Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

NCT01029691 | Completed Results DMC FDA Device

• 2 other identifiers: F0228731K23HL095739-01
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia; Hypertension

Keywords

Sleep disordered breathing; Preeclampsia; Positive Airway Pressure

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Gestational Age at Delivery

  At delivery (within 6 months of enrollment).

• Birth Weight

  At delivery (within 6 months of enrollment)

• NICU Admission

  at delivery (within 6 months of enrollment)

Study Arms (3)

Positive Airway Pressure (compliant)

EXPERIMENTAL

This arm was women who used auto-titrating positive airway pressure (APAP) for at least 4 hours per night

Device: Positive Airway Pressure

Standard care

NO INTERVENTION

Positive Airway Pressure (non-compliant)

EXPERIMENTAL

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

Interventions

Positive Airway Pressure DEVICE

Women will use positive airway pressure until delivery

Also known as: PAP

Positive Airway Pressure (compliant); Positive Airway Pressure (non-compliant)

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 24888772 RESULT

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

These tables represent full basic analysis of all the participants enrolled without adjustment for confounding variables. Future publications will present more complex subsequent analyses.

Results Point of Contact

• Title: Louise O'Brien
• Organization: University of Michigan

louiseo@med.umich.edu

734 647-9064

Study Officials

• Louise M O'Brien, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 10, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 16, 2017
• Results First Posted: October 16, 2017

Record last verified: 2017-09

Locations

US (1)