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Recruiting NCT05681624

Maternal Oxygen Supplementation for Intrauterine Resuscitation

No phase Interventional Fetal Distress Fetal Hypoxia Labor and Delivery Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Maternal oxygen supplementation, Room air.
Who it may be relevant to
Registry conditions: Fetal Distress, Fetal Hypoxia, Labor and Delivery Complication. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Maternal Oxygen Supplementation for Intrauterine Resuscitation: a Multicenter Randomized Trial

Overview

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.

Interventions

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

Primary outcome measures

  • Percentage of neonates meeting criteria for composite neonatal morbidity [Time frame: Up to 28 days of life]
Secondary outcome measures (12)
  • Perentage of patients with operative delivery (cesarean or operative vaginal delivery) [Time frame: At delivery]
  • Percentage of patients with operative delivery for the indication of nonreassuring fetal status [Time frame: At delivery]
  • Percentage of neonates with neonatal death [Time frame: 28 days of life]
  • Percentage of neonates with acidemia (pH<7.1) [Time frame: At time of delivery]
  • Percentage of neonates with meconium aspiration with pulmonary hypertension [Time frame: Within 72 hours of delivery]
  • Percentage of neonates with hypoglycemia [Time frame: Within 24 hours of delivery]
  • Percentage of neonates with hypoxic ischemic encephalopathy [Time frame: Within 72 hours of delivery]
  • Percentage of neonates with hypothermia treatment [Time frame: Within 72 hours of delivery]
  • Percentage of neonates with seizure [Time frame: 28 days of life]
  • Percentage of neonates with respiratory distress [Time frame: Within 72 hours of delivery]
  • umbilical artery base excess [Time frame: At delivery]
  • umbilical artery partial pressure oxygen [Time frame: At delivery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Barnes Jewish Hospital — St Louis

Identifiers

NCT: NCT05681624 · 202209042 · R01HD108614

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗