Effect of Oxygen vs Room Air on Intrauterine Fetal Resuscitation: A Randomized Noninferiority Clinical Trial

Abstract

Importance: Two-thirds of women in labor receive supplemental oxygen to reverse perceived fetal hypoxemia and prevent acidemia. Oxygen is routinely administered for category II fetal heart tracings, a class of fetal tracing used to designate intermediate risk for acidemia. This liberal use of oxygen may not be beneficial, particularly because neonatal hyperoxygenation is harmful.

Objective: To test the hypothesis that room air is noninferior to oxygen in improving fetal metabolic status among patients with category II fetal heart tracings.

Design, setting, and participants: This was a randomized, unblinded noninferiority clinical trial conducted between June 2016 and July 2017 in the labor and delivery ward of a single tertiary care center. Women with singleton pregnancies at 37 weeks' gestational age or more who were admitted for delivery were eligible. Of those who met inclusion criteria, the patients who developed category II tracings in labor that necessitated intrauterine resuscitation were randomized in a 1:1 ratio to room air or oxygen. Analyses were intention-to-treat.

Interventions: The oxygen group received 10 L of oxygen per minute by nonrebreather facemask until delivery. The room air group was exposed to room air only without a facemask.

Main outcomes and measures: The primary outcome was umbilical artery lactate, a marker of metabolic acidosis and neonatal morbidity. Noninferiority was defined as a mean difference between groups of less than 9.0 mg/dL (1.0 mmol/L). Secondary outcomes were other umbilical artery gases, cesarean delivery for nonreassuring fetal status, and operative vaginal delivery.

Results: Of the 705 patients who met inclusion criteria, 277 (39.3%) were enrolled on admission. During labor, 114 patients (41.2% of the enrolled patients) developed category II tracings and were randomized to room air (57 patients; 50.0% of the randomized patients) or oxygen (57 patients; 50.0% of the randomized patients). A total of 99 patients (86.8% of the randomized patients) with paired cord gases were included in the modified intention-to-treat analysis. The 99 patients included 76 African American women (77%); mean (SD) age was 27.3 (6.3) years in the oxygen group and 27.8 (5.3) years in the room air group. There was no difference in umbilical artery lactate between the group on oxygen and the group on room air (mean, 30.6 mg/dL [95% CI, 27.0 to 34.2 mg/dL] vs 31.5 mg/dL [95% CI, 27.9 to 36.0 mg/dL]); P = .69). The mean difference in lactate was 0.9 mg/dL (95% CI, -4.5 to 6.3 mg/dL), which was within the noninferiority margin. There was no difference in other umbilical artery gas components or mode of delivery between groups.

Conclusions and relevance: Among patients with category II fetal heart tracings, intrauterine resuscitation with room air is noninferior to oxygen in improving umbilical artery lactate. The results of this trial challenge the efficacy of a ubiquitous obstetric practice and suggest that room air may be an acceptable alternative.

Trial registration: ClinicalTrials.gov Identifier: NCT02741284.

Figure 1.. Flowchart of Study Participants

Figure 2.. Mean Umbilical Artery Lactate in Patients Randomized to Oxygen and Room Air

The blue line indicates the noninferiority margin; black dots mark the mean and error bars the 95% CIs. SI conversion factors: to convert lactate to mmol/L, multiply by 0.111.