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Prevalence Study of Sleep Apnea in Women With Preeclampsia

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ClinicalTrials.gov Identifier: NCT00259688
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : January 8, 2010
Sponsor:
Collaborator:
Information provided by:

November 28, 2005
November 29, 2005
January 8, 2010
February 2006
October 2009   (Final data collection date for primary outcome measure)
Determine the prevalence of sleep apnea in preeclampsia and pregnancy. [ Time Frame: Time of delivery for each woman ]
Determine the prevalence of sleep apnea in preeclampsia and pregnancy.
Complete list of historical versions of study NCT00259688 on ClinicalTrials.gov Archive Site
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 ]
For those subjects diagnoses with sleep apnea: Improvement in blood pressure and electronic fetal monitoring during with use of CPAP.
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Prevalence Study of Sleep Apnea in Women With Preeclampsia
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.
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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Preeclampsia
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: 1
    Women with gestational hypertension
  • No Intervention: 2
    Women with uncomplicated pregnancies
    Intervention: Device: CPAP therapy for subjects diagnosed with sleep apnea
  • No Intervention: 3
    Re-test of women one to two years post-partum.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2009
October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00259688
BIO-REB 05-110
Not Provided
Not Provided
Not Provided
John Reid - Assistant Professor, University of Saskatchewan
University of Saskatchewan
Saskatchewan Health Research Foundation
Principal Investigator: John K Reid, MD, BSc University of Saskatchewan
University of Saskatchewan
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP