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Active, not recruitingNCT03487185SLEEPUpdated Aug 5, 2026

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

An interventional study of Continuous Positive Airway Pressure and Sleep Advice Control in Obstructive Sleep Apnea of Adult, Preeclampsia and Obstetrical Complications, sponsored by The George Washington University Biostatistics Center. Active, not recruiting at 14 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by The George Washington University Biostatistics Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,500
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

Emerging data support a link between sleep disordered breathing (SDB) and adverse pregnancy outcomes. In particular, women with obstructive sleep apnea (OSA) appear to be at increased risk of both hypertensive disorders of pregnancy and gestational diabetes. In the non-pregnant population, OSA is typically treated with continuous positive airway pressure (CPAP) during sleep and has been shown to reduce blood pressure in hypertensive patients. Unfortunately, data on whether maternal and neonatal outcomes could be improved with treatment of OSA during pregnancy are extremely limited. This study aims to address this knowledge gap.

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.

02

Conditions studied

  • Obstructive Sleep Apnea of Adult
  • Preeclampsia
  • Obstetrical Complications

Keywords

  • CPAP
  • Apnea
  • pregnancy
03

In context

Pre-Eclampsia

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

The George Washington University Biostatistics Center is the lead sponsor of 25 studies on the registry; 3 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
1,500 participants (estimated)

Study arms

  • Experimental
    Continuous Positive Airway Pressure

    Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling

    Device: Continuous Positive Airway Pressure

  • Other
    Sleep Advice Control

    Initial sleep advice counseling alone

    Other: Sleep Advice Control

Interventions

  • DeviceContinuous Positive Airway Pressure

    Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling

    Also known as: CPAP

  • OtherSleep Advice Control

    Initial sleep advice counseling alone

06

What researchers measure

Primary outcomes

  1. Diagnosis of Hypertensive Disorders of Pregnancy

    Subjects are considered to have the primary outcome if they meet the criteria for eclampsia, HELLP, atypical HELLP, preeclampsia, superimposed preeclampsia or antepartum gestational hypertension.

    Time frame: Up to 14 days postpartum

Secondary outcomes

  1. Gestational diabetes

    Gestational diabetes by oral GTT criteria performed after randomization

    Time frame: As soon as possible after randomization between 14 weeks, 0 days and 21 weeks, 6 days gestation

  2. Preterm birth

    Preterm birth less than 34 weeks and less than 37 weeks

    Time frame: Preterm delivery up to and less than 37 weeks gestation

  3. Cesarean Delivery

    Delivery by cesarean section

    Time frame: At the time of delivery

  4. Maternal morbidity composite

    Maternal morbidity composite defined as the occurrence of one of the following: * Maternal death * Transfusion of ≥ 4 units of PRBC within 6 weeks postpartum * ICU admission within 6 weeks postpartum

    Time frame: Within 6 weeks postpartum

  5. Maternal adverse cardiovascular outcome composite

    Maternal adverse cardiovascular outcome composite defined as the occurrence of one or more of the following: * Venous thromboembolism * New onset heart failure with ejection fraction (EF) \< 40% * Cerebrovascular accident * Myocardial infarction * New onset atrial fibrillation

    Time frame: By 6 weeks postpartum

  6. Fetal or Neonatal Death

    Antepartum, intrapartum, or neonatal death

    Time frame: through 72 hours postpartum

  7. Neonatal respiratory support

    Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation

    Time frame: within 72 hours of delivery

  8. Birth weight

    1. Small for gestational age defined as \< 5th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data 2. Large for gestational age defined as greater than the 90th percentile for gestational age. 3. Macrosomia defined as birthweight \> 4000 grams

    Time frame: Immediately post birth

  9. Neonatal encephalopathy

    Neonatal encephalopathy as defined by the NICHD Neonatal Research Network criteria

    Time frame: within 72 hours of delivery

  10. Neonatal Seizures

    Neonatal seizure activity confirmed by central review

    Time frame: 72 hours post birth

  11. Shoulder dystocia

    Shoulder dystocia during delivery

    Time frame: During delivery

  12. Birth trauma

    Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy

    Time frame: During delivery

  13. Intracranial hemorrhage

    Intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma

    Time frame: Within 72 hours post delivery

  14. Hyperbilirubinemia

    Hyperbilirubinemia requiring phototherapy or exchange transfusion

    Time frame: Within 72 hours post delivery

  15. Hypoglycemia

    glucose \< 35 mg/dl requiring IV therapy

    Time frame: Within 72 hours post delivery

  16. NICU Stay

    Neonatal Intensive Care Unit stay

    Time frame: Greater than or equal to 72 hours post birth

07

Study locations

14 sites
08

References and documents

Publications

  • Facco F. Sleep Duration, Sleep Timing, and Sleep Disordered Breathing-Associations With Obesity and Gestational Diabetes in Pregnancy. Clin Obstet Gynecol. 2021 Mar 1;64(1):196-203. doi: 10.1097/GRF.0000000000000587. PubMed 33481418 ↗

Individual participant data

Plan to share: Yes — The dataset will be shared per NIH policy after the completion and publication of the main analyses.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2018 (actual). Primary completion is estimated for Oct 2026, 98 months after the start.

Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 98 months is above that.

Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2018
First posted
Apr 3, 2018
StartActual
Aug 3, 2018
Primary completionEst.
Oct 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Aug 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03487185
Lead sponsor
The George Washington University Biostatistics Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Apr 3, 2018
Start date
Aug 3, 2018
Primary completion
Oct 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 5, 2026

Study contacts

Rebecca Clifton, PhD
principal investigator · The George Washington University Biostatistics Center
Monica Longo, MD
study director · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Francesca Facco, MD
study chair · Magee Women's Hospital of UPMC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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