Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

Not Applicable

Completed

• Conditions: Preeclampsia; Hypertension
• Interventions: Device: Positive Airway Pressure

• Registration Number: NCT01029691
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2009-12-09
• Study First Posted: 2009-12-10
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2017-08-09
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-14
• Last Update Submitted: 2017-09-14
• Results First Posted: 2017-10-16
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive Airway Pressure (compliant)	Positive Airway Pressure	This arm was women who used auto-titrating positive airway pressure (APAP) for at least 4 hours per night
Positive Airway Pressure (non-compliant)	Positive Airway Pressure	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Gestational Age at Delivery	At delivery (within 6 months of enrollment).
NICU Admission	at delivery (within 6 months of enrollment)	Number of mothers who had one (or more) babies admitted to NICU
Birth Weight	At delivery (within 6 months of enrollment)

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States