Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate

Overview

Approximately 2/3 of laboring women receive supplemental oxygen (O2) in an attempt to reverse perceived fetal hypoxia on electronic fetal monitoring (EFM). O2 supplementation is most commonly used in patients with Category II EFM, a class of EFM patterns designed in part to identify fetal acidemia. This liberal use of O2 in laboring patients is concerning because hyperoxygenation in infants is associated with adverse outcomes including retinopathy and abnormal neurodevelopment. Furthermore, excess O2 exposure is linked to free radical generation and subsequent oxidative cell damage. This calls for a closer look at the safety of intrauterine O2 exposure. The proposed project explores potential mechanisms for harm with maternal O2 supplementation in laboring patients with Category II EFM. Specifically, this project will determine the effect of O2, compared to room air (RA), on umbilical cord and maternal levels of malondialdehyde (MDA) and 4-hydroxynonenal (4-HNE), markers of free radical-induced oxidative stress. The study will also explore the correlation between urinary and blood markers of oxidative stress. Banked specimens will be used to investigate the potential effect of peripartum O2 exposure on placental oxidative stress in the future.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 17, 2022

Interventions

  • Other: No oxygen
    • No facemask, room air only
  • Other: Oxygen
    • 10Liters/minute oxygen by facemask

Arms, Groups and Cohorts

  • Active Comparator: Room air
    • Room air (no mask)
  • Placebo Comparator: Oxygen
    • 10L/min Oxygen by facemask

Clinical Trial Outcome Measures

Primary Measures

  • Umbilical artery malondialdehyde
    • Time Frame: At delivery
  • Umbilical artery 4-hydroxynonenal
    • Time Frame: At delivery
  • Maternal malondialdehyde
    • Time Frame: Within 1 hour of delivery
  • Maternal 4-hydroxynonenal
    • Time Frame: Within 1 hour of delivery

Participating in This Clinical Trial

Inclusion Criteria

  • Singleton – Gestational age ≥37 weeks – Spontaneous labor or induction of labor – English speaking – Ability to give informed consent Exclusion Criteria:

  • Major fetal anomaly – Multiple gestation – Category III electronic fetal monitoring – Maternal hypoxia – Preeclampsia – Intrauterine growth restriction – Pregestational diabetes – Tobacco use

Gender Eligibility: Female

This study is in pregnant females only

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nandini Raghuraman, Assistant Professor – Washington University School of Medicine

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