Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001423202
Ethics application status
Approved
Date submitted
17/08/2018
Date registered
27/08/2018
Date last updated
3/12/2020
Date data sharing statement initially provided
30/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
How do women cope with pelvic girdle pain in pregnancy?
Scientific title
How do women cope with pelvic girdle pain in pregnancy?
Secondary ID [1] 295839 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy related pelvic girdle pain 309288 0
Condition category
Condition code
Musculoskeletal 308162 308162 0 0
Other muscular and skeletal disorders
Reproductive Health and Childbirth 308163 308163 0 0
Antenatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Interview study which will involve any or all of the following according to patient preference:
structured interview - one to one face to face single interview based on interview guide of open questions of 30 minute duration interviewed by study physiotherapist
and / or participant diary - offered as an alternative or additional form of information collection, participants will be asked to describe in writing their responses to the same interview guide of open questions over a two week period of time
and focus group - all participants will then be offered the opportunity to participate in a focus group of 6-8 people, facilitated by the study physiotherapist, for 60 mins duration with the same interview guide questions used.
Focus groups will be scheduled at two time points - in the middle of the data collection period, and towards the end of the data collection period.
For all methods, the same interview guide will be used, allowing participants to provide responses with different methods to the same questions.
Intervention code [1] 312176 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307129 0
Information about how women feel they cope with pregnancy related pelvic girdle pain collected via semi-structured interview, participant diary and/or focus group
Timepoint [1] 307129 0
One timepoint only at interview or with diary completion
Secondary outcome [1] 350775 0
What supports women may feel they need to cope with pregnancy related pelvic girdle pain as collected by semi-structured interview, participant diary, and/or focus group
Timepoint [1] 350775 0
At one timepoint at focus group session

Eligibility
Key inclusion criteria
Women over age 18 years and diagnosed with pregnancy related pelvic girdle pain who speak English
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to speak English

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Qualitative analysis will be completed with purposive sampling of participants. Thematic analysis will be completed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2018
Actual
1/02/2019
Date of last participant enrolment
Anticipated
31/01/2021
Actual
Date of last data collection
Anticipated
31/01/2021
Actual
Sample size
Target
25
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 23733 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 300436 0
Hospital
Name [1] 300436 0
Westmead Hospital
Country [1] 300436 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
PO Box 533
Wentworthville NSW 2145
Country
Australia
Secondary sponsor category [1] 299896 0
University
Name [1] 299896 0
Western Sydney University
Address [1] 299896 0
Campbelltown Campus
Locked Bag 1797, Penrith, NSW 2751, Australia
Country [1] 299896 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301237 0
Westmead Sydney Local Health District Human Research Ethics Committee (EC00152)
Ethics committee address [1] 301237 0
Ethics committee country [1] 301237 0
Australia
Date submitted for ethics approval [1] 301237 0
02/08/2017
Approval date [1] 301237 0
27/11/2017
Ethics approval number [1] 301237 0
AU RED LNR/17/WMEAD/508

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

Contacts
Principal investigator
Name 86334 0
Mrs Dragana Ceprnja
Address 86334 0
Dragana Ceprnja
Physiotherapy department
Westmead Hospital
Po Box 33
Wentworthville NSW 2145
Country 86334 0
Australia
Phone 86334 0
+61418 348 618
Fax 86334 0
Email 86334 0
Dragana.ceprnja@health.nsw.gov.au
Contact person for public queries
Name 86335 0
Dragana Ceprnja
Address 86335 0
Dragana Ceprnja
Physiotherapy department
Westmead Hospital
Po Box 33
Wentworthville NSW 2145
Country 86335 0
Australia
Phone 86335 0
+61418 348 618
Fax 86335 0
Email 86335 0
Dragana.ceprnja@health.nsw.gov.au
Contact person for scientific queries
Name 86336 0
Dragana Ceprnja
Address 86336 0
Dragana Ceprnja
Physiotherapy department
Westmead Hospital
Po Box 33
Wentworthville NSW 2145
Country 86336 0
Australia
Phone 86336 0
+61418 348 618
Fax 86336 0
Email 86336 0
Dragana.ceprnja@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Transcriptions of individual interviews in full are not anticipated to be made publicly available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3594Study protocolCeprnja D, Chipchase L, Liamputtong P, et al. How do Australian women cope with pelvic girdle pain during pregnancy? A qualitative study protocol. BMJ Open 2018;8:e022332. doi:10.1136/ bmjopen-2018-022332  



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Ceprnja D, Chipchase L, Liamputtong P, Gupta A. "T... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
Embase"This is hard to cope with": the lived experience and coping strategies adopted amongst Australian women with pelvic girdle pain in pregnancy.2022https://dx.doi.org/10.1186/s12884-022-04426-3
N.B. These documents automatically identified may not have been verified by the study sponsor.