Status:
RECRUITING
Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
Lead Sponsor:
The George Washington University Biostatistics Center
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obstructive Sleep Apnea of Adult
Preeclampsia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 ...
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 hyp...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
August 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT03487185
Start Date
August 3 2018
End Date
December 31 2026
Last Update
February 17 2025
Active Locations (14)
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1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35233
2
Regents of the University of California San Francisco
San Francisco, California, United States, 94143
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Columbia University
New York, New York, United States, 10032