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N/A N=212 Randomized Double-blind Treatment

Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate

Intrauterine Resuscitation

Enrolled (actual)
212
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Umbilical Artery Malondialdehyde — 9.8; 10.2 umol/L

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
No oxygen (Other); Oxygen (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Washington University School of Medicine
Primary completion
Oct 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Umbilical Artery Malondialdehyde
9.8; 10.2
PRIMARY
Umbilical Artery 4-hydroxynonenal
34.1; 29.5
PRIMARY
Maternal Malondialdehyde
2.8; 2.5
PRIMARY
Maternal 4-hydroxynonenal
190.4; 168.1

Summary

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03581214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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