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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05681624
Other study ID # 202209042
Secondary ID R01HD108614
Status Recruiting
Phase N/A
First received
Last updated
Start date May 22, 2023
Est. completion date August 1, 2027

Study information

Verified date May 2024
Source Washington University School of Medicine
Contact Nandini Raghuraman, MD MSCI
Phone 3142732939
Email nraghuraman@wustl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2124
Est. completion date August 1, 2027
Est. primary completion date April 1, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Singleton gestation - Gestational age>=37 weeks - Spontaneous labor or induction of labor - English or spanish speaking - Planned continuous fetal monitoring Exclusion Criteria: - Preterm gestation - Major fetal anomaly - Multiple gestation - Category III fetal monitoring at time of admission - Maternal hypoxia <95% - Planned or scheduled cesarean delivery Excluded from randomization if receiving nitrous oxide for analgesia at time of randomization.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Maternal oxygen supplementation
Maternal oxygen supplementation 10 liters/minute via nonrebreather mask
Room air
Room air, no mask

Locations

Country Name City State
United States Barnes Jewish Hospital Saint Louis Missouri

Sponsors (7)

Lead Sponsor Collaborator
Washington University School of Medicine Brown University, Dell Children's Medical Center of Central Texas, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Michigan, University of Texas at Austin, Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Up to 28 days of life
Secondary Perentage of patients with operative delivery (cesarean or operative vaginal delivery) At delivery
Secondary Percentage of patients with operative delivery for the indication of nonreassuring fetal status At delivery
Secondary Percentage of neonates with neonatal death 28 days of life
Secondary Percentage of neonates with acidemia (pH<7.1) On delivery cord gas At time of delivery
Secondary Percentage of neonates with meconium aspiration with pulmonary hypertension Within 72 hours of delivery
Secondary Percentage of neonates with hypoglycemia Within 24 hours of delivery
Secondary Percentage of neonates with hypoxic ischemic encephalopathy Within 72 hours of delivery
Secondary Percentage of neonates with hypothermia treatment Within 72 hours of delivery
Secondary Percentage of neonates with seizure 28 days of life
Secondary Percentage of neonates with respiratory distress Within 72 hours of delivery
Secondary umbilical artery base excess At delivery
Secondary umbilical artery partial pressure oxygen At delivery
Secondary umbilical artery partial pressure carbon dioxide At delivery
Secondary Percentage of patients with composite maternal morbidity any diagnosis of the following: postpartum hemorrhage [estimated blood loss >1000 mL]; severe perineal laceration, endometritis Within 2 weeks of delivery
Secondary Apgars at 5 and 10 minutes At 5 and 10 minutes of neonatal life
Secondary Apgar<5 at 5 and 10 mins At 5 and 10 minutes of neonatal life
Secondary Percentage of neonates with Neonatal Intensive care unit admission Within 72 hours of delivery
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