Prevalence Study of Sleep Apnea in Women With Preeclampsia
Primary Purpose
Preeclampsia
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
CPAP therapy for subjects diagnosed with sleep apnea
Sponsored by
About this trial
This is an interventional diagnostic trial for Preeclampsia focused on measuring Preeclampsia, Sleep Apnea, CPAP
Eligibility Criteria
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
Sites / Locations
- Royal University Hospital Sleep Disorders Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
No Intervention
No Intervention
Arm Label
1
2
3
Arm Description
Women with gestational hypertension
Women with uncomplicated pregnancies
Re-test of women one to two years post-partum.
Outcomes
Primary Outcome Measures
Determine the prevalence of sleep apnea in preeclampsia and pregnancy.
Secondary Outcome Measures
For those subjects diagnoses with sleep apnea: Improvement in blood pressure and electronic fetal monitoring during with use of CPAP.
Full Information
NCT ID
NCT00259688
First Posted
November 28, 2005
Last Updated
January 7, 2010
Sponsor
University of Saskatchewan
Collaborators
Saskatchewan Health Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00259688
Brief Title
Prevalence Study of Sleep Apnea in Women With Preeclampsia
Official Title
Sleep Disordered Breathing and Preeclampsia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Saskatchewan
Collaborators
Saskatchewan Health Research Foundation
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
Preeclampsia, Sleep Apnea, CPAP
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
Women with gestational hypertension
Arm Title
2
Arm Type
No Intervention
Arm Description
Women with uncomplicated pregnancies
Arm Title
3
Arm Type
No Intervention
Arm Description
Re-test of women one to two years post-partum.
Intervention Type
Device
Intervention Name(s)
CPAP therapy for subjects diagnosed with sleep apnea
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determine the prevalence of sleep apnea in preeclampsia and pregnancy.
Time Frame
Time of delivery for each woman
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John K Reid, MD, BSc
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal University Hospital Sleep Disorders Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
12. IPD Sharing Statement
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Prevalence Study of Sleep Apnea in Women With Preeclampsia
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