Maternal Oxygen Supplementation for Intrauterine Resuscitation

Fetal Distress Clinical Trial

— MOXY  

Official title:

Maternal Oxygen Supplementation for Intrauterine Resuscitation: a Multicenter Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

• Verified date: March 2024
• Source: Washington University School of Medicine
• Contact: Nandini Raghuraman, MD MSCI
• Phone: 3142732939
• Email: nraghuraman[@]wustl.edu
• Is FDA regulated: No
• 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: February 28, 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.

Related Conditions & MeSH terms

• Fetal Distress
• Fetal Hypoxia
• Hypoxia

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