CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 910 enrolled
Drug / intervention
No oxygen +1 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03581214
NCT03581214N/ACompleted

Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate

Washington University School of Medicine·interventional·Posted Jul 10, 2018·Updated Apr 15, 2025

In Brief

A clinical study evaluating No oxygen and Oxygen for Intrauterine Resuscitation. Completed, enrolled 910 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 10, 2018
Enrollment StartJul 15, 2018
Primary CompletionOct 17, 2022
Study CompletionApr 1, 2024
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 8.0 years ago

Interventions

No oxygenother

No facemask, room air only

Oxygenother

10Liters/minute oxygen by facemask