Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

910 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-15

Study Completion Date

2024-04-01

Brief Summary

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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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Detailed Description

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Conditions

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Intrauterine Resuscitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Room air

Room air (no mask)

Group Type ACTIVE_COMPARATOR

No oxygen

Intervention Type OTHER

No facemask, room air only

Oxygen

10L/min Oxygen by facemask

Group Type PLACEBO_COMPARATOR

Oxygen

Intervention Type OTHER

10Liters/minute oxygen by facemask

Interventions

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No oxygen

No facemask, room air only

Intervention Type OTHER

Oxygen

10Liters/minute oxygen by facemask

Intervention Type OTHER

Other Intervention Names

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Room air

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes