Use of PAP in Women With Pre-eclampsia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Severity of Sleep Disordered Breathing
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Standard care
Positive Airway Pressure (compliant)
This arm was women who used auto-titrating positive airway pressure (APAP) for at least 4 hours per night
Intervention: Positive Airway Pressure (Device)
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.
Intervention: Positive Airway Pressure (Device)
Outcomes
Primary Outcomes
Severity of Sleep Disordered Breathing
Time Frame: 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
Time Frame: baseline and 1 week after PAP treatment.
measured by a 24 hour cuff, averaged across the night;
Number of Participants With Worsening of Hypertension
Time Frame: 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)
Time Frame: Baseline night 1
Presence or absence of SDB (defined as an apnea/hypopnea index; AHI\>=5)
Secondary Outcomes
- Gestational Age at Delivery(At delivery (within 6 months of enrollment).)
- NICU Admission(at delivery (within 6 months of enrollment))
- Birth Weight(At delivery (within 6 months of enrollment))
Investigators
Louise O'Brien
Associate Professor
University of Michigan