Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

Use of PAP in Women With Pre-eclampsia

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Preeclampsia
• Intervention / Treatment: Device: Positive Airway 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 Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Louise M O'Brien, PhD, University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: December 8, 2009
• First Submitted That Met QC Criteria: December 9, 2009
• First Posted (Estimate): December 10, 2009

Study Record Updates

• Last Update Posted (Actual): October 16, 2017
• Last Update Submitted That Met QC Criteria: September 14, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Sleep disordered breathing; Preeclampsia; Positive Airway Pressure
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: F022873; 1K23HL095739-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes