- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02752490
The Comparative Effectiveness of Liberal Versus Restricted Maternal Administration of Oxygen During Labor
October 8, 2020 updated by: Nanaama Ankumah Bentum, The University of Texas Health Science Center, Houston
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
844
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Children's Memorial Hermann Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Liberal use of maternal oxygen
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
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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
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Experimental: Indicated use of maternal oxygen
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants Who Delivered by Cesarean
Time Frame: at time of birth
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at time of birth
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Umbilical Artery pH (Potential Hydrogen) < 7.10 at Birth
Time Frame: at time of birth
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at time of birth
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Number of Participants Who Delivered by Cesarean for Non-reassuring Fetal Status
Time Frame: at time of birth
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at time of birth
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Number of Participants Whose Infants Had an Apgar Score < 7 at 5 Minutes
Time Frame: 5 minutes after birth
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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.
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5 minutes after birth
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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)
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from time of birth to discharge from hospital (an average of 2-4 days)
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Total Duration of Maternal Oxygen Use
Time Frame: during labor
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during labor
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Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen
Time Frame: during labor
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"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."
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during labor
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Number of Participants With Clinical Chorioamnionitis
Time Frame: during labor
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during labor
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nana-Ama E Ankumah, MD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Actual)
July 31, 2016
Study Completion (Actual)
July 31, 2016
Study Registration Dates
First Submitted
April 20, 2016
First Submitted That Met QC Criteria
April 23, 2016
First Posted (Estimate)
April 27, 2016
Study Record Updates
Last Update Posted (Actual)
October 12, 2020
Last Update Submitted That Met QC Criteria
October 8, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- HSC-MS-16-0142
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Hospital MerkurCompletedInduction of Labor Affected Fetus / Newborn | Prostaglandins Causing Adverse Effects in Therapeutic UseCroatia
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University Hospital, GenevaSwiss National Science Foundation; University of Applied Sciences of Western...CompletedDystocia | Maternal Distress in Labor | Persistent Occipitoposterior or Occipitoanterior Position | Fetal Position and Presentation AbnormalitiesSwitzerland
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Vapotherm, Inc.Oxford University Hospitals NHS Trust; Ashford and St. Peter's Hospitals NHS...CompletedOxygen Titration in Preterm Infants to Manage Lung DiseaseUnited Kingdom
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RTI InternationalMedical Research Council, South AfricaCompletedMaternal; Alcohol Use, Affecting FetusSouth Africa
Clinical Trials on Liberal use of maternal oxygen
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Rigshospitalet, DenmarkCompletedWounds and Injuries | TraumaDenmark
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Medical University InnsbruckCompletedThoracic Surgery | Mechanical Ventilation | One-Lung VentilationAustria
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The Hospital for Sick ChildrenRecruitingHypoplastic Left Heart SyndromeCanada
-
Baylor College of MedicineActive, not recruiting
-
University of WashingtonRecruitingNeurodevelopmental Disorders | PrematurityMalawi
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Washington University School of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingFetal Hypoxia | Fetal Distress | Labor and Delivery ComplicationUnited States
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Rigshospitalet, DenmarkThe Novo Nordic FoundationActive, not recruitingWounds and Injuries | Trauma | Oxygen ToxicityDenmark, Switzerland, Netherlands
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Stanford UniversityCompletedVentilatory Depression | Postoperative Respiratory ComplicationUnited States
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Centre Hospitalier Intercommunal de Toulon La Seyne...Completed
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Saint Thomas Hospital, PanamaCompletedSurgical Wound InfectionPanama