Maternal Oxygen Supplementation for Intrauterine Resuscitation

Study Overview
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Brief Summary
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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.

Official Title
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Maternal Oxygen Supplementation for Intrauterine Resuscitation: a Multicenter Randomized Trial

Conditions
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Fetal Distress, Fetal Hypoxia, Labor and Delivery Complication

Intervention / Treatment
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* Other: Maternal oxygen supplementation
* Other: Room air


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton gestation Gestational age>=37 weeks Spontaneous labor or induction of labor English or spanish speaking Planned continuous fetal monitoring Exclusion Criteria: Preterm gestation Major fetal anomaly Multiple gestation Category III fetal monitoring at time of admission Maternal hypoxia <95% Planned or scheduled cesarean delivery
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Oxygen<br> | Other: Maternal oxygen supplementation<br>* Maternal oxygen supplementation 10 liters/minute via nonrebreather mask<br>|
| Active Comparator: Room air<br> | Other: Room air<br>* Room air, no mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 28 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perentage of patients with operative delivery (cesarean or operative vaginal delivery) |  | At delivery | 
| Percentage of patients with operative delivery for the indication of nonreassuring fetal status |  | At delivery | 
| Percentage of neonates with neonatal death |  | 28 days of life | 
| Percentage of neonates with acidemia (pH<7.1) | On delivery cord gas | At time of delivery | 
| Percentage of neonates with meconium aspiration with pulmonary hypertension |  | Within 72 hours of delivery | 
| Percentage of neonates with hypoglycemia |  | Within 24 hours of delivery | 
| Percentage of neonates with hypoxic ischemic encephalopathy |  | Within 72 hours of delivery | 
| Percentage of neonates with hypothermia treatment |  | Within 72 hours of delivery | 
| Percentage of neonates with seizure |  | 28 days of life | 
| Percentage of neonates with respiratory distress |  | Within 72 hours of delivery | 
| umbilical artery base excess |  | At delivery | 
| umbilical artery partial pressure oxygen |  | At delivery | 
| umbilical artery partial pressure carbon dioxide |  | 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 | Within 2 weeks of delivery | 
| Apgars at 5 and 10 minutes |  | At 5 and 10 minutes of neonatal life | 
| Apgar<5 at 5 and 10 mins |  | At 5 and 10 minutes of neonatal life | 
| Percentage of neonates with Neonatal Intensive care unit admission |  | Within 72 hours of delivery |