Trial Outcomes & Findings for The Comparative Effectiveness of Liberal Versus Restricted Maternal Administration of Oxygen During Labor (NCT NCT02752490)
NCT ID: NCT02752490
Last Updated: 2020-10-12
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
844 participants
Primary outcome timeframe
at time of birth
Results posted on
2020-10-12
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
409
|
435
|
|
Overall Study
COMPLETED
|
409
|
435
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Comparative Effectiveness of Liberal Versus Restricted Maternal Administration of Oxygen During Labor
Baseline characteristics by cohort
| Measure |
Liberal Use of Maternal Oxygen
n=409 Participants
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
n=435 Participants
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.
|
Total
n=844 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.7 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
27.7 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
27.7 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
409 Participants
n=5 Participants
|
435 Participants
n=7 Participants
|
844 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
409 Participants
n=5 Participants
|
435 Participants
n=7 Participants
|
844 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at time of birthOutcome measures
| Measure |
Liberal Use of Maternal Oxygen
n=409 Participants
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
n=435 Participants
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.
|
|---|---|---|
|
Number of Participants Who Delivered by Cesarean
|
83 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: at time of birthPopulation: 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.
Outcome measures
| Measure |
Liberal Use of Maternal Oxygen
n=227 Participants
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
n=243 Participants
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.
|
|---|---|---|
|
Number of Participants With Umbilical Artery pH (Potential Hydrogen) < 7.10 at Birth
|
7 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: at time of birthOutcome measures
| Measure |
Liberal Use of Maternal Oxygen
n=83 Participants
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
n=75 Participants
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.
|
|---|---|---|
|
Number of Participants Who Delivered by Cesarean for Non-reassuring Fetal Status
|
37 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 5 minutes after birthThe 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.
Outcome measures
| Measure |
Liberal Use of Maternal Oxygen
n=409 Participants
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
n=435 Participants
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.
|
|---|---|---|
|
Number of Participants Whose Infants Had an Apgar Score < 7 at 5 Minutes
|
4 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: from time of birth to discharge from hospital (an average of 2-4 days)Outcome measures
| Measure |
Liberal Use of Maternal Oxygen
n=409 Participants
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
n=435 Participants
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.
|
|---|---|---|
|
Number of Participants Whose Infants Were Admitted to the Neonatal Intensive Care Unit (NICU)
|
38 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: during laborPopulation: 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.
Outcome measures
| Measure |
Liberal Use of Maternal Oxygen
n=217 Participants
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
n=216 Participants
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.
|
|---|---|---|
|
Total Duration of Maternal Oxygen Use
|
89 minutes
Interval 42.0 to 172.0
|
87 minutes
Interval 36.0 to 152.0
|
SECONDARY outcome
Timeframe: 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."
Outcome measures
| Measure |
Liberal Use of Maternal Oxygen
n=409 Participants
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
n=435 Participants
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.
|
|---|---|---|
|
Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen
Administration of intravenous fluid bolus
|
240 Participants
|
236 Participants
|
|
Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen
Cessation of oxytocin
|
121 Participants
|
118 Participants
|
|
Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen
Amnioinfusion
|
13 Participants
|
11 Participants
|
|
Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen
Administration of terbutaline
|
18 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: during laborOutcome measures
| Measure |
Liberal Use of Maternal Oxygen
n=409 Participants
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
n=435 Participants
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.
|
|---|---|---|
|
Number of Participants With Clinical Chorioamnionitis
|
16 Participants
|
14 Participants
|
Adverse Events
Liberal Use of Maternal Oxygen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Indicated Use of Maternal Oxygen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nana-Ama E Ankumah, MD
The University of Texas Health Science Center at Houston
Phone: 713-500-6421
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place