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Prevalence Study of Sleep Apnea in Women With Preeclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259688
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : January 8, 2010
Saskatchewan Health Research Foundation
Information provided by:
University of Saskatchewan

Brief Summary:
Hypothesis: The prevalence of sleep apnea is greater in pregnant women with preeclampsia than in pregnant women without preeclampsia.The presence of sleep apnea will be associated with poor blood pressure control, worsening blood pressure during sleep and evidence of fetal distress. The usual treatment for sleep apnea is to have the patient breathe pressurized air through a mask. This is called continuous positive airway pressure (CPAP). In preeclamptic women with sleep apnea, use of CPAP will result in improved blood pressure control and reduced fetal distress.

Condition or disease Intervention/treatment Phase
Preeclampsia Device: CPAP therapy for subjects diagnosed with sleep apnea Phase 2

Detailed Description:
Sleep apnea is common in the adult population. In middle aged men, the presence of sleep apnea has been correlated with hypertension, cardiovascular disease and mood disorders. Sleep apnea is not as well studied in women and even less is known about sleep apnea in pregnant women. However, preliminary evidence suggests that the incidence is quite high, particularly in women with severe preeclampsia. We propose to perform sleep studies on 30 women with preeclampsia and 30 healthy pregnant controls. In addition to the usual sleep study monitoring, we will also measure beat-to-beat blood pressure through non-invasive monitoring and we will do continuous electronic fetal monitoring. Women found to have sleep apnea will have a repeat study in which CPAP therapy is applied, and be provided CPAP therapy for nightly use at home.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sleep Disordered Breathing and Preeclampsia
Study Start Date : February 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
No Intervention: 1
Women with gestational hypertension
No Intervention: 2
Women with uncomplicated pregnancies
Device: CPAP therapy for subjects diagnosed with sleep apnea
CPAP therapy is being offered to women who are diagnosed on Polysomnogram with sleep apnea. However, this is not an intervention study and treatment is not part of the study protocol.

No Intervention: 3
Re-test of women one to two years post-partum.

Primary Outcome Measures :
  1. Determine the prevalence of sleep apnea in preeclampsia and pregnancy. [ Time Frame: Time of delivery for each woman ]

Secondary Outcome Measures :
  1. For those subjects diagnoses with sleep apnea: Improvement in blood pressure and electronic fetal monitoring during with use of CPAP. [ Time Frame: Time of delivery for each woman ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Pregnant women >18 years of age

Exclusion Criteria:

  • significant medical conditions that would be expected to affect maternal- fetal outcomes
  • need for admission to hospital, so that it transfer to the sleep would compromise maternal-fetal safety

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259688

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Canada, Saskatchewan
Royal University Hospital Sleep Disorders Centre
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Saskatchewan Health Research Foundation
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Principal Investigator: John K Reid, MD, BSc University of Saskatchewan
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Responsible Party: John Reid - Assistant Professor, University of Saskatchewan Identifier: NCT00259688    
Other Study ID Numbers: BIO-REB 05-110
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: January 8, 2010
Last Verified: January 2010
Keywords provided by University of Saskatchewan:
Sleep Apnea
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Pregnancy Complications