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Trial registered on ANZCTR


Registration number
ACTRN12610000926033
Ethics application status
Approved
Date submitted
20/10/2010
Date registered
1/11/2010
Date last updated
5/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The incidence of persistent pain after Caesarean section and its association with maternal anxiety and socioeconomic background
Scientific title
An Observational study of the incidence of persistent pain after Caesarean section, with pain as measured by the Brief Pain Inventory Questionnaire at 4 months as the primary outcome, and secondary analysis of the relationship of pain with pre-operative anxiety, socioeconomic background, and acute pain.
Secondary ID [1] 252927 0
10/s0709/5 Glasgow Royal Infirmary Ethics registry number
Universal Trial Number (UTN)
U1111-1117-5459
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 258460 0
Condition category
Condition code
Anaesthesiology 258622 258622 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study of persisting pain after Caesarean section up to 4 months after delivery.other parameters being measured are 1. Pre-operative anxiety as measured by the Spielberger State-trait anxiety inventory. 2. Acute post-operative pain as measured by a Visual analogue Scale. 3. Pain at 4 months as measured by the Brief Pain inventory. 4. Post natal depression as measured by the Edinburgh Post natal Depression Score. Additional demographic information will be collated including socio-economic status.
Intervention code [1] 257449 0
Not applicable
Comparator / control treatment
Single cohort observational study with no comparator group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259469 0
Pain scores as measured by the Brief Pain Inventory (short form) at 4 months after delivery. Any pain score above zero using this method will be regarded as indicating persisting pain.
Timepoint [1] 259469 0
Primary outcome measurement takes place at 4 months post delivery.
Secondary outcome [1] 266047 0
Association of pre-operative anxiety as measured by Speilberger anxiety inventory (state and trait tests) with the primary outcome (pain at 4 months)
Timepoint [1] 266047 0
Anxiety scores on day 0 (day of Caesarean section) and pain scores at 4months
Secondary outcome [2] 266048 0
Association of socioeconomic background as measured by the Scottish Index of Multiple Deprivations (based on postal code area of participant) with the primary outcome (pain at 4months)
Timepoint [2] 266048 0
socioeconomic scoring at day 0 and pain scores at 4 months
Secondary outcome [3] 266049 0
Association of acute post-operative pain (as measured by a visual analogue scale) with the primary outcome measure (pain at 4 months)
Timepoint [3] 266049 0
VAS score on day 1 (24hrs post delivery) and pain scores at 4 months

Eligibility
Key inclusion criteria
All women listed for elective caesarean section at the trial unit who are primiparous, have had 1 previous delivery, or have had 2 previous deliveries
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Multiparous women with more than 2 previous deliveries, those with no or limited English reading skills, and those who are unable to give their own legally valid consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 2984 0
United Kingdom
State/province [1] 2984 0

Funding & Sponsors
Funding source category [1] 257900 0
Hospital
Name [1] 257900 0
Glasgow Royal Infirmary
Address [1] 257900 0
84 Castle St.
Glasgow
G4 0SF
Country [1] 257900 0
United Kingdom
Primary sponsor type
Hospital
Name
Glasgow Royal Infirmary
Address
84 Castle St.
Glasgow
G4 0SF
Country
United Kingdom
Secondary sponsor category [1] 257095 0
None
Name [1] 257095 0
Address [1] 257095 0
Country [1] 257095 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259921 0
Research and Ethics Committee
Ethics committee address [1] 259921 0
Glasgow Royal Infirmary
84 Castle st
Glasgow
G4 0SF
Ethics committee country [1] 259921 0
United Kingdom
Date submitted for ethics approval [1] 259921 0
01/06/2010
Approval date [1] 259921 0
01/08/2010
Ethics approval number [1] 259921 0
10/S0709/5

Summary
Brief summary
Despite Caesarean section being a common operation worldwide, little is known about the number of women who experience persisting pain symptoms, or what factors might make persisting pain more likely. Two studies from Scandinavia have suggested 18% of women have such pain problems. These studies were retrospective- looking at a group of women some time after their Caesareans. We plan to observe from before the Caesarean to 4 months afterwards, which will give more robust information. We hope to identify how many women in a UK population have persisting pain problems, and see if we can define any factors which might help is in the future to predict which women are at risk.
Trial website
Trial related presentations / publications
Trial is complete and has been published in the International Journal of Obstetric Anaesthesia. Full citation is:
Daly, B., Young, S., Marla, R., Riddell, L., Junkin, R., Weidenhammer, N., Dolan, J., Kinsella, J. and Zhang, R. (2017) Persistent pain after caesarean section and its association with maternal anxiety and socioeconomic background. International Journal of Obstetric Anesthesia, 29, pp. 57-63. (doi:10.1016/j.ijoa.2016.10.004
Public notes

Contacts
Principal investigator
Name 31810 0
Dr Brenda Daly
Address 31810 0
Department of Anaesthesia
Glasgow Royal Infiramry
84 Castle St
Galsgow
G4 0SF
Country 31810 0
United Kingdom
Phone 31810 0
+44 0141 211 4620
Fax 31810 0
Email 31810 0
brendadaly@nhs.net
Contact person for public queries
Name 15057 0
Dr Dr Steven Young
Address 15057 0
Department of Anaesthesia
Walton Building
Glasgow Royal Infirmary
84 Castle st
Glasgow
G4 0SF
Country 15057 0
United Kingdom
Phone 15057 0
+44 0141 211 4620
Fax 15057 0
Email 15057 0
steven.young@ggc.scot.nhs.uk
Contact person for scientific queries
Name 5985 0
Dr Dr Steven Young
Address 5985 0
Department of Anaesthesia
Walton Building
Glasgow Royal Infirmary
84 Castle st
Glasgow
G4 0SF
Country 5985 0
United Kingdom
Phone 5985 0
+44 0141 211 4620
Fax 5985 0
Email 5985 0
steven.young@ggc.scot.nhs.uk

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary