Status: Funded - Open
Oxygen for category II intrauterine fetal resuscitation: a randomized, noninferiority trial
Nandini Raghuraman, MD, MS
BACKGROUND: Provide one to two sentences explaining the problem.
Women with Category II electronic fetal monitoring (EFM) patterns commonly receive O2 to increase O2 transfer to the fetus and potentially reverse fetal hypoxemia. Liberal use of O2 in this setting is concerning because hyperoxygenation for neonatal resuscitation is associated with an increased risk of neonatal morbidity and production of dangerous free radicals.
GAP: Provide one to two sentences outline the gap your study addresses in the medical research.
This study will address the utility of intrapartum O2 administration for intrauterine resuscitation by comparing the effects of O2 vs room air (RA) on cord gas markers of neonatal morbidity, oxidative stress/free radical activity, and neonatal outcomes.
HYPOTHESIS: Provide one to two sentences stating the hypothesis of your study.
Our hypothesis is that RA is not inferior to maternal O2 administration for Category II EFM and will, in fact, be safer for intrauterine fetal resuscitation.
METHODS: Provide one to two sentences describing the study design and study participants.
This is a prospective, randomized, controlled, non-inferiority trial comparing maternal O2 administration to RA for Category II EFM necessitating intrauterine resuscitation in active labor. The study population will include women with term, singleton pregnancies admitted for delivery who develop Category II EFM in active labor and will exclude those with multiple gestations, fetal anomalies, Category I or III EFM, abnormal umbilical artery Dopplers, or maternal need for O2.
IMPACT: Provide one to two sentences describing how these findings may impact the health of children.
Every year in the US, approximately 600,000 to 700,000 neonates are exposed to O2 via intrapartum maternal hyperoxygenation. If the results of this trial support the hypothesis that RA is equally efficacious and safer than O2 for intrauterine resuscitation, we could minimize potential risks to the neonate by limiting liberal oxygen administration in labor.