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Maternal Oxygen Supplementation for Intrauterine Resuscitation

Maternal Oxygen Supplementation for Intrauterine Resuscitation: a Multicenter Randomized Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05681624
Acronym
MOXY
Enrollment
2124
Registered
2023-01-12
Start date
2023-05-22
Completion date
2028-12-31
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Distress, Fetal Hypoxia, Labor and Delivery Complication

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.

Interventions

OTHERMaternal oxygen supplementation

Maternal oxygen supplementation 10 liters/minute via nonrebreather mask

Room air, no mask

Sponsors

Washington University School of Medicine
Lead SponsorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Michigan
CollaboratorOTHER
University of Texas at Austin
CollaboratorOTHER
Women and Infants Hospital of Rhode Island
CollaboratorOTHER
Dell Children's Medical Center of Central Texas
CollaboratorOTHER
Brown University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of neonates meeting criteria for composite neonatal morbidityUp to 28 days of lifeOne of the following diagnoses: Neonatal death, acidemia, meconium aspiration with pulmonary hypertension, hypoglycemia, hypoxic ischemic encephalopathy ,hypothermia treatment, seizure, respiratory distress

Secondary

MeasureTime frameDescription
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 statusAt delivery
Percentage of neonates with neonatal death28 days of life
Percentage of neonates with acidemia (pH<7.1)At time of deliveryOn delivery cord gas
Percentage of neonates with meconium aspiration with pulmonary hypertensionWithin 72 hours of delivery
Percentage of neonates with hypoglycemiaWithin 24 hours of delivery
Percentage of neonates with hypoxic ischemic encephalopathyWithin 72 hours of delivery
Percentage of neonates with hypothermia treatmentWithin 72 hours of delivery
Percentage of neonates with seizure28 days of life
Percentage of neonates with respiratory distressWithin 72 hours of delivery
umbilical artery base excessAt delivery
umbilical artery partial pressure oxygenAt delivery
Percentage of patients with composite maternal morbidityWithin 2 weeks of deliveryany diagnosis of the following: postpartum hemorrhage \[estimated blood loss \>1000 mL\]; severe perineal laceration, endometritis
Apgars at 5 and 10 minutesAt 5 and 10 minutes of neonatal life
Apgar<5 at 5 and 10 minsAt 5 and 10 minutes of neonatal life
umbilical artery partial pressure carbon dioxideAt delivery
Percentage of neonates with Neonatal Intensive care unit admissionWithin 72 hours of delivery

Countries

United States

Contacts

CONTACTNandini Raghuraman, MD MSCI
nraghuraman@wustl.edu3142732939

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026