Children's Memorial Hermann Hospital
Houston, Texas, 77030, United States
NCT Number: NCT02752490
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: at time of birth
Time frame: at time of birth
Time frame: at time of birth
Time frame: 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.
Time frame: from time of birth to discharge from hospital (an average of 2-4 days)
Time frame: during labor
Time frame: 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."
Time frame: during labor
The University of Texas Health Science Center, Houston
Other
The Comparative Effectiveness of Liberal Versus Restricted Maternal Administration of Oxygen During Labor: a Controlled Before and After Study
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