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Completed

NCT Number: NCT01029691

Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

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.

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Key information

Conditions

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

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Positive Airway Pressure

Device

Women will use positive airway pressure until delivery

Other names: PAP

Primary outcomes

  1. Nocturnal Blood Pressure

    Time frame: baseline and 1 week after PAP treatment.

    measured by a 24 hour cuff, averaged across the night;

  2. 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.

  3. 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.

  4. 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

  1. Gestational Age at Delivery

    Time frame: At delivery (within 6 months of enrollment).

  2. Birth Weight

    Time frame: At delivery (within 6 months of enrollment)

  3. NICU Admission

    Time frame: at delivery (within 6 months of enrollment)

    Number of mothers who had one (or more) babies admitted to NICU

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Use of PAP in Women With Pre-eclampsia

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Dec 10, 2009
Registry last updated
Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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