Maternal Oxygen Supplementation for Intrauterine Resuscitation
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 Start (Actual) 22 May 2023
🗓️ Primary Completion (Estimated) 1 May 2027
✅ Study Completion (Estimated) 1 August 2027
👥 Enrollment (Estimated) 2124
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Saint Louis, Missouri, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 14 December 2022
  • First Submitted that Met QC Criteria 27 December 2022
  • First Posted 12 January 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 July 2024
  • Last Update Posted 10 July 2024
  • Last Verified July 2024