Recruiting

Oxygen Supplementation

Sponsor:

Washington University School of Medicine

Code:

NCT05681624

Conditions

Fetal Distress

Fetal Hypoxia

Labor and Delivery Complication

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

Maternal oxygen supplementation

Room air

Study Details

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.

Conditions

Fetal Distress

Fetal Hypoxia

Labor and Delivery Complication

Study ID

NCT05681624

Start date

May 22, 2023

Status verified date

Aug, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

2252 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Oxygen

active comparator: Room air

Interventions

Maternal oxygen supplementation

Maternal oxygen supplementation 10 liters/minute via nonrebreather mask

Room air

Room air, no mask

Primary outcome measure

  • Percentage of neonates meeting criteria for composite neonatal morbidity [ Time Frame: Up to 28 days of life ]

Central Contacts and Locations

Central contacts

Nandini Raghuraman, MD MSCI

3142732939nraghuraman@wustl.edu

Locations

Barnes Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

More Information

Sponsor

Washington University School of Medicine

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-08-10.