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Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Louise O'Brien, University of Michigan Identifier:
First received: December 8, 2009
Last updated: August 17, 2015
Last verified: August 2015
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of PAP in Women With Pre-eclampsia

Resource links provided by NLM:

Further study details as provided by Louise O'Brien, University of Michigan:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 125
Study Start Date: May 2009
Study Completion Date: May 2015
Primary Completion Date: May 2015 (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


Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01029691

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Louise M O'Brien, PhD University of Michigan
  More Information

Responsible Party: Louise O'Brien, Associate Professor, University of Michigan Identifier: NCT01029691     History of Changes
Other Study ID Numbers: F022873
1K23HL095739-01 ( U.S. NIH Grant/Contract )
Study First Received: December 8, 2009
Last Updated: August 17, 2015

Keywords provided by Louise O'Brien, University of Michigan:
Sleep disordered breathing
Positive Airway Pressure

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications processed this record on September 20, 2017