Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000391572
Ethics application status
Not yet submitted
Date submitted
4/09/2006
Date registered
5/09/2006
Date last updated
5/09/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Walking versus Lying to prevent hypotension following spinal anaesthesia for caesarean section
Scientific title
Walking versus Lying to prevent hypotension following spinal anaesthesia for caesarean section: a randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypotension following spinal anaesthesia for caesarean section 1357 0
Condition category
Condition code
Anaesthesiology 1448 1448 0 0
Other anaesthesiology
Cardiovascular 1449 1449 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Walking for 15 minutes or more prior to positioning for spinal anaesthesia
Intervention code [1] 1343 0
Prevention
Comparator / control treatment
Lying down for 15 minutes or more prior to positioning for spinal anaesthesia
Control group
Active

Outcomes
Primary outcome [1] 1999 0
The number of women requiring treatment for hypotension
Timepoint [1] 1999 0
Within 20 minutes of induction of spinal anaesthesia
Secondary outcome [1] 3462 0
1. The number of women requiring treatment for hypotension
Timepoint [1] 3462 0
Within 10 minutes of induction of spinal anaesthesia.
Secondary outcome [2] 3463 0
2. The number of women requiring treatment for hypotension
Timepoint [2] 3463 0
At any time from induction of anaesthesia to delivery of the baby.
Secondary outcome [3] 3464 0
3. The number of women requiring treatment for hypotension
Timepoint [3] 3464 0
At any time from induction of anaesthesia to completion of surgery.
Secondary outcome [4] 3465 0
4. Mean blood pressure
Timepoint [4] 3465 0
Every 5 minutes for 30 minutes after induction of spinal anaesthesia.
Secondary outcome [5] 3466 0
5. Maternal satisfaction score with the intervention
Timepoint [5] 3466 0
Within 4 hours post-operatively.

Eligibility
Key inclusion criteria
>34 weeks gestation, Singleton fetus, scheduled for spinal anesthesia for caesarean section.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-existing hypertension or pre-eclampsia, multiple pregnancy, < 1 hour to scheduled caesarean, Grade 3/4 placenta praevia.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutively numbered opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessor and anaesthetist wil be blinded to the primary outcome and data analyst will be blinded to group allocation for all outcomes
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1586 0
Government body
Name [1] 1586 0
Children, Youth and Women's Health Service
Country [1] 1586 0
Australia
Primary sponsor type
Individual
Name
Dr Allan M Cyna
Address
Country
Secondary sponsor category [1] 1393 0
None
Name [1] 1393 0
N/A
Address [1] 1393 0
Country [1] 1393 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3010 0
CYWHS
Ethics committee address [1] 3010 0
Ethics committee country [1] 3010 0
Australia
Date submitted for ethics approval [1] 3010 0
Approval date [1] 3010 0
Ethics approval number [1] 3010 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27950 0
Address 27950 0
Country 27950 0
Phone 27950 0
Fax 27950 0
Email 27950 0
Contact person for public queries
Name 10532 0
Dr A.M. Cyna
Address 10532 0
Department of Women's Anaesthesia
Women's and Children's Hospital
72 King William Rd
Adelaide SA 5006
Country 10532 0
Australia
Phone 10532 0
+61 8 81617000
Fax 10532 0
Email 10532 0
[email protected]
Contact person for scientific queries
Name 1460 0
Dr A.M. Cyna
Address 1460 0
Department of Women's Anaesthesia
Women's and Children's Hospital
72 King William Rd
Adelaide SA 5006
Country 1460 0
Australia
Phone 1460 0
+61 8 81617000
Fax 1460 0
Email 1460 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTechniques for preventing hypotension during spinal anaesthesia for caesarean section.2020https://dx.doi.org/10.1002/14651858.CD002251.pub4
N.B. These documents automatically identified may not have been verified by the study sponsor.