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NCT03487185NARecruiting

Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy

The George Washington University Biostatistics Center

Start Date

8/3/2018

Completion Date

12/31/2026

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.

Detailed 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 aims to address this knowledge gap. 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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 population is extremely low. 3. Inability to sleep in a stable place with access to the CPAP machine at least 5 nights per week. 4. Asthma requiring systemic steroid therapy for more than 14 days within the past 6 months because this population is expected to be unresponsive to CPAP therapy. 5. Current use of prescribed sleeping pills for insomnia. 6. Chronic medical conditions requiring oxygen supplementation (e.g. pulmonary fibrosis, pulmonary hypertension, cystic fibrosis) because this population is expected to be unresponsive to CPAP therapy. 7. Chronic renal disease with serum creatinine \>1.3 mg/dL because the primary outcome would be pre-determined. 8. Antiphospholipid antibody syndrome, because it would compromise the primary outcome diagnosis. 9. History of medical complications such as: 1. Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes) 2. Thrombocytopenia with platelet count \<100,000 because of the difficulty in assessing the primary outcome. 10. Active vaginal bleeding (more than spotting) at the time of randomization. 11. Known chromosomal, genetic, major malformations or fetal demise, or planned termination of pregnancy because inclusion would compromise evaluation of secondary neonatal outcomes. 12. Known major uterine malformations associated with adverse pregnancy outcomes. 13. Current use of opiates (heroin, methadone, or other daily opioid use) due to inaccuracy of the home sleep test and inefficiency of CPAP. 14. Active drug use, alcohol use, or unstable psychiatric condition. 15. Participation in another interventional study that influences preeclampsia, hypertensive disorders of pregnancy, or GDM. 16. Prenatal care or delivery planned at a non-network center where access to the complete electronic medical record will not be available to research staff. 17. Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.

Interventions

DEVICE

Continuous Positive Airway Pressure

OTHER

Sleep Advice Control

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Conditions

Obstructive Sleep Apnea of AdultPreeclampsiaObstetrical Complications

Locations

University of Alabama - Birmingham

Birmingham, Alabama 35233

United States

Regents of the University of California San Francisco

San Francisco, California 94143

United States

Northwestern University

Chicago, Illinois 60611

United States

Columbia University

New York, New York 10032

United States

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina 27599

United States

Case Western Reserve-Metro Health

Cleveland, Ohio 44109

United States

Ohio State University Hospital

Columbus, Ohio 43210

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania 15213

United States

Brown Univeristy

Providence, Rhode Island 02905

United States

University of Texas Medical Branch

Galveston, Texas 77555

United States

Baylor College of Medicine

Houston, Texas 77030

United States

University of Texas - Houston

Houston, Texas 77030

United States

University of Utah Medical Center

Salt Lake City, Utah 84132

United States