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

Last updated: February 14, 2025
Sponsor: The George Washington University Biostatistics Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Labor/delivery

Pregnancy Complications

Treatment

Continuous Positive Airway Pressure

Sleep Advice Control

Clinical Study ID

NCT03487185
HD36801-SLEEP
UG1HD112063
UG1HD112096
UG1HD112092
UG1HD087192
UG1HD040560
UG1HD087230
UG1HD040512
UG1HD040500
UG1HD027869
UG1HD040544
UG1HD027915
U24HD036801
UG1HD040485
UG1HD034208
UG1HD040545
UG1HD053097
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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:

  10. Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)

  11. Thrombocytopenia with platelet count <100,000 because of the difficulty in assessing the primary outcome.

  12. Active vaginal bleeding (more than spotting) at the time of randomization.

  13. Known chromosomal, genetic, major malformations or fetal demise, or planned termination of pregnancy because inclusion would compromise evaluation of secondary neonatal outcomes.

  14. Known major uterine malformations associated with adverse pregnancy outcomes.

  15. Current use of opiates (heroin, methadone, or other daily opioid use) due to inaccuracy of the home sleep test and inefficiency of CPAP.

  16. Active drug use, alcohol use, or unstable psychiatric condition.

  17. Participation in another interventional study that influences preeclampsia, hypertensive disorders of pregnancy, or GDM.

  18. 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.

  19. Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.

Study Design

Total Participants: 1500
Treatment Group(s): 2
Primary Treatment: Continuous Positive Airway Pressure
Phase:
Study Start date:
August 03, 2018
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • University of Alabama - Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Regents of the University of California San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Columbia University

    New York, New York 10032
    United States

    Active - Recruiting

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Case Western Reserve-Metro Health

    Cleveland, Ohio 44109
    United States

    Active - Recruiting

  • Ohio State University Hospital

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Magee Women's Hospital of UPMC

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Brown Univeristy

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas - Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Utah Medical Center

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

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