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Using CPAP to treat sleep apnea in pregnant women

A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy

Not applicable Interventional The George Washington University Biostatistics Center · NCT03487185

This study is testing if using a CPAP machine can help pregnant women with sleep apnea lower their chances of developing high blood pressure and other pregnancy complications.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1500 (estimated)
Ages18 Years and up
SexFemale
SponsorThe George Washington University Biostatistics Center Academic / other
Locations14 sites (Birmingham, Alabama and 13 other locations)
Trial IDNCT03487185 on ClinicalTrials.gov

What this trial studies

This clinical trial involves 1,500 pregnant women diagnosed with mild to moderate obstructive sleep apnea (OSA) to evaluate the effectiveness of continuous positive airway pressure (CPAP) therapy in reducing hypertensive disorders during pregnancy. Participants will be randomized to receive either CPAP treatment or sleep advice control. The study aims to fill the knowledge gap regarding the impact of OSA treatment on maternal and neonatal outcomes, particularly concerning hypertension and gestational diabetes. The trial will assess whether CPAP can improve pregnancy outcomes by reducing the incidence of these complications.

Who should consider this trial

Good fit: Ideal candidates are pregnant women with singleton gestation, between 14 to 21 weeks of gestation, and diagnosed with mild to moderate OSA.

Not a fit: Patients who have previously received treatment for sleep apnea or have chronic conditions that may interfere with CPAP therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of hypertensive disorders in pregnant women with sleep apnea.

How similar studies have performed: While there is limited data on the effects of CPAP in pregnant populations, similar approaches in non-pregnant individuals have shown success in managing OSA and related complications.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Obstructive Sleep Apnea of AdultPreeclampsiaObstetrical ComplicationsCPAPApneapregnancy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.