Prevalence Study of Sleep Apnea in Women With Preeclampsia

NCT00259688 | Completed Phase 2

• 1 other identifier: BIO-REB 05-110
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preeclampsia

Keywords

Preeclampsia; Sleep Apnea; CPAP

Outcome Measures

Primary Outcomes (1)

• Determine the prevalence of sleep apnea in preeclampsia and pregnancy.

  Time of delivery for each woman

Secondary Outcomes (1)

• 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

Study Arms (3)

1

NO INTERVENTION

Women with gestational hypertension

2

NO INTERVENTION

Women with uncomplicated pregnancies

Device: CPAP therapy for subjects diagnosed with sleep apnea

3

NO INTERVENTION

Re-test of women one to two years post-partum.

Interventions

CPAP therapy for subjects diagnosed with sleep apnea DEVICE

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women \>18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatchewan Health Research Foundation: collaborator

Study Sites (1)

Royal University Hospital Sleep Disorders Centre

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Pre-Eclampsia; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• John K Reid, MD, BSc

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 28, 2005
• First Posted: November 29, 2005
• Study Start: February 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 8, 2010

Record last verified: 2010-01

Locations

CA (1)