Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000701820
Ethics application status
Approved
Date submitted
22/06/2012
Date registered
2/07/2012
Date last updated
3/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Leg swelling after caesarean section
Scientific title
Observational study of the degree of leg swelling after elective caesarean section in healthy parturients
Secondary ID [1] 280724 0
Nil
Universal Trial Number (UTN)
U1111-1132-0519
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leg oedema 286770 0
Complications of caesarean section 286812 0
Condition category
Condition code
Reproductive Health and Childbirth 287078 287078 0 0
Childbirth and postnatal care
Surgery 287123 287123 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of the degree of leg swelling over a 24 hour period from immediately prior to caesarean section
Intervention code [1] 285147 0
Not applicable
Comparator / control treatment
Patients will be their own controls, with a comparison between measurements before and after caesarean section
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287401 0
Change in leg volume at 24 hours after compared to immediately prior to caesarean section, as measured by water displacement volumetry
Timepoint [1] 287401 0
24 hour period
Secondary outcome [1] 298068 0
Change in leg volume at 6 hours as measured by water displacement volumetry
Timepoint [1] 298068 0
6 hours
Secondary outcome [2] 298069 0
Comparison of potential causes of a change in leg swelling with the changes in leg swelling observed, by recording suspected influences of volume change such as parity, previous delivery experiences, fluid administered or taken, etc
Timepoint [2] 298069 0
6 to 24 hours

Eligibility
Key inclusion criteria
Elective caesarean section under spinal anaesthesia in healthy parturients at Christchurch Women's Hospital during the study period
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to give informed consent, BMI > 40, Preeclampsia, Diabetes, ASA 3, 4 or 5, Leg injury or DVT, repeat anaesthetic technique required, discharge prior to followup, gestational age < 37 weeks

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 4378 0
New Zealand
State/province [1] 4378 0

Funding & Sponsors
Funding source category [1] 285506 0
Self funded/Unfunded
Name [1] 285506 0
Daniel Mattingley
Country [1] 285506 0
New Zealand
Primary sponsor type
Individual
Name
Daniel Mattingley
Address
C/O Christchurch Public Hospital
Anaesthetic Department
Riccarton Ave
Christchurch 8011
Country
New Zealand
Secondary sponsor category [1] 284346 0
None
Name [1] 284346 0
Address [1] 284346 0
Country [1] 284346 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287521 0
Multiregion ethics committee
Ethics committee address [1] 287521 0
Ethics committee country [1] 287521 0
New Zealand
Date submitted for ethics approval [1] 287521 0
13/04/2012
Approval date [1] 287521 0
18/04/2012
Ethics approval number [1] 287521 0
MEC/12/EXP/054

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

Contacts
Principal investigator
Name 34355 0
Address 34355 0
Country 34355 0
Phone 34355 0
Fax 34355 0
Email 34355 0
Contact person for public queries
Name 17602 0
Daniel Mattingley
Address 17602 0
C/O Christchurch Public Hospital
Anaesthetic Department
Riccarton Ave
Christchurch 8011
Country 17602 0
New Zealand
Phone 17602 0
+64 3 364 0640
Fax 17602 0
Email 17602 0
[email protected]
Contact person for scientific queries
Name 8530 0
Daniel Mattingley
Address 8530 0
C/O Christchurch Public Hospital
Anaesthetic Department
Riccarton Ave
Christchurch 8011
Country 8530 0
New Zealand
Phone 8530 0
+64 3 364 0640
Fax 8530 0
Email 8530 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
No additional documents have been identified.