Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259688
Status:
COMPLETED
Last Update Posted:
2010-01-08
First Post:
2005-11-28
Brief Title:
Prevalence Study of Sleep Apnea in Women With Preeclampsia
Sponsor:
University of Saskatchewan
Organization:
University of Saskatchewan
Study Overview
Official Title:
Sleep Disordered Breathing and Preeclampsia
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypothesis The prevalence of sleep apnea is greater in pregnant women with preeclampsia than in pregnant women without preeclampsiaThe 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None