Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Location status: Recruiting
Location contact
Nandini Raghuraman, MD MS
CONTACT
NCT Number: NCT05681624
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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Interventional
Not applicable
St Louis, Missouri, 63110, United States
Location status: Recruiting
Nandini Raghuraman, MD MS
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Maternal oxygen supplementation 10 liters/minute via nonrebreather mask
Room air, no mask
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
Time frame: At delivery
Time frame: At delivery
Time frame: 28 days of life
Time frame: At time of delivery
On delivery cord gas
Time frame: Within 72 hours of delivery
Time frame: Within 24 hours of delivery
Time frame: Within 72 hours of delivery
Time frame: Within 72 hours of delivery
Time frame: 28 days of life
Time frame: Within 72 hours of delivery
Time frame: At delivery
Time frame: At delivery
Time frame: At delivery
Time frame: Within 2 weeks of delivery
any diagnosis of the following: postpartum hemorrhage [estimated blood loss >1000 mL]; severe perineal laceration, endometritis
Time frame: At 5 and 10 minutes of neonatal life
Time frame: At 5 and 10 minutes of neonatal life
Time frame: Within 72 hours of delivery
Contact information is provided by the study sponsor or research team.
Washington University School of Medicine
Other
Maternal Oxygen Supplementation for Intrauterine Resuscitation: a Multicenter Randomized Trial
Acronym: MOXY
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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