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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02303834
Registration number
NCT02303834
Ethics application status
Date submitted
25/11/2014
Date registered
1/12/2014
Titles & IDs
Public title
CPAP in Preeclampsia
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Scientific title
Single Blinded Randomised Control Trial of Treatment of Sleep Disordered Breathing in Preeclampsia With Nasal CPAP
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Secondary ID [1]
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HREC 14/092
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Preeclampsia
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Hypertension
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Condition category
Condition code
Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Continuous Positive Airway Pressure Ventilation (CPAP)
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).
Treatment: Devices: Continuous Positive Airway Pressure Ventilation (CPAP)
A mask worn over the nose that delivers air under slight pressure.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Maternal Blood Pressure
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Assessment method [1]
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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.
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Timepoint [1]
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2 days
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Primary outcome [2]
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Fetal movements
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Assessment method [2]
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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.
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Timepoint [2]
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2 days
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2017
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Sample size
Target
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Accrual to date
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Final
5
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal Hospital for Women - Sydney
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Sydney
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Recruitment postcode(s) [1]
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2031 - Sydney
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Recruitment postcode(s) [2]
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2050 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Royal Prince Alfred Hospital, Sydney, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02303834
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Colin Sullivan, MBBS phD
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Address
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University of Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Data is de-identified and analysed as a cohort, no individual data will be published.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02303834