Treatment of obstructive sleep apnea in high risk pregnancy : a multicenter randomized controlled trial

Abstract

Obstructive sleep apnea (OSA) during pregnancy leads to adverse maternal-fetal outcomes particularly preeclampsia. Whether continuous positive airway pressure (CPAP) treatment can reduce blood pressure and the incidence of preeclampsia is uncertain. A multi-center open-label randomized controlled trial was conducted to receive CPAP treatment or usual care (control) on 1:1 ratio. Eligibility criteria included participants with singleton pregnancy during first trimester aged above 18 years with any of the followings; 1) chronic hypertension, 2) hypertension before 20 weeks of gestation, 3) obesity, 4) history of preeclampsia or gestational hypertension, 5) history of gestational diabetes, or 6) diabetes. Participants must have OSA with respiratory disturbance index between 5-30 events/hour based on polysomnography. Primary outcomes were systolic and diastolic blood pressures during follow-ups. Secondary outcomes were pregnancy complications at delivery. Three-hundred and forty participants were recruited. Twenty-eight participants discontinued and 2 were excluded leaving 153 and 157 participants in the CPAP and control groups for intention-to-treat analyses. CPAP adherence rate was 32.7% with average nightly use of 2.5 hours. Primary outcomes showed reductions in systolic and diastolic blood pressures [mean (standard error); 114.1(1.0) vs 116.1(0.9) mmHg, p=0.148; 70.4(0.6) vs 72.5(0.6) mmHg, p=0.014]. Preeclampsia occurred in 20 participants in CPAP group (13.1%) and 35 participants in controls (22.3%); risk difference −0.09 [95% confidence interval (−0.18,−0.01), p=0.037] with number needed to treat of 11 (95% confidence interval: 1, 21). In conclusion, CPAP treatment in high risk pregnancy even with mild to moderate OSA demonstrated reductions in diastolic blood pressure and the incidence of preeclampsia.