A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
The George Washington University Biostatistics Center
Summary
A randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.
Description
Emerging data support a link between sleep disordered breathing (SDB) and adverse pregnancy outcomes. In particular, women with obstructive sleep apnea (OSA) appear to be at increased risk of both hypertensive disorders of pregnancy and gestational diabetes. In the non-pregnant population, OSA is typically treated with continuous positive airway pressure (CPAP) during sleep and has been shown to reduce blood pressure in hypertensive patients. Unfortunately, data on whether maternal and neonatal outcomes could be improved with treatment of OSA during pregnancy are extremely limited. This study…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria 1. Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age. 2. Gestational age at randomization between 14 weeks 0 days and 21 weeks 6 days based on clinical information and evaluation of the earliest ultrasound. 3. Diagnosis with mild to moderate OSA as defined by an AHI score ≥ 5 and \<30. Exclusion Criteria 1. Previously prescribed, current or planned therapy for sleep apnea. 2. Age \< 18 years, because the rate of sleep apnea in this populat…
Interventions
- DeviceContinuous Positive Airway Pressure
Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling
- OtherSleep Advice Control
Initial sleep advice counseling alone
Locations (14)
- University of Alabama - BirminghamBirmingham, Alabama
- Regents of the University of California San FranciscoSan Francisco, California
- Northwestern UniversityChicago, Illinois
- Columbia UniversityNew York, New York
- University of North Carolina - Chapel HillChapel Hill, North Carolina
- Case Western Reserve-Metro HealthCleveland, Ohio