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

Further study details as provided by University of Saskatchewan:

Primary Outcomes: Determine the prevalence of sleep apnea in preeclampsia and pregnancy.
Secondary Outcomes: For those subjects diagnoses with sleep apnea: Improvement in blood pressure and electronic fetal monitoring during with use of CPAP.
Expected Total Enrollment:  60

Sleep apnea is common in the adult population. In middle aged men, the presence of sleep apnea has been corrrelated with hypertension, cardiovascular disease and mood disoreders. 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 continous 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00259688

John K Reid, MD, BSc      (306) 966- 7594    reidj@sask.usask.ca
David J Cotton, MD      (306) 966-8299    david.cotton@saskatoonhealthregion.ca

Canada, Saskatchewan
      Royal University Hospital Sleep Disorders Centre, Saskatoon,  Saskatchewan,  S7N 0W8,  Canada

Study chairs or principal investigators

John K Reid, MD, BSc,  Principal Investigator,  University of Saskatchewan   

Study ID Numbers:  BIO-REB 05-110
Last Updated:  December 8, 2005
Record first received:  November 28, 2005
ClinicalTrials.gov Identifier:  NCT00259688
Health Authority: University of Saskatchewan, Canada:
ClinicalTrials.gov processed this record on 2006-01-10