Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of PAP in Women With Pre-eclampsia

Conditions
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Preeclampsia, Hypertension

Intervention / Treatment
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* Device: Positive Airway Pressure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive Airway Pressure (compliant)<br>This arm was women who used auto-titrating positive airway pressure (APAP) for at least 4 hours per night | Device: Positive Airway Pressure<br>* Women will use positive airway pressure until delivery<br>* Other names: PAP;|
| No Intervention: Standard care<br> | |
| Experimental: Positive Airway Pressure (non-compliant)<br>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<br>* Women will use positive airway pressure until delivery<br>* Other names: PAP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturnal Blood Pressure | measured by a 24 hour cuff, averaged across the night; | baseline and 1 week after PAP treatment. | 
| 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. | 1-6 months after enrollment. | 
| 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. | at baseline | 
| Number of Participants With Sleep-disordered Breathing (SDB) | Presence or absence of SDB (defined as an apnea/hypopnea index; AHI>=5) | Baseline night 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational Age at Delivery |  | At delivery (within 6 months of enrollment). | 
| Birth Weight |  | At delivery (within 6 months of enrollment) | 
| NICU Admission | Number of mothers who had one (or more) babies admitted to NICU | at delivery (within 6 months of enrollment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep disordered breathing, Preeclampsia, Positive Airway Pressure