Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate

Not Applicable

Completed

• Conditions: Intrauterine Resuscitation
• Interventions: Other: Oxygen; Other: No oxygen

• Registration Number: NCT03581214
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-07-10
• Study Start: 2018-07-15
• Primary Completion: 2022-10-17
• Status Verified: 2024-04
• Study Completion: 2024-04-01
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 212

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oxygen	Oxygen	10L/min Oxygen by facemask
Room air	No oxygen	Room air (no mask)

Primary Outcome Measures

Name	Time	Method
Maternal 4-hydroxynonenal	Within 1 hour of delivery
Umbilical artery 4-hydroxynonenal	At delivery
Umbilical artery malondialdehyde	At delivery
Maternal malondialdehyde	Within 1 hour of delivery

Trial Locations

Locations (1)

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States