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Clinical Trials/NCT00757718
NCT00757718
Completed
Not Applicable

Sleep Disordered Breathing and Gestational Hypertension

University of Saskatchewan1 site in 1 country26 target enrollmentDecember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Disordered Breathing
Sponsor
University of Saskatchewan
Enrollment
26
Locations
1
Primary Endpoint
Effectiveness of the two treatment arms at treating sleep disordered breathing.
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

Sleep disordered breathing (SDB) is a common problem in the adult population. By conservative estimates, 4% of the adult female population has SDB. SDB is a recognized cause of hypertension and treating SDB can improve blood pressure control in people with hypertension. More recently, research efforts have looked at SDB as a possible cause of pregnancy induced hypertension (PIH), a condition which complicates 10% of pregnancies. Traditionally, the best way to assess SDB required patients to spend a night sleeping in the Sleep Laboratory. This is inconvenient and for pregnant women often impossible to arrange, considering the short time frame that exists between time of PIH diagnosis and eventual delivery. Researchers at the University of Saskatchewan are now looking at whether an adequate sleep assessment can be performed at the bedside - either in a patient's home or on the hospital ward. The researchers will also look at different treatment options for sleep apnea, to see if these can improve blood pressure control in this patient population, and delay the need for early delivery. The information from this study may result in a detailed sleep assessment becoming part of the complete assessment of women with PIH. There is an association between sleep disordered breathing (SDB) and gestational hypertension (GHTN). Treatment for the SDB may represent an effective addition to the management of the cardiovascular and metabolic perturbations of GHTN We plan to assess women whether treating SDB with one of two methods will improve the management of GHTN. We will also assess if one method is more effective than the other.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
July 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Women with singleton pregnancies who have the diagnosis of gestational hypertension.

Exclusion Criteria

  • Inability to comply with study parameters
  • Delivery expected within 48 hours

Outcomes

Primary Outcomes

Effectiveness of the two treatment arms at treating sleep disordered breathing.

Time Frame: single night

Secondary Outcomes

  • Effectiveness of the treatment arms at improving metabolic perturbations of GHTN.(single night)
  • Acceptability of therapy(single night)

Study Sites (1)

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