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

Korábbi kezelés

• Previously prescribed, current or planned therapy for sleep apnea.
• 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.
• Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.

Más betegség

• 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.
• Antiphospholipid antibody syndrome, because it would compromise the primary outcome diagnosis.
• Active vaginal bleeding (more than spotting) at the time of randomization.
• Active drug use, alcohol use, or unstable psychiatric condition.
• Participation in another interventional study that influences preeclampsia, hypertensive disorders of pregnancy, or GDM.

Laborértékek

• Chronic renal disease with serum creatinine \>1.3 mg/dL because the primary outcome would be pre-determined.
• 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.

Életkor

• Age \< 18 years, because the rate of sleep apnea in this population is extremely low.

Egyéb

• Inability to sleep in a stable place with access to the CPAP machine at least 5 nights per week.
• Current use of prescribed sleeping pills for insomnia.
• 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.
• 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.

• 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.