Maternal Oxygen Supplementation for Intrauterine Resuscitation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorWashington University School of Medicine

About this trial

More than 80% of the 3 million women who labor and deliver each year in the United States undergo continuous electronic fetal monitoring (EFM) during labor in order to fetal hypoxia and prevent the transition to acidemia, expedited operative delivery, and/or neonatal morbidity. Category II EFM is the most commonly observed group of fetal heart rate features in labor. One common response to Category II EFM is maternal oxygen (O2) supplementation. The theoretic rationale for O2 administration is that it increases O2 transfer to a hypoxic fetus. There are conflicting national guidelines regarding O2 administration - the American College of Obstetricians and Gynecologists suggest O2 is ineffective, whereas the Association of Women's Health, Obstetric, and Neonatal Nurses recommend continued use given lack of definitive data on safety and efficacy. A recent national survey of nearly 600 Labor \& Delivery providers in February 2022 revealed that 49% still use O2 . Thus, there remains equipoise on the topic and high-quality data on the safety of intrapartum O2 is needed. None of the trials to date have studied the effect of intrapartum O2 on important clinical measures of neonatal or maternal morbidity. This safety data is imperative because the field of obstetrics must hold supplemental O2 to the same rigorous standards applied to any drug used in pregnancy. Without data on these definitive outcomes, it will be challenging to implement evidence-based recommendations for supplemental O2 use on Labor \& Delivery. The investigators will conduct a large, multicenter, randomized noninferiority trial of O2 supplementation versus room air in patients with Category II EFM in labor.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Singleton gestation

Gestational age>=37 weeks

Spontaneous labor or induction of labor

English or spanish speaking

Disqualifiers

Preterm gestation

Major fetal anomaly

Multiple gestation

Category III fetal monitoring at time of admission

Trial design

Design model

Crossover

Treatments tested in this trial

  • Maternal oxygen supplementation

    Other intervention

    Maternal oxygen supplementation 10 liters/minute via nonrebreather mask

  • Room air

    Other intervention

    Room air, no mask

Treatment groups

2,252 Participants
are divided into 2 treatment groups
Group A: OxygenOther 1 intervention
Group B: Room airActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of neonates meeting criteria for composite neonatal morbidity

One of the following diagnoses: Neonatal death, acidemia, meconium aspiration with pulmonary hypertension, hypoglycemia, hypoxic ischemic encephalopathy ,hypothermia treatment, seizure, respiratory distress

Time frame
Up to 28 days of life

Secondary outcomes

1

Perentage of patients with operative delivery (cesarean or operative vaginal delivery)

Time frame
At delivery
2

Percentage of patients with operative delivery for the indication of nonreassuring fetal status

Time frame
At delivery
3

Percentage of neonates with neonatal death

Time frame
28 days of life
4

Percentage of neonates with acidemia (pH<7.1)

On delivery cord gas

Time frame
At time of delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

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

Collaborator

University of Michigan

Collaborator

University of Texas at Austin

Collaborator

Women and Infants Hospital of Rhode Island

Collaborator

Dell Children's Medical Center of Central Texas

Collaborator

Brown University

Collaborator