About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Singleton gestation
Gestational age>=37 weeks
Spontaneous labor or induction of labor
English or spanish speaking
Disqualifiers
Preterm gestation
Major fetal anomaly
Multiple gestation
Category III fetal monitoring at time of admission
Trial design
Crossover
Treatments tested in this trial
Maternal oxygen supplementation
Other interventionMaternal oxygen supplementation 10 liters/minute via nonrebreather mask
Room air
Other interventionRoom air, no mask
Treatment groups
Trial outcomes
Primary outcomes
Percentage 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
Secondary outcomes
Perentage of patients with operative delivery (cesarean or operative vaginal delivery)
Percentage of patients with operative delivery for the indication of nonreassuring fetal status
Percentage of neonates with neonatal death
Percentage of neonates with acidemia (pH<7.1)
On delivery cord gas
Sponsors and contacts
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Washington University School of Medicine
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
University of Michigan
Collaborator
University of Texas at Austin
Collaborator
Women and Infants Hospital of Rhode Island
Collaborator
Dell Children's Medical Center of Central Texas
Collaborator
Brown University
Collaborator