Back to resultsStudy of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure
Primary Purpose
Preeclampsia, Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Airway Pressure
Sponsored by
About this trial
This is an interventional treatment trial for Preeclampsia focused on measuring Sleep disordered breathing, Preeclampsia, Positive Airway Pressure
Eligibility 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.
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Experimental
Arm Label
Positive Airway Pressure (compliant)
Standard care
Positive Airway Pressure (non-compliant)
Arm Description
This arm was women who used auto-titrating positive airway pressure (APAP) for at least 4 hours per night
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.
Outcomes
Primary Outcome Measures
Nocturnal Blood Pressure
measured by a 24 hour cuff, averaged across the night;
Number of Participants With Worsening of Hypertension
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
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)
Presence or absence of SDB (defined as an apnea/hypopnea index; AHI>=5)
Secondary Outcome Measures
Gestational Age at Delivery
Birth Weight
NICU Admission
Number of mothers who had one (or more) babies admitted to NICU
Full Information
NCT ID
NCT01029691
First Posted
December 8, 2009
Last Updated
September 14, 2017
Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01029691
Brief Title
Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure
Official Title
Use of PAP in Women With Pre-eclampsia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia, Hypertension
Keywords
Sleep disordered breathing, Preeclampsia, Positive Airway Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positive Airway Pressure (compliant)
Arm Type
Experimental
Arm Description
This arm was women who used auto-titrating positive airway pressure (APAP) for at least 4 hours per night
Arm Title
Standard care
Arm Type
No Intervention
Arm Title
Positive Airway Pressure (non-compliant)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Positive Airway Pressure
Other Intervention Name(s)
PAP
Intervention Description
Women will use positive airway pressure until delivery
Primary Outcome Measure Information:
Title
Nocturnal Blood Pressure
Description
measured by a 24 hour cuff, averaged across the night;
Time Frame
baseline and 1 week after PAP treatment.
Title
Number of Participants With Worsening of Hypertension
Description
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.
Time Frame
1-6 months after enrollment.
Title
Severity of Sleep Disordered Breathing
Description
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.
Time Frame
at baseline
Title
Number of Participants With Sleep-disordered Breathing (SDB)
Description
Presence or absence of SDB (defined as an apnea/hypopnea index; AHI>=5)
Time Frame
Baseline night 1
Secondary Outcome Measure Information:
Title
Gestational Age at Delivery
Time Frame
At delivery (within 6 months of enrollment).
Title
Birth Weight
Time Frame
At delivery (within 6 months of enrollment)
Title
NICU Admission
Description
Number of mothers who had one (or more) babies admitted to NICU
Time Frame
at delivery (within 6 months of enrollment)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise M O'Brien, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24888772
Citation
O'Brien LM, Bullough AS, Chames MC, Shelgikar AV, Armitage R, Guilleminualt C, Sullivan CE, Johnson TR, Chervin RD. Hypertension, snoring, and obstructive sleep apnoea during pregnancy: a cohort study. BJOG. 2014 Dec;121(13):1685-93. doi: 10.1111/1471-0528.12885. Epub 2014 May 30.
Results Reference
result
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Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure
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