RecruitingNot Applicable

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

United States1,500 participantsStarted 2018-08-03

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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.

What they're measuring

Diagnosis of Hypertensive Disorders of Pregnancy

Timeframe: Up to 14 days postpartum

Trial details

NCT IDNCT03487185

SponsorThe George Washington University Biostatistics Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Rebecca Clifton, PhD

301-881-9260 rclifton@bsc.gwu.edu

View on ClinicalTrials.gov More Obstructive Sleep Apnea of Adult trials