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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - 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.
Timepoint [1] 0 0
2 days
Primary outcome [2] 0 0
Fetal movements - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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/show/NCT02303834