Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 August 21, 2014