Prevalence Study of Sleep Apnea in Women With Preeclampsia

This study has been completed.
Sponsor:
Collaborator:
Saskatchewan Health Research Foundation
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00259688
First received: November 28, 2005
Last updated: January 7, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Preeclampsia
Device: CPAP therapy for subjects diagnosed with sleep apnea
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Sleep Disordered Breathing and Preeclampsia

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Determine the prevalence of sleep apnea in preeclampsia and pregnancy. [ Time Frame: Time of delivery for each woman ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2006
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00259688

Locations
Canada, Saskatchewan
Royal University Hospital Sleep Disorders Centre
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Saskatchewan Health Research Foundation
Investigators
Principal Investigator: John K Reid, MD, BSc University of Saskatchewan
  More Information

No publications provided

Responsible Party: John Reid - Assistant Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT00259688     History of Changes
Other Study ID Numbers: BIO-REB 05-110
Study First Received: November 28, 2005
Last Updated: January 7, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Saskatchewan:
Preeclampsia
Sleep Apnea
CPAP

Additional relevant MeSH terms:
Pre-Eclampsia
Sleep Apnea Syndromes
Hypertension, Pregnancy-Induced
Pregnancy Complications
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 14, 2014