Clinical Trial: Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Use of PAP in Women With Pre-eclampsia

Brief Summary: The purpose of this study is to identify whether sleep-disordered breathing - as measured by overnight polysomnography - is associated with pre-eclampsia and to determine whether use of positive airway pressure can improve nocturnal blood pressure.

Detailed Summary:
Sponsor: University of Michigan

Current Primary Outcome:

  • Nocturnal blood pressure [ Time Frame: Nocturnal blood pressure is measured at baseline and 1 week after PAP treatment. ]
  • Diagnoses of hypertension [ Time Frame: Diagnoses of hypertension are obtained from medical records within 1-6 months after enrollment. ]


Original Primary Outcome: Nocturnal blood pressure and diagnosis of hypertension. [ Time Frame: Nocturnal blood pressure is measured at baseline and 1 week after PAP treatment. Diagnoses of hypertension are obtained from medical records within 1-6 months after enrollment. ]

Current Secondary Outcome:

  • Gestational age at delivery [ Time Frame: At delivery (within 6 months of enrollment). ]
  • Birth weight [ Time Frame: At delivery (within 6 months of enrollment) ]
  • NICU admission [ Time Frame: at delivery (within 6 months of enrollment) ]


Original Secondary Outcome: Delivery outcomes [ Time Frame: At delivery (within 6 months of enrollment). ]

Information By: University of Michigan

Dates:
Date Received: December 8, 2009
Date Started: May 2009
Date Completion:
Last Updated: August 17, 2015
Last Verified: August 2015