Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liberal use of maternal oxygen | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Delivered by Cesarean | at time of birth |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Umbilical Artery pH (Potential Hydrogen) < 7.10 at Birth | at time of birth | |
| Number of Participants Who Delivered by Cesarean for Non-reassuring Fetal Status | at time of birth |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nana-Ama E Ankumah, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Indicated Use of Maternal Oxygen |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Indicated use of maternal oxygen | Drug | 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. |
|
| 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. | 5 minutes after birth |
| Number of Participants Whose Infants Were Admitted to the Neonatal Intensive Care Unit (NICU) | from time of birth to discharge from hospital (an average of 2-4 days) |
| Total Duration of Maternal Oxygen Use | 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." | during labor |
| Number of Participants With Clinical Chorioamnionitis | during labor |
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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Delivered by Cesarean | Posted | Count of Participants | Participants | at time of birth |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Umbilical Artery pH (Potential Hydrogen) < 7.10 at Birth | For this outcome measure, the number of participants analyzed is not equal to the number of participants who started or completed the study because each participant's provider determines whether umbilical artery pH is analyzed, and thus, umbilical artery pH is not collected for every participant in the study. | Posted | Count of Participants | Participants | at time of birth |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Delivered by Cesarean for Non-reassuring Fetal Status | Posted | Count of Participants | Participants | at time of birth |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | 5 minutes after birth |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Whose Infants Were Admitted to the Neonatal Intensive Care Unit (NICU) | Posted | Count of Participants | Participants | from time of birth to discharge from hospital (an average of 2-4 days) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Total Duration of Maternal Oxygen Use | For this outcome measure, the number of participants analyzed is not equal to the number of participants who started or completed the study because not all participants received oxygen. All who received oxygen were analyzed for this measure. | Posted | Median | Inter-Quartile Range | minutes | during labor |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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." | Posted | Count of Participants | Participants | during labor |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinical Chorioamnionitis | Posted | Count of Participants | Participants | during labor |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 409 | 0 | 409 | ||
| EG001 | 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. | 0 | 435 | 0 | 435 |
Not provided
Not provided
This was a non-randomized trial, and was performed in a single institution, which may reduce its generalizability.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nana-Ama E Ankumah, MD | The University of Texas Health Science Center at Houston | 713-500-6421 | Nana.Ama.E.Ankumah@uth.tmc.edu |
| Male |
|
| Counts |
|---|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|