Maternal Oxygen Supplementation for Intrauterine Resuscitation: a Multicenter Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Healthy Volunteers: t
View:

• Singleton gestation

• Gestational age\>=37 weeks

• Spontaneous labor or induction of labor

• English or spanish speaking

• Planned continuous fetal monitoring

Locations
United States
Missouri
Barnes Jewish Hospital
RECRUITING
St Louis
Contact Information
Primary
Nandini Raghuraman, MD MSCI
nraghuraman@wustl.edu
3142732939
Time Frame
Start Date: 2023-05-22
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 2124
Treatments
Other: Oxygen
Active_comparator: Room air
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: Brown University, Dell Children's Medical Center of Central Texas, University of Michigan, University of Texas at Austin, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Women and Infants Hospital of Rhode Island

This content was sourced from clinicaltrials.gov