Clinical trial NCT05681624: Maternal Oxygen Supplementation for Intrauterine Resuscitation
Official title: Maternal Oxygen Supplementation for Intrauterine Resuscitation: a Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fetal Distress
Fetal Hypoxia
Labor and Delivery Complication
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Michigan
name: University of Texas at Austin
name: Women and Infants Hospital of Rhode Island
name: Dell Children's Medical Center of Central Texas
name: Brown University
First posted: 2023-01-12
Enrollment: 2124
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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: 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 Excluded from randomization if receiving nitrous oxide for analgesia at time of randomization.

Primary outcomes:
measure: Percentage of neonates meeting criteria for composite neonatal morbidity
timeFrame: Up to 28 days of life
Secondary outcomes:
measure: Perentage of patients with operative delivery (cesarean or operative vaginal delivery)
timeFrame: At delivery
measure: Percentage of patients with operative delivery for the indication of nonreassuring fetal status
timeFrame: At delivery
measure: Percentage of neonates with neonatal death
timeFrame: 28 days of life
measure: Percentage of neonates with acidemia (pH<7.1)
timeFrame: At time of delivery
measure: Percentage of neonates with meconium aspiration with pulmonary hypertension
timeFrame: Within 72 hours of delivery
measure: Percentage of neonates with hypoglycemia
timeFrame: Within 24 hours of delivery
measure: Percentage of neonates with hypoxic ischemic encephalopathy
timeFrame: Within 72 hours of delivery
measure: Percentage of neonates with hypothermia treatment
timeFrame: Within 72 hours of delivery
measure: Percentage of neonates with seizure
timeFrame: 28 days of life
measure: Percentage of neonates with respiratory distress
timeFrame: Within 72 hours of delivery
measure: umbilical artery base excess
timeFrame: At delivery
measure: umbilical artery partial pressure oxygen
timeFrame: At delivery
measure: umbilical artery partial pressure carbon dioxide
timeFrame: At delivery
measure: Percentage of patients with composite maternal morbidity
timeFrame: Within 2 weeks of delivery
measure: Apgars at 5 and 10 minutes
timeFrame: At 5 and 10 minutes of neonatal life
measure: Apgar<5 at 5 and 10 mins
timeFrame: At 5 and 10 minutes of neonatal life
measure: Percentage of neonates with Neonatal Intensive care unit admission
timeFrame: Within 72 hours of delivery
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
Study officials:
References: