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| Sponsors and Collaborators: |
University of Saskatchewan Saskatchewan Health Research Foundation |
|---|---|
| Information provided by: | University of Saskatchewan |
| ClinicalTrials.gov Identifier: | NCT00259688 |
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 II |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | Sleep Disordered Breathing and Preeclampsia |
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | May 2009 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: No Intervention
Women with gestational hypertension
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2: No Intervention
Women with uncomplicated pregnancies
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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.
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3: No Intervention
Re-test of women one to two years post-partum.
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: John K Reid, MD, BSc | (306) 966- 7594 | reidj@sask.usask.ca |
| Contact: David J Cotton, MD | (306) 966-8299 | david.cotton@saskatoonhealthregion.ca |
| Canada, Saskatchewan | |
| Royal University Hospital Sleep Disorders Centre | Recruiting |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| Contact: John Reid, BSc MD | |
| Principal Investigator: John K Reid, MD, BSc | |
| Principal Investigator: | John K Reid, MD, BSc | University of Saskatchewan |
More Information
| Responsible Party: | University of Saskatchewan ( John Reid - Assistant Professor ) |
| Study ID Numbers: | BIO-REB 05-110 |
| Study First Received: | November 28, 2005 |
| Last Updated: | June 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00259688 |
| Health Authority: | Canada: Ethics Review Committee |
|
Preeclampsia Sleep Apnea CPAP |
|
Hypertension, Pregnancy-Induced Sleep Apnea Syndromes Pregnancy Complications Eclampsia Apnea |
Pregnancy toxemia /hypertension Pre-Eclampsia Preeclampsia Hypertension |
