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Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01029691
First Posted: December 10, 2009
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Louise O'Brien, University of Michigan
  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 Hypertension 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: baseline and 1 week after PAP treatment. ]
    measured by a 24 hour cuff, averaged across the night;

  • Number of Participants With Worsening of Hypertension [ Time Frame: 1-6 months after enrollment. ]
    This outcome measure's purpose was to look at the impact of the APAP on blood pressure. This was done categorically by looking at worsening of hypertension with or without escalation of antihypertensive medications.

  • Severity of Sleep Disordered Breathing [ Time Frame: at baseline ]
    Severity of sleep disordered breathing, using the apnea/hypopnea index (number of respiratory evens per hour of sleep), among participants who have or do not have nocturnal hypertension. Obstructive sleep apnea is typically considered present if the AHI is at least 5.

  • Number of Participants With Sleep-disordered Breathing (SDB) [ Time Frame: Baseline night 1 ]
    Presence or absence of SDB (defined as an apnea/hypopnea index; AHI>=5)


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) ]
    Number of mothers who had one (or more) babies admitted to NICU


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 (compliant)
This arm was women who used auto-titrating positive airway pressure (APAP) for at least 4 hours per night
Device: Positive Airway Pressure
Women will use positive airway pressure until delivery
Other Name: PAP
No Intervention: Standard care
Experimental: Positive Airway Pressure (non-compliant)
No one was assigned to this arm, but for results data quality purposes, women assigned to PAP who were explicitly non-compliant (used less than 4 hours per night), were analyzed separately from women who were compliant with the PAP assignment.
Device: Positive Airway Pressure
Women will use positive airway pressure until delivery
Other Name: PAP

Detailed Description:
Initial enrollment began with only women with a pre-existing diagnosis of pre-eclampsia. Part way through the study, IRB granted approval to expand recruitment to include other hypertensive diagnoses. So, in effect, a more accurate post hoc title would be Study of Positive Airway Pressure to Reduce Blood Pressure in Hypertensive Pregnancies.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Women with preeclampsia who receive care at the University of Michigan Hospitals
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029691


Locations
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)
Investigators
Principal Investigator: Louise M O'Brien, PhD University of Michigan
  More Information

Publications:
Responsible Party: Louise O'Brien, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01029691     History of Changes
Other Study ID Numbers: F022873
1K23HL095739-01 ( U.S. NIH Grant/Contract )
First Submitted: December 8, 2009
First Posted: December 10, 2009
Results First Submitted: August 9, 2017
Results First Posted: October 16, 2017
Last Update Posted: October 16, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

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

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