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NCT Number: NCT05681624

Maternal Oxygen Supplementation for Intrauterine Resuscitation

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Nandini Raghuraman, MD MS

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maternal oxygen supplementation

Other

Maternal oxygen supplementation 10 liters/minute via nonrebreather mask

Room air

Other

Room air, no mask

Primary outcomes

  1. Percentage of neonates meeting criteria for composite neonatal morbidity

    Time frame: Up to 28 days of life

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

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)

    Time frame: At time of delivery

    On delivery cord gas

  5. Percentage of neonates with meconium aspiration with pulmonary hypertension

    Time frame: Within 72 hours of delivery

  6. Percentage of neonates with hypoglycemia

    Time frame: Within 24 hours of delivery

  7. Percentage of neonates with hypoxic ischemic encephalopathy

    Time frame: Within 72 hours of delivery

  8. Percentage of neonates with hypothermia treatment

    Time frame: Within 72 hours of delivery

  9. Percentage of neonates with seizure

    Time frame: 28 days of life

  10. Percentage of neonates with respiratory distress

    Time frame: Within 72 hours of delivery

  11. umbilical artery base excess

    Time frame: At delivery

  12. umbilical artery partial pressure oxygen

    Time frame: At delivery

  13. umbilical artery partial pressure carbon dioxide

    Time frame: At delivery

  14. Percentage of patients with composite maternal morbidity

    Time frame: Within 2 weeks of delivery

    any diagnosis of the following: postpartum hemorrhage [estimated blood loss >1000 mL]; severe perineal laceration, endometritis

  15. Apgars at 5 and 10 minutes

    Time frame: At 5 and 10 minutes of neonatal life

  16. Apgar<5 at 5 and 10 mins

    Time frame: At 5 and 10 minutes of neonatal life

  17. Percentage of neonates with Neonatal Intensive care unit admission

    Time frame: Within 72 hours of delivery

Study contacts

Contact information is provided by the study sponsor or research team.

Nandini Raghuraman, MD MSCI

CONTACT

[email protected]

3142732939

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • 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

Registry information

Official study title

Maternal Oxygen Supplementation for Intrauterine Resuscitation: a Multicenter Randomized Trial

Acronym: MOXY

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 12, 2023
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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