Prevalence Study of Sleep Apnea in Women With Preeclampsia

Preeclampsia Clinical Trial

Official title:

Sleep Disordered Breathing and Preeclampsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259688
• Other study ID #: BIO-REB 05-110
• Status: Completed
• Phase: Phase 2
• First received: November 28, 2005
• Last updated: January 7, 2010
• Start date: February 2006
• Est. completion date: November 2009

Study information

• Verified date: January 2010
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

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.

Locations

Country	Name	City	State
Canada	Royal University Hospital Sleep Disorders Centre	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Saskatchewan Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the prevalence of sleep apnea in preeclampsia and pregnancy.		Time of delivery for each woman	Yes
Secondary	For those subjects diagnoses with sleep apnea: Improvement in blood pressure and electronic fetal monitoring during with use of CPAP.		Time of delivery for each woman	Yes