Maternal Oxygen Use in Labor
Conditions
Brief 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 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.
Interventions
DRUGLiberal 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 ACOG10 at the discretion of the primary nurse or physician
DRUGIndicated use of maternal oxygen
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Delivered by Cesarean | at time of birth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Delivered by Cesarean for Non-reassuring Fetal Status | at time of birth | — |
| Number of Participants Whose Infants Had an Apgar Score < 7 at 5 Minutes | 5 minutes after birth | 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. |
| 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) | — |
| Number of Participants With Umbilical Artery pH (Potential Hydrogen) < 7.10 at Birth | at time of birth | — |
| Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen | during labor | 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. |
| Number of Participants With Clinical Chorioamnionitis | during labor | — |
| Total Duration of Maternal Oxygen Use | during labor | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 409 |
| 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. | 435 |
| Total | 844 |
Baseline characteristics
| Characteristic | Liberal Use of Maternal Oxygen | Indicated Use of Maternal Oxygen | Total |
|---|---|---|---|
| Age, Continuous | 27.7 years STANDARD_DEVIATION 5.6 | 27.7 years STANDARD_DEVIATION 5.6 | 27.7 years STANDARD_DEVIATION 5.6 |
| Region of Enrollment United States | 409 Participants | 435 Participants | 844 Participants |
| Sex: Female, Male Female | 409 Participants | 435 Participants | 844 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 409 | 0 / 435 |
| serious Total, serious adverse events | 0 / 409 | 0 / 435 |
Outcome results
Primary
Number of Participants Who Delivered by Cesarean
Time frame: at time of birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Use of Maternal Oxygen | Number of Participants Who Delivered by Cesarean | 83 Participants |
| Indicated Use of Maternal Oxygen | Number of Participants Who Delivered by Cesarean | 75 Participants |
Secondary
Number of Participants Who Delivered by Cesarean for Non-reassuring Fetal Status
Time frame: at time of birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Use of Maternal Oxygen | Number of Participants Who Delivered by Cesarean for Non-reassuring Fetal Status | 37 Participants |
| Indicated Use of Maternal Oxygen | Number of Participants Who Delivered by Cesarean for Non-reassuring Fetal Status | 39 Participants |
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.
Time frame: during labor
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liberal Use of Maternal Oxygen | Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen | Administration of intravenous fluid bolus | 240 Participants |
| Liberal Use of Maternal Oxygen | Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen | Cessation of oxytocin | 121 Participants |
| Liberal Use of Maternal Oxygen | Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen | Amnioinfusion | 13 Participants |
| Liberal Use of Maternal Oxygen | Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen | Administration of terbutaline | 18 Participants |
| Indicated Use of Maternal Oxygen | Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen | Administration of terbutaline | 23 Participants |
| Indicated Use of Maternal Oxygen | Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen | Administration of intravenous fluid bolus | 236 Participants |
| Indicated Use of Maternal Oxygen | Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen | Amnioinfusion | 11 Participants |
| Indicated Use of Maternal Oxygen | Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen | Cessation of oxytocin | 118 Participants |
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.
Time frame: 5 minutes after birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Use of Maternal Oxygen | Number of Participants Whose Infants Had an Apgar Score < 7 at 5 Minutes | 4 Participants |
| Indicated Use of Maternal Oxygen | Number of Participants Whose Infants Had an Apgar Score < 7 at 5 Minutes | 13 Participants |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Use of Maternal Oxygen | Number of Participants Whose Infants Were Admitted to the Neonatal Intensive Care Unit (NICU) | 38 Participants |
| Indicated Use of Maternal Oxygen | Number of Participants Whose Infants Were Admitted to the Neonatal Intensive Care Unit (NICU) | 42 Participants |
Secondary
Number of Participants With Clinical Chorioamnionitis
Time frame: during labor
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Use of Maternal Oxygen | Number of Participants With Clinical Chorioamnionitis | 16 Participants |
| Indicated Use of Maternal Oxygen | Number of Participants With Clinical Chorioamnionitis | 14 Participants |
Secondary
Number of Participants With Umbilical Artery pH (Potential Hydrogen) < 7.10 at Birth
Time frame: at time of birth
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Use of Maternal Oxygen | Number of Participants With Umbilical Artery pH (Potential Hydrogen) < 7.10 at Birth | 7 Participants |
| Indicated Use of Maternal Oxygen | Number of Participants With Umbilical Artery pH (Potential Hydrogen) < 7.10 at Birth | 12 Participants |
Secondary
Total Duration of Maternal Oxygen Use
Time frame: during labor
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liberal Use of Maternal Oxygen | Total Duration of Maternal Oxygen Use | 89 minutes |
| Indicated Use of Maternal Oxygen | Total Duration of Maternal Oxygen Use | 87 minutes |