Maternal Oxygen Supplementation for Intrauterine Resuscitation

NCT05681624 | Recruiting DMC

• 2 other identifiers: 202209042R01HD108614
• Study Type: interventional
• Target: 2,124
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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)

  At time of delivery

• Percentage of neonates with meconium aspiration with pulmonary hypertension

  Within 72 hours of delivery

Study Arms (2)

Oxygen

OTHER

Other: Maternal oxygen supplementation

Room air

ACTIVE COMPARATOR

Other: Room air

Interventions

Room air OTHER

Room air, no mask

Room air

Maternal oxygen supplementation OTHER

Maternal oxygen supplementation 10 liters/minute via nonrebreather mask

Oxygen

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton gestation
• Gestational age\>=37 weeks
• Spontaneous labor or induction of labor
• English or spanish speaking
• Planned continuous fetal monitoring

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Fetal Distress; Fetal Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypoxia; Signs and Symptoms, Respiratory

Central Study Contacts

Nandini Raghuraman, MD MSCI

CONTACT

3142732939; nraghuraman@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 12, 2023
• Study Start: May 22, 2023
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Upon publication of primary analysis and planned secondary analyses.

Locations

US (1)