Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obstetrical Complications
- Obstructive Sleep Apnea of Adult
- Preeclampsia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Women who are between 14 weeks 0 days and 21 weeks 5 days with a singleton gestation and obstructive sleep apnea (OSA) will be randomized to one of two arms at participating MFMU Network clinical center: Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling Initial sleep advice counseling alone Masking: Double (Investigator, Outcomes Assessor)Masking Description: This study is an unmasked randomized controlled multi-center clinical trial.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 ty...
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 aims to address this knowledge gap. A randomized controlled trial of 2,700 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.
Tracking Information
- NCT #
- NCT03487185
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Principal Investigator: Rebecca Clifton, PhD The George Washington University Biostatistics Center Study Director: Andrew Bremer, MD, PhD, MAS Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Study Chair: Francesca Facco, MD Magee Women's Hospital of UPMC
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