More than 80% of the 3 million women who labor and deliver each year in the United States undergo continuous electronic fetal monitoring (EFM) during labor in order to fetal hypoxia and prevent the transition to acidemia, expedited operative delivery, and/or neonatal morbidity. Category II EFM is the most commonly observed group of fetal heart rate features in labor. One common response to Category II EFM is maternal oxygen (O2) supplementation. The theoretic rationale for O2 administration is that it increases O2 transfer to a hypoxic fetus. There are conflicting national guidelines regarding O2 administration - the American College of Obstetricians and Gynecologists suggest O2 is ineffective, whereas the Association of Women's Health, Obstetric, and Neonatal Nurses recommend continued use given lack of definitive data on safety and efficacy. A recent national survey of nearly 600 Labor \& Delivery providers in February 2022 revealed that 49% still use O2 . Thus, there remains equipoise on the topic and high-quality data on the safety of intrapartum O2 is needed. None of the trials to date have studied the effect of intrapartum O2 on important clinical measures of neonatal or maternal morbidity. This safety data is imperative because the field of obstetrics must hold supplemental O2 to the same rigorous standards applied to any drug used in pregnancy. Without data on these definitive outcomes, it will be challenging to implement evidence-based recommendations for supplemental O2 use on Labor \& Delivery. The investigators will conduct a large, multicenter, randomized noninferiority trial of O2 supplementation versus room air in patients with Category II EFM in labor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,124
Maternal oxygen supplementation 10 liters/minute via nonrebreather mask
Room air, no mask
Barnes Jewish Hospital
St Louis, Missouri, United States
RECRUITINGPercentage of neonates meeting criteria for composite neonatal morbidity
One of the following diagnoses: Neonatal death, acidemia, meconium aspiration with pulmonary hypertension, hypoglycemia, hypoxic ischemic encephalopathy ,hypothermia treatment, seizure, respiratory distress
Time frame: Up to 28 days of life
Perentage of patients with operative delivery (cesarean or operative vaginal delivery)
Time frame: At delivery
Percentage of patients with operative delivery for the indication of nonreassuring fetal status
Time frame: At delivery
Percentage of neonates with neonatal death
Time frame: 28 days of life
Percentage of neonates with acidemia (pH<7.1)
On delivery cord gas
Time frame: At time of delivery
Percentage of neonates with meconium aspiration with pulmonary hypertension
Time frame: Within 72 hours of delivery
Percentage of neonates with hypoglycemia
Time frame: Within 24 hours of delivery
Percentage of neonates with hypoxic ischemic encephalopathy
Time frame: Within 72 hours of delivery
Percentage of neonates with hypothermia treatment
Time frame: Within 72 hours of delivery
Percentage of neonates with seizure
Time frame: 28 days of life
Percentage of neonates with respiratory distress
Time frame: Within 72 hours of delivery
umbilical artery base excess
Time frame: At delivery
umbilical artery partial pressure oxygen
Time frame: At delivery
umbilical artery partial pressure carbon dioxide
Time frame: At delivery
Percentage of patients with composite maternal morbidity
any diagnosis of the following: postpartum hemorrhage \[estimated blood loss \>1000 mL\]; severe perineal laceration, endometritis
Time frame: Within 2 weeks of delivery
Apgars at 5 and 10 minutes
Time frame: At 5 and 10 minutes of neonatal life
Apgar<5 at 5 and 10 mins
Time frame: At 5 and 10 minutes of neonatal life
Percentage of neonates with Neonatal Intensive care unit admission
Time frame: Within 72 hours of delivery
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