration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women with singleton gestation between 37 weeks 0 days to 42 weeks 0 days gestation who present to labor and delivery at Memorial Hermann Hospital in Houston, TX for planned labor attempt.
Key exclusion criteria (3 listed)
- Lethal fetal anomaly defined as anomaly in which the fetus is unlikely to survive or the neonate is not expected to survive to initial hospital discharge
- Antepartum or intrapartum fetal demise
- Preexisting maternal conditions requiring oxygen for maternal indication, including but not limited to: Asthma that has required intubation or hospitalization in the past or currently requiring steroids (either inhaled or oral); Chronic obstructive pulmonary disease; Chronic bronchitis; Congestive heart failure/peripartum cardiomyopathy; Pneumonia; Pulmonary edema; Pulmonary embolus
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 |
|---|---|---|
| Liberal use of maternal oxygenAdministration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by ACOG10 at the discretion of the primary nurse or physician | Drug | Liberal use of maternal oxygen |
| Indicated use of maternal oxygenAdministration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur. | Drug | Indicated use of maternal oxygen |
Primary outcome
Number of Participants Who Delivered by Cesarean
Time frame: at time of birth
7 secondary outcomes
Number of Participants With Umbilical Artery pH (Potential Hydrogen) < 7.10 at Birth
Time frame: at time of birth
Number of Participants Who Delivered by Cesarean for Non-reassuring Fetal Status
Time frame: at time of birth
Number of Participants Whose Infants Had an Apgar Score < 7 at 5 Minutes
Time frame: 5 minutes after birth
Number of Participants Whose Infants Were Admitted to the Neonatal Intensive Care Unit (NICU)
Time frame: from time of birth to discharge from hospital (an average of 2-4 days)
Total Duration of Maternal Oxygen Use
Time frame: during labor
Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen
Time frame: during labor
Number of Participants With Clinical Chorioamnionitis
Time frame: during labor
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Nana-Ama E Ankumah, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liberal use of maternal oxygen and Indicated use of maternal oxygen in people with Maternal Oxygen Use in Labor, run by The University of Texas Health Science Center, Houston 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 1 inclusion and 3 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 12 Oct 2020. 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 2 Mar 2018). 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?
Number of Participants Who Delivered by Cesarean (time frame: at time of birth). 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 12 Oct 2020.