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OpenTrials
Completed

NCT Number: NCT03581214

Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate

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.

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Key information

Conditions

Intrauterine Resuscitation

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No oxygen

Other

No facemask, room air only

Other names: Room air

Oxygen

Other

10Liters/minute oxygen by facemask

Primary outcomes

  1. Umbilical Artery Malondialdehyde

    Time frame: At delivery

  2. Umbilical Artery 4-hydroxynonenal

    Time frame: At delivery

  3. Maternal Malondialdehyde

    Time frame: Within 1 hour of delivery

  4. Maternal 4-hydroxynonenal

    Time frame: Within 1 hour of delivery

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: O2P2

Important dates

Study start
2018
Primary completion
2022
Study completion
2024
First posted
Jul 10, 2018
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.