A randomized controlled trial of sleep study surveillance with targeted autoregulated positive airway pressure therapy for obstructive sleep apnea in pregnancy.

BACKGROUND: Obstructive sleep apnea is associated with adverse pregnancy outcomes. The impact therapy for obstructive sleep apnea has on these pregnancy outcomes remains under investigated.

OBJECTIVE: This study aimed to determine the effects of targeted autoregulated positive airway pressure in women at risk of obstructive sleep apnea on adverse pregnancy outcomes, cost, and natural history of obstructive sleep apnea.

STUDY DESIGN: Pregnant women at high risk of obstructive sleep apnea were randomized to either a sleep study screening group receiving autoregulated positive airway therapy or a group not screened for obstructive sleep apnea receiving standard obstetrical care (control). Women in the sleep study-screened group received a sleep study at 2 periods during pregnancy, early (6-16 weeks of gestation) and late (27-33 weeks of gestation), with initiation of autoregulated positive airway therapy if their Apnea Hypopnea Index indicated ≥5 events per hour. Women of both groups had a sleep study 3 months after delivery. The primary outcome was effect on adverse pregnancy outcomes, a composite of hypertension, preterm birth, low birthweight, stillbirth, and diabetes mellitus. The secondary outcomes included obstructive sleep apnea severity and hospital costs.

RESULTS: Among 193 women randomized (100 in the sleep study-screened group and 93 in the control group; 6 lost to follow-up), there was no significant difference in composite adverse pregnancy outcomes (46.4% screened vs 43.3% control; P=.77), hypertension (23.7% screened vs 32.0% control; P=.25), preterm birth (13.4% screened vs 10.0% control; P=.5), low birthweight (5.2% screened vs 6.7% control; P=.76), stillbirth (1% screened vs 0% control; P=1), gestational diabetes (19.6% screened vs 13.3% control; P=.33), or mean cost ($12,185 screened vs $12,607 control). The Apnea Hypopnea Index increased throughout pregnancy, peaking at 3 months after delivery (P<.001). There were 24 subjects (25.8%) who had a new diagnosis of obstructive sleep apnea, with 6 in whom autoregulated positive airway was prescribed. The autoregulated positive airway compliance rates were poor with usage rates ranging from 2% (1 of 64 days) to 43% (6 of 14 days).

CONCLUSION: Targeted autoregulated positive airway therapy for obstructive sleep apnea did not decrease composite adverse pregnancy outcomes or hospital costs in the sleep study-screened high-risk pregnancy group compared with the group that received no obstructive sleep apnea screening. However, a small sample size, low autoregulated positive airway prescription rates, and poor compliance resulted in difficulty in drawing a definitive conclusion. The prevalence and severity of obstructive sleep apnea worsened throughout pregnancy, with the highest rates detected in the postpartum period. Large, multicenter clinical trials that are adequately powered are needed.