Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate (O2P2)

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 Overview

• Status: Completed
• Conditions: Intrauterine Resuscitation
• Intervention / Treatment: Other: No oxygen; Other: Oxygen

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nandini Raghuraman, MD MS; Phone Number: 314 273 2939; Email: nraghuraman@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Room air; Room air (no mask)	Other: No oxygen; No facemask, room air only; Other Names: Room air
Placebo Comparator: Oxygen; 10L/min Oxygen by facemask	Other: Oxygen; 10Liters/minute oxygen by facemask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Umbilical artery malondialdehyde	At delivery
Umbilical artery 4-hydroxynonenal	At delivery
Maternal malondialdehyde	Within 1 hour of delivery
Maternal 4-hydroxynonenal	Within 1 hour of delivery

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2018
• Primary Completion (Actual): October 17, 2022
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 201805045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No