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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02303834




Registration number
NCT02303834
Ethics application status
Date submitted
25/11/2014
Date registered
1/12/2014
Date last updated
3/05/2018

Titles & IDs
Public title
CPAP in Preeclampsia
Scientific title
Single Blinded Randomised Control Trial of Treatment of Sleep Disordered Breathing in Preeclampsia With Nasal CPAP
Secondary ID [1] 0 0
HREC 14/092
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preeclampsia 0 0
Hypertension 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maternal Blood Pressure
Timepoint [1] 0 0
2 days
Primary outcome [2] 0 0
Fetal movements
Timepoint [2] 0 0
2 days

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)
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2017
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Hospital for Women - Sydney
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Prince Alfred Hospital, Sydney, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02303834
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colin Sullivan, MBBS phD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02303834