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CPAP in Preeclampsia

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ClinicalTrials.gov Identifier: NCT02303834
Recruitment Status : Terminated (Poor recruitment)
First Posted : December 1, 2014
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Royal Prince Alfred Hospital, Sydney, Australia
Information provided by (Responsible Party):
Professor David Celermajer, University of Sydney

Brief Summary:

Study design:

Single blinded randomised control trial

Planned sample size:

30 (women randomized 2:1 to receive either CPAP or no CPAP)

Objectives:

Primary objective: Assess the effects of nasal CPAP on sleep physiology, 24 blood pressures and fetal movements in pregnant women (24-37 weeks gestation) with preeclampsia.

Secondary objective: Assess baseline sleep physiology, blood pressure control and fetal well-being in pregnant women (24-37 weeks gestation) with preeclampsia by completing sleep studies, 24 hour blood pressure monitors, CO2 monitors, and nocturnal fetal movement and HR monitors.

Study Procedure:

Participants will be recruited from the antenatal ward or high-risk antenatal clinic. Following informed consent participants will be randomly assigned to receive either CPAP or no CPAP for one night, following an initial baseline overnight sleep study.

Baseline- Night 1

  1. Sleep study with fetal movement and HR monitor
  2. 24 hour BP monitor
  3. CO2 monitor

Intervention- Night 2 (Nasal CPAP device or no CPAP)

  1. Sleep study with fetal movement and HR monitor
  2. 24 hour BP monitor
  3. CO2 monitor

Post-partum questionnaire A brief questionnaire to be completed within the first 6 weeks post-partum related to the participant's personal health, their child's birth details and health.


Condition or disease Intervention/treatment Phase
Preeclampsia Hypertension Device: Continuous Positive Airway Pressure Ventilation (CPAP) Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Single Blinded Randomised Control Trial of Treatment of Sleep Disordered Breathing in Preeclampsia With Nasal CPAP
Study Start Date : February 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
The control group will not be fitted with CPAP.
Experimental: CPAP group
The group will wear a CPAP device throughout the night. The mask fits comfortably over the nose and delivers a steady stream of air under slight pressure (auto-set).
Device: Continuous Positive Airway Pressure Ventilation (CPAP)
A mask worn over the nose that delivers air under slight pressure.




Primary Outcome Measures :
  1. Maternal Blood Pressure [ Time Frame: 2 days ]
    Maternal blood pressure will be measured hourly for 48 hours during the 2 days of the study. This will be used to compare average nocturnal and daytime blood pressures between the first and 2nd (intervention) night in the 2 groups.

  2. Fetal movements [ Time Frame: 2 days ]
    Fetal movements will be measured throughout the night for 2 consecutive nights (night 1 and night 2-intervention). This will be used to calculate average fetal movements per hour in each of the 2 groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women 24-37 weeks pregnant
  • Singleton pregnancy
  • Primiparous and primigravid
  • Maternal age 18-45 years
  • Diagnosis of preeclampsia by their treating specialist (SBP>140/90 and proteinuria>300mg in 24 hours)

Exclusion Criteria:

  • A previous diagnosis of hypertension, cardiac, respiratory or renal disease.
  • Any regular cardiac or respiratory medications (PRIOR to pregnancy and diagnosis of preeclampsia)
  • Current smokers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303834


Locations
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Australia, New South Wales
Royal Hospital for Women
Sydney, New South Wales, Australia, 2031
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Sponsors and Collaborators
University of Sydney
Royal Prince Alfred Hospital, Sydney, Australia
Investigators
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Study Chair: Colin Sullivan, MBBS phD University of Sydney
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Responsible Party: Professor David Celermajer, Professor, University of Sydney
ClinicalTrials.gov Identifier: NCT02303834    
Other Study ID Numbers: HREC 14/092
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data is de-identified and analysed as a cohort, no individual data will be published.
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications