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Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
NCT03487185 · The George Washington University Biostatistics Center
In plain English
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Official title
A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
About this study
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
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.
Study design
Enrollment target: 1500 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2018-08-03
Estimated completion: 2026-12-31
Last updated: 2026-04-06
Interventions
Device: Continuous Positive Airway PressureOther: Sleep Advice Control
Primary outcomes
- • Diagnosis of Hypertensive Disorders of Pregnancy (Up to 14 days postpartum)
Sponsor
The George Washington University Biostatistics Center · other
With: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI)
Contacts & investigators
ContactRebecca Clifton, PhD · contact · rclifton@bsc.gwu.edu · 301-881-9260
InvestigatorRebecca Clifton, PhD · principal_investigator, The George Washington University Biostatistics Center
InvestigatorMonica Longo, MD · study_director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
InvestigatorFrancesca Facco, MD · study_chair, Magee Women's Hospital of UPMC
All locations (14)
University of Alabama - BirminghamRecruiting
Birmingham, Alabama, United States
Regents of the University of California San FranciscoRecruiting
San Francisco, California, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Columbia UniversityRecruiting
New York, New York, United States
University of North Carolina - Chapel HillRecruiting
Chapel Hill, North Carolina, United States
Case Western Reserve-Metro HealthRecruiting
Cleveland, Ohio, United States
Ohio State University HospitalRecruiting
Columbus, Ohio, United States
Hospital of the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Magee Women's Hospital of UPMCRecruiting
Pittsburgh, Pennsylvania, United States
Brown UniveristyActive Not Recruiting
Providence, Rhode Island, United States
University of Texas Medical BranchActive Not Recruiting
Galveston, Texas, United States
Baylor College of MedicineRecruiting
Houston, Texas, United States
University of Texas - HoustonRecruiting
Houston, Texas, United States
University of Utah Medical CenterRecruiting
Salt Lake City, Utah, United States