Clinical Trial: Sleep Disordered Breathing and Gestational Hypertension

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Sleep Disordered Breathing and Gestational Hypertension

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.

Detailed Summary:
Sponsor: University of Saskatchewan

Current Primary Outcome: Effectiveness of the two treatment arms at treating sleep disordered breathing. [ Time Frame: single night ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Effectiveness of the treatment arms at improving metabolic perturbations of GHTN. [ Time Frame: single night ]
  • Acceptability of therapy [ Time Frame: single night ]


Original Secondary Outcome: Same as current

Information By: University of Saskatchewan

Dates:
Date Received: September 22, 2008
Date Started: December 2008
Date Completion:
Last Updated: September 4, 2009
Last Verified: September 2009