Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy (NCT03487185) | Clinical Trial Compass
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 range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnosis of Hypertensive Disorders of Pregnancy
Timeframe: Up to 14 days postpartum
Trial details
NCT IDNCT03487185
SponsorThe George Washington University Biostatistics Center
. 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.