N/A N=124 Treatment

Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

Preeclampsia · Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01029691 ↗

Enrolled (actual)

124

Serious AEs

2.7%

Results posted

Oct 2017

Primary outcome: Primary: Nocturnal Blood Pressure — 128.2; 124.7; 70.6; 68.8 mmHg — p=0.45

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Positive Airway Pressure (Device)
Age: Pediatric, Adult, Older Adult · 14+ yrs
Sex: Female
Sponsor: University of Michigan
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Nocturnal Blood Pressure	128.2; 124.7; 70.6; 68.8; 127.7; 125.3	0.45
PRIMARY Number of Participants With Worsening of Hypertension	11; 9; 57	0.085
PRIMARY Severity of Sleep Disordered Breathing	15.6; 2.7	0.012 sig
PRIMARY Number of Participants With Sleep-disordered Breathing (SDB)	14; 3	—
SECONDARY Gestational Age at Delivery	36.7; 36.0; 36.9	—
SECONDARY Birth Weight	2804.3; 2749.7; 2957.5	—
SECONDARY NICU Admission	1; 3; 13	0.4

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01029691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.