Prevalence Study of Sleep Apnea in Women With Preeclampsia

January 7, 2010 updated by: University of Saskatchewan

Sleep Disordered Breathing and Preeclampsia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital Sleep Disorders Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the prevalence of sleep apnea in preeclampsia and pregnancy.
Time Frame: Time of delivery for each woman
Time of delivery for each woman

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time of delivery for each woman

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Collaborators

Saskatchewan Health Research Foundation

Investigators

  • Principal Investigator: John K Reid, MD, BSc, University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

November 28, 2005

First Submitted That Met QC Criteria

November 28, 2005

First Posted (Estimate)

November 29, 2005

Study Record Updates

Last Update Posted (Estimate)

January 8, 2010

Last Update Submitted That Met QC Criteria

January 7, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO-REB 05-110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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