Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

University of Michigan

Status: Completed

Conditions: Hypertension; Preeclampsia

Treatments: Device: Positive Airway Pressure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01029691

1K23HL095739-01 (U.S. NIH Grant/Contract)

F022873

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: Female

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 3 patient groups

Positive Airway Pressure (compliant)

Experimental group

Description:

This arm was women who used auto-titrating positive airway pressure (APAP) for at least 4 hours per night

Treatment:

Device: Positive Airway Pressure

Standard care

No Intervention group

Positive Airway Pressure (non-compliant)

Experimental group

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.

Treatment:

Device: Positive Airway Pressure