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Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

This study is currently recruiting participants.
Verified March 2012 by University of Michigan
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Louise O'Brien, University of Michigan
ClinicalTrials.gov Identifier:
NCT01029691
First received: December 8, 2009
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
PreEclampsia
 Device: Positive Airway Pressure

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of PAP in Women With Pre-eclampsia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Nocturnal blood pressure [ Time Frame: Nocturnal blood pressure is measured at baseline and 1 week after PAP treatment. ] [ Designated as safety issue: No ]
  • Diagnoses of hypertension [ Time Frame: Diagnoses of hypertension are obtained from medical records within 1-6 months after enrollment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gestational age at delivery [ Time Frame: At delivery (within 6 months of enrollment). ] [ Designated as safety issue: No ]
  • Birth weight [ Time Frame: At delivery (within 6 months of enrollment) ] [ Designated as safety issue: No ]
  • NICU admission [ Time Frame: at delivery (within 6 months of enrollment) ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: May 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Positive Airway Pressure Device: Positive Airway Pressure
Women will use positive airway pressure until delivery
Other Name: PAP
No Intervention: Standard care

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with preeclampsia who receive care at the University of Michigan Hospitals
  • Aged at least 14 years old.
  • No current use of PAP therapy.
  • Willing and able to provide informed consent.

Exclusion Criteria:

  • Current PAP therapy
  • Any medical reason why PAP therapy may not be suitable (e.g., in patients with recent head trauma).
  • Cognitively impaired and unable to understand informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029691

Contacts
Contact: Louise M O'Brien, PhD 734-763-9684 louiseo@med.umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Louise M O'Brien, PhD     734-763-9684     louiseo@med.umich.edu    
Sub-Investigator: Ronald D Chervin, MD, MS            
Sub-Investigator: Timothy RB Johnson, MD            
Sponsors and Collaborators
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Louise M O'Brien, PhD University of Michigan
  More Information

No publications provided

Responsible Party: Louise O'Brien, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01029691     History of Changes
Other Study ID Numbers: F022873, 1K23HL095739-01
Study First Received: December 8, 2009
Last Updated: March 6, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Michigan:
Sleep disordered breathing
Preeclampsia
Positive Airway Pressure

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on June 18, 2013