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Completed

NCT Number: NCT00259688

Prevalence Study of Sleep Apnea in Women With Preeclampsia

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Royal University Hospital Sleep Disorders Centre

Saskatoon, Saskatchewan, S7N 0W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 frame: Time of delivery for each woman

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Saskatchewan Health Research Foundation

Registry information

Official study title

Sleep Disordered Breathing and Preeclampsia

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Nov 29, 2005
Registry last updated
Jan 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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