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

The Washington University

Status: Completed

Conditions: Intrauterine Resuscitation

Treatments: Other: Oxygen; Other: No oxygen

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03581214

201805045

1K23HD098315-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 910 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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910 participants in 2 patient groups, including a placebo group

Room air

Active Comparator group

Description:

Room air (no mask)

Treatment:

Other: No oxygen

Oxygen

Placebo Comparator group

Description:

10L/min Oxygen by facemask

Treatment:

Other: Oxygen