Maternal Oxygen Supplementation for Intrauterine Resuscitation

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05681624
Status
Recruiting
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Conditions

  • Fetal Distress
  • Fetal Hypoxia
  • Labor and Delivery Complication

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Maternal oxygen supplementation — OTHER
    Maternal oxygen supplementation 10 liters/minute via nonrebreather mask
  • Room air — OTHER
    Room air, no mask

Study Details

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.

Key Dates

Start date
May 22, 2023
Status verified
Feb 2026
Primary completion
Feb 28, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
2,124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Other: Oxygen
  • Active Comparator: Room air

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Barnes Jewish HospitalSt LouisMissouri63110
Nandini Raghuraman, MD MS

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By research site
Barnes Jewish Hospital· St Louis, MO

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