NCT03487185 Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
| NCT ID | NCT03487185 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The George Washington University Biostatistics Center |
| Condition | Obstructive Sleep Apnea of Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2018-08-03 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,500 participants in total. It began in 2018-08-03 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 of hypertensive disorders of pregnancy.
Eligibility Criteria
Inclusion Criteria 1. Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age. 2. Gestational age at randomization between 14 weeks 0 days and 21 weeks 6 days based on clinical information and evaluation of the earliest ultrasound. 3. Diagnosis with mild to moderate OSA as defined by an AHI score ≥ 5 and \<30. Exclusion Criteria 1. Previously prescribed, current or planned therapy for sleep apnea. 2. Age \< 18 years, because the rate of sleep apnea in this population is extremely low. 3. Inability to sleep in a stable place with access to the CPAP machine at least 5 nights per week. 4. 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. 5. Current use of prescribed sleeping pills for insomnia. 6. 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. 7. Chronic renal disease with serum creatinine \>1.3 mg/dL because the primary outcome would be pre-determined. 8. Antiphospholipid antibody syndrome, because it would compromise the primary outcome diagnosis. 9. History of medical complications such as: 1. Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes) 2. Thrombocytopenia with platelet count \<100,000 because of the difficulty in assessing the primary outcome. 10. Active vaginal bleeding (more than spotting) at the time of randomization. 11. Known chromosomal, genetic, major malformations or fetal demise, or planned termination of pregnancy because inclusion would compromise evaluation of secondary neonatal outcomes. 12. Known major uterine malformations associated with adverse pregnancy outcomes. 13. Current use of opiates (heroin, methadone, or other daily opioid use) due to inaccuracy of the home sleep test and inefficiency of CPAP. 14. Active drug use, alcohol use, or unstable psychiatric condition. 15. Participation in another interventional study that influences preeclampsia, hypertensive disorders of pregnancy, or GDM. 16. 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. 17. Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.
Contact & Investigator
Rebecca Clifton, PhD
PRINCIPAL INVESTIGATOR
The George Washington University Biostatistics Center
Frequently Asked Questions
Who can join the NCT03487185 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Obstructive Sleep Apnea of Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03487185 currently recruiting?
Yes, NCT03487185 is actively recruiting participants. Contact the research team at rclifton@bsc.gwu.edu for enrollment information.
Where is the NCT03487185 trial being conducted?
This trial is being conducted at Birmingham, United States, San Francisco, United States, Chicago, United States, New York, United States and 10 additional locations.
Who is sponsoring the NCT03487185 clinical trial?
NCT03487185 is sponsored by The George Washington University Biostatistics Center. The principal investigator is Rebecca Clifton, PhD at The George Washington University Biostatistics Center. The trial plans to enroll 1,500 participants.