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Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

NCT ID: NCT01029691

Last Updated: 2017-10-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2015-05-31

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.

Conditions

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Preeclampsia Hypertension

Keywords

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Sleep disordered breathing Preeclampsia Positive Airway Pressure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Positive Airway Pressure (compliant)

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

Group Type EXPERIMENTAL

Positive Airway Pressure

Intervention Type DEVICE

Women will use positive airway pressure until delivery

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Positive Airway Pressure

Intervention Type DEVICE

Women will use positive airway pressure until delivery

Interventions

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Positive Airway Pressure

Women will use positive airway pressure until delivery

Intervention Type DEVICE

Other Intervention Names

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PAP

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.
Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Louise O'Brien

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louise M O'Brien, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 24888772 (View on PubMed)

Other Identifiers

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1K23HL095739-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F022873

Identifier Type: -

Identifier Source: org_study_id