RecruitingNot ApplicableNCT05681624

Maternal Oxygen Supplementation for Intrauterine Resuscitation

Maternal Oxygen Supplementation for Intrauterine Resuscitation: a Multicenter Randomized Trial


Sponsor

Washington University School of Medicine

Enrollment

2,124 participants

Start Date

May 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study examines whether giving supplemental oxygen to mothers during labor when there are concerning signs on the baby's heart rate monitor (fetal heart rate decelerations) is helpful or unhelpful for the baby. You may be eligible if you: - Are pregnant with a single baby (singleton gestation) - Are at 37 weeks of pregnancy or beyond - Are in spontaneous or induced labor - Speak English or Spanish - Are having continuous fetal heart rate monitoring You may NOT be eligible if you: - Are having a preterm birth (before 37 weeks) - Have a major fetal abnormality - Are pregnant with multiples (twins, triplets, etc.) - Have Category III fetal monitoring findings on admission - Have low oxygen levels at admission (SpO2 <95%) - Are planning a scheduled cesarean section Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERMaternal oxygen supplementation

Maternal oxygen supplementation 10 liters/minute via nonrebreather mask

OTHERRoom air

Room air, no mask


Locations(1)

Barnes Jewish Hospital

St Louis, Missouri, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05681624


Related Trials