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Search / Trial NCT03487185

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

Launched by THE GEORGE WASHINGTON UNIVERSITY BIOSTATISTICS CENTER · Mar 27, 2018

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Cpap Apnea Pregnancy

ClinConnect Summary

This clinical trial is studying whether using a device called Continuous Positive Airway Pressure (CPAP) can help pregnant women with a condition called obstructive sleep apnea (OSA) reduce their chances of experiencing high blood pressure problems during pregnancy, which can lead to complications. The trial is looking for 1,500 women who are between 14 and 21 weeks pregnant, are carrying one baby, and have been diagnosed with mild to moderate sleep apnea.

To be eligible, women should not have previously used any sleep apnea treatment, and they need to have a suitable sleeping environment to use the CPAP machine at least five nights a week. Participants will be randomly assigned to either receive the CPAP treatment or not, and they will be monitored throughout the study to see how the treatment affects their pregnancy and overall health. It's important to note that women with certain medical conditions or who are using specific medications may not be able to participate. If you or someone you know is interested in joining the study, it could provide valuable information about managing sleep apnea during pregnancy.

Gender

FEMALE

Eligibility criteria

  • 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.

About The George Washington University Biostatistics Center

The George Washington University Biostatistics Center is a leading research institution dedicated to advancing the field of biostatistics through innovative methodologies and rigorous scientific inquiry. As a prominent sponsor of clinical trials, the center specializes in the design, analysis, and interpretation of complex data in health-related research. With a commitment to enhancing public health outcomes, the Biostatistics Center collaborates with academic, governmental, and industry partners to foster evidence-based practices and promote the development of effective therapeutic interventions. Through its expertise, the center plays a vital role in ensuring the integrity and reliability of clinical research data, ultimately contributing to informed decision-making in healthcare.

Locations

Chicago, Illinois, United States

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Salt Lake City, Utah, United States

Houston, Texas, United States

Galveston, Texas, United States

Columbus, Ohio, United States

Birmingham, Alabama, United States

Pittsburgh, Pennsylvania, United States

Cleveland, Ohio, United States

Providence, Rhode Island, United States

San Francisco, California, United States

Patients applied

0 patients applied

Trial Officials

Rebecca Clifton, PhD

Principal Investigator

The George Washington University Biostatistics Center

Monica Longo, MD

Study Director

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Francesca Facco, MD

Study Chair

Magee Women's Hospital of UPMC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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