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

Running, not enrolling · Not applicable

Conditions studied: Obstructive Sleep Apnea of Adult, Preeclampsia, Obstetrical Complications

In brief

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.

Key facts

Study ID

NCT03487185

Run by

The George Washington University Biostatistics Center

People needed

1500

Starts

2018-08-03

Expected to finish

2026-12-31

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.
• Gestational age at randomization between 14 weeks 0 days and 21 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
• Diagnosis with mild to moderate OSA as defined by an AHI score ≥ 5 and <30.

You may not qualify if…

• Previously prescribed, current or planned therapy for sleep apnea.
• Age < 18 years, because the rate of sleep apnea in this population is extremely low.
• Inability to sleep in a stable place with access to the CPAP machine at least 5 nights per week.
• 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.
• Current use of prescribed sleeping pills for insomnia.
• 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.
• Chronic renal disease with serum creatinine >1.3 mg/dL because the primary outcome would be pre-determined.
• Antiphospholipid antibody syndrome, because it would compromise the primary outcome diagnosis.
• History of medical complications such as:
• Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)
• Thrombocytopenia with platelet count <100,000 because of the difficulty in assessing the primary outcome.
• Active vaginal bleeding (more than spotting) at the time of randomization.
• Known chromosomal, genetic, major malformations or fetal demise, or planned termination of pregnancy because inclusion would compromise evaluation of secondary neonatal outcomes.
• Known major uterine malformations associated with adverse pregnancy outcomes.
• Current use of opiates (heroin, methadone, or other daily opioid use) due to inaccuracy of the home sleep test and inefficiency of CPAP.
• Active drug use, alcohol use, or unstable psychiatric condition.
• Participation in another interventional study that influences preeclampsia, hypertensive disorders of pregnancy, or GDM.
• 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.
• Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.

Where it is running

• University of Alabama - Birmingham — Birmingham, Alabama, United States
• Regents of the University of California San Francisco — San Francisco, California, United States
• Northwestern University — Chicago, Illinois, United States
• Columbia University — New York, New York, United States
• University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
• Case Western Reserve-Metro Health — Cleveland, Ohio, United States
• Ohio State University Hospital — Columbus, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Magee Women's Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• Brown Univeristy — Providence, Rhode Island, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Texas - Houston — Houston, Texas, United States
• University of Utah Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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