Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

University of Michigan125 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

125

Conditions

Preeclampsia Hypertension

Interventions

Positive Airway PressureDEVICE

Women will use positive airway pressure until delivery

Eligibility

Sex: FEMALEMin age: 14 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Nocturnal Blood Pressure

measured by a 24 hour cuff, averaged across the night;

Time frame: 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.

Time frame: 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.

Time frame: at baseline

Number of Participants With Sleep-disordered Breathing (SDB)

Presence or absence of SDB (defined as an apnea/hypopnea index; AHI\>=5)

Time frame: Baseline night 1

Secondary Outcomes

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

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

Time frame: at delivery (within 6 months of enrollment)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.