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Can a sleep machine protect pregnant women from dangerous blood pressure?

NCT ID NCT03487185

Disease control Sponsor: The George Washington University Biostatistics Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This study looks at whether using a CPAP machine during pregnancy can reduce the chance of developing high blood pressure disorders like preeclampsia. About 1,500 pregnant women with mild to moderate sleep apnea will be randomly assigned to use CPAP or not. The goal is to see if treating sleep apnea helps prevent serious pregnancy complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Apnea obstetric disorder obstructive sleep apnea syndrome preeclampsia pregnancy disorder hypertension, pregnancy-induced prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obstetrical complications Obstructive sleep apnea of adult Preeclampsia

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Brown Univeristy

    Providence, Rhode Island, 02905, United States

  • Case Western Reserve-Metro Health

    Cleveland, Ohio, 44109, United States

  • Columbia University

    New York, New York, 10032, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Magee Women's Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ohio State University Hospital

    Columbus, Ohio, 43210, United States

  • Regents of the University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35233, United States

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Texas - Houston

    Houston, Texas, 77030, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555, United States

  • University of Utah Medical Center

    Salt Lake City, Utah, 84132, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.