Maternal Oxygen Supplementation for Intrauterine Resuscitation
- Conditions
- Labor and Delivery ComplicationFetal DistressFetal Hypoxia
- Interventions
- Other: Maternal oxygen supplementationOther: Room air
- Registration Number
- NCT05681624
- Lead Sponsor
- Washington University School of Medicine
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 2124
- Singleton gestation
- Gestational age>=37 weeks
- Spontaneous labor or induction of labor
- English or spanish speaking
- Planned continuous fetal monitoring
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Oxygen Maternal oxygen supplementation - Room air Room air -
- Primary Outcome Measures
Name Time Method Percentage of neonates meeting criteria for composite neonatal morbidity 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 Outcome Measures
Name Time Method Percentage of neonates with seizure 28 days of life Percentage of neonates with respiratory distress Within 72 hours of delivery Percentage of patients with composite maternal morbidity Within 2 weeks of delivery any diagnosis of the following: postpartum hemorrhage \[estimated blood loss \>1000 mL\]; severe perineal laceration, endometritis
Percentage of patients with operative delivery for the indication of nonreassuring fetal status At delivery Percentage of neonates with acidemia (pH<7.1) At time of delivery On delivery cord gas
Percentage of neonates with meconium aspiration with pulmonary hypertension Within 72 hours of delivery Percentage of neonates with Neonatal Intensive care unit admission Within 72 hours of delivery Perentage of patients with operative delivery (cesarean or operative vaginal delivery) At delivery Percentage of neonates with neonatal death 28 days of life umbilical artery base excess At delivery Percentage of neonates with hypoxic ischemic encephalopathy Within 72 hours of delivery Percentage of neonates with hypothermia treatment Within 72 hours of delivery umbilical artery partial pressure carbon dioxide At delivery Apgars at 5 and 10 minutes At 5 and 10 minutes of neonatal life Percentage of neonates with hypoglycemia Within 24 hours of delivery umbilical artery partial pressure oxygen At delivery Apgar<5 at 5 and 10 mins At 5 and 10 minutes of neonatal life
Trial Locations
- Locations (1)
Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States