ANZCTR - Registration

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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]

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

Condition category

Condition code

Anaesthesiology

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]

Not applicable

Comparator / control treatment

Single cohort observational study with no comparator group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Primary outcome measurement takes place at 4 months post delivery.

Secondary outcome [1]

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]

Anxiety scores on day 0 (day of Caesarean section) and pain scores at 4months

Secondary outcome [2]

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]

socioeconomic scoring at day 0 and pain scores at 4 months

Secondary outcome [3]

Association of acute post-operative pain (as measured by a visual analogue scale) with the primary outcome measure (pain at 4 months)

Timepoint [3]

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

Sex

Females

Can healthy volunteers participate?

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

1/11/2010

Actual

1/11/2010

Date of last participant enrolment

Anticipated

Actual

3/02/2014

Date of last data collection

Anticipated

Actual

3/02/2014

Sample size

Target

200

Accrual to date

Final

205

Recruitment outside Australia

Country [1]

United Kingdom

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Glasgow Royal Infirmary

Address [1]

84 Castle St.
Glasgow
G4 0SF

Country [1]

United Kingdom

Primary sponsor type

Hospital

Name

Glasgow Royal Infirmary

Address

84 Castle St.
Glasgow
G4 0SF

Country

United Kingdom

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research and Ethics Committee

Ethics committee address [1]

Glasgow Royal Infirmary
84 Castle st
Glasgow
G4 0SF

Ethics committee country [1]

United Kingdom

Date submitted for ethics approval [1]

01/06/2010

Approval date [1]

01/08/2010

Ethics approval number [1]

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

Dr Brenda Daly

Address

Department of Anaesthesia
Glasgow Royal Infiramry
84 Castle St
Galsgow
G4 0SF

Country

United Kingdom

Phone

+44 0141 211 4620

Fax

brendadaly@nhs.net

Contact person for public queries

Name

Dr Steven Young

Address

Department of Anaesthesia
Walton Building
Glasgow Royal Infirmary
84 Castle st
Glasgow
G4 0SF

Country

United Kingdom

Phone

+44 0141 211 4620

Fax

steven.young@ggc.scot.nhs.uk

Contact person for scientific queries

Name

Dr Steven Young

Address

Department of Anaesthesia
Walton Building
Glasgow Royal Infirmary
84 Castle st
Glasgow
G4 0SF

Country

United Kingdom

Phone

+44 0141 211 4620

Fax

steven.young@ggc.scot.nhs.uk

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

Source	Title	Year of Publication	DOI
Embase	Persistent pain after caesarean section and its association with maternal anxiety and socioeconomic background.	2017	https://dx.doi.org/10.1016/j.ijoa.2016.10.004

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically