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DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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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?
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Scientific title
How do women cope with pelvic girdle pain in pregnancy?
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Secondary ID [1]
295839
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
pregnancy related pelvic girdle pain
309288
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Condition category
Condition code
Musculoskeletal
308162
308162
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0
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Other muscular and skeletal disorders
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Reproductive Health and Childbirth
308163
308163
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0
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Antenatal care
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
312176
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
307129
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Information about how women feel they cope with pregnancy related pelvic girdle pain collected via semi-structured interview, participant diary and/or focus group
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Assessment method [1]
307129
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Timepoint [1]
307129
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One timepoint only at interview or with diary completion
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Secondary outcome [1]
350775
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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
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Assessment method [1]
350775
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Timepoint [1]
350775
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At one timepoint at focus group session
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Eligibility
Key inclusion criteria
Women over age 18 years and diagnosed with pregnancy related pelvic girdle pain who speak English
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Unable to speak English
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Qualitative analysis will be completed with purposive sampling of participants. Thematic analysis will be completed.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/09/2018
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Actual
1/02/2019
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Date of last participant enrolment
Anticipated
31/01/2021
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Actual
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Date of last data collection
Anticipated
31/01/2021
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Actual
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Sample size
Target
25
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Accrual to date
7
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
23733
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2145 - Westmead
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Funding & Sponsors
Funding source category [1]
300436
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Hospital
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Name [1]
300436
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Westmead Hospital
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Address [1]
300436
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Dragana Ceprnja
Physiotherapy Department
Westmead Hospital
PO BOX 533
Wentworthville NSW 2145
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Country [1]
300436
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Australia
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Primary sponsor type
Hospital
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Name
Westmead Hospital
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Address
PO Box 533
Wentworthville NSW 2145
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Country
Australia
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Secondary sponsor category [1]
299896
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University
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Name [1]
299896
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Western Sydney University
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Address [1]
299896
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Campbelltown Campus
Locked Bag 1797, Penrith, NSW 2751, Australia
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Country [1]
299896
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301237
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Westmead Sydney Local Health District Human Research Ethics Committee (EC00152)
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Ethics committee address [1]
301237
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PO Box 533
Wentworthville NSW 2145
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Ethics committee country [1]
301237
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Australia
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Date submitted for ethics approval [1]
301237
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02/08/2017
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Approval date [1]
301237
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27/11/2017
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Ethics approval number [1]
301237
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AU RED LNR/17/WMEAD/508
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Summary
Brief summary
The aim of the study is to identify how women cope with pelvic girdle pain in pregnancy. Many women complain of pelvic girdle pain in pregnancy and seek information about this condition. Currently there is not much available information about this disorder, particularly in Australian women, and this study aims to address this lack of knowledge. Previous studies have so far found that women need to change their daily activities in order to try and cope. A qualitative design will be used to provide a rich description of the lived experience of women living with pelvic girdle pain in pregnancy via interviews, diary or focus groups.
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Trial website
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Trial related presentations / publications
Ceprnja 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
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Public notes
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Contacts
Principal investigator
Name
86334
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Mrs Dragana Ceprnja
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Address
86334
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Dragana Ceprnja
Physiotherapy department
Westmead Hospital
Po Box 33
Wentworthville NSW 2145
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Country
86334
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Australia
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Phone
86334
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+61418 348 618
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Fax
86334
0
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Email
86334
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[email protected]
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Contact person for public queries
Name
86335
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Mrs Dragana Ceprnja
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Address
86335
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Dragana Ceprnja
Physiotherapy department
Westmead Hospital
Po Box 33
Wentworthville NSW 2145
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Country
86335
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Australia
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Phone
86335
0
+61418 348 618
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Fax
86335
0
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Email
86335
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[email protected]
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Contact person for scientific queries
Name
86336
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Mrs Dragana Ceprnja
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Address
86336
0
Dragana Ceprnja
Physiotherapy department
Westmead Hospital
Po Box 33
Wentworthville NSW 2145
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Country
86336
0
Australia
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Phone
86336
0
+61418 348 618
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Fax
86336
0
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Email
86336
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Transcriptions of individual interviews in full are not anticipated to be made publicly available.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
3594
Study protocol
Ceprnja 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
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
4725
Study results article
Yes
Ceprnja D, Chipchase L, Liamputtong P, Gupta A. "T...
[
More Details
]
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
"This is hard to cope with": the lived experience and coping strategies adopted amongst Australian women with pelvic girdle pain in pregnancy.
2022
https://dx.doi.org/10.1186/s12884-022-04426-3
N.B. These documents automatically identified may not have been verified by the study sponsor.
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