RecruitingNot ApplicableNCT03487185
Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
Sponsor
The George Washington University Biostatistics Center
Enrollment
1,500 participants
Start Date
Aug 3, 2018
Study Type
INTERVENTIONAL
Conditions
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
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria3
- 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 Criteria19
- 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.
Interventions
DEVICEContinuous Positive Airway Pressure
Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling
OTHERSleep Advice Control
Initial sleep advice counseling alone
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03487185
Related Trials
Placental Imaging Techniques
NCT068613091 location
Vascular Effects of High-Salt After Preeclampsia
NCT067494181 location
Effects of High Altitude on AMPK Activation
NCT023915191 location
Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy
NCT059998511 location
Impact GLP-1 Agonists Following Bariatric
NCT061324771 location