Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000904370
Ethics application status
Approved
Date submitted
5/06/2017
Date registered
20/06/2017
Date last updated
24/04/2020
Date data sharing statement initially provided
17/05/2019
Date results information initially provided
24/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Prevalence of pregnancy related pelvic girdle pain and associated factors in Western Sydney: a cross-sectional study.
Scientific title
Prevalence of pregnancy related pelvic girdle pain and associated factors in Western Sydney: a cross-sectional study.
Secondary ID [1] 292122 0
None
Universal Trial Number (UTN)
U1111-1197-4846
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy related pelvic girdle pain 303550 0
Condition category
Condition code
Reproductive Health and Childbirth 302959 302959 0 0
Antenatal care
Musculoskeletal 303018 303018 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Point prevalence of pregnancy related pelvic girdle pain. We will be assessing the presentation to determine if they can be classified as having PPGP based on self - reported location of pain, reported aggravating factors, and a physical examination. Physical examination will consist of four tests being the Active Straight Leg Raise test, the Poster Pelvic Pain Provocation test, modified Trendelenberg and palpation of long dorsal ligament. Participants will be assesses at one timepoint only, at enrolment of study. The duration of assessment, including completion of all questionnaires is expected to be 45 minutes.
Intervention code [1] 298316 0
Diagnosis / Prognosis
Comparator / control treatment
No control group. However the outcomes from the full standard assessment procedure of the four tests will be statistically compared to the outcome from only one of the four tests (the Modified Trendelenberg test) to investigate whether performing only one test would give the same outcomes as performing all four tests.
Control group
Active

Outcomes
Primary outcome [1] 302351 0
Prevalence of Pregnancy related pelvic girdle pain. Classification of PPGP will be made via self- report, location of pain, reported aggravating activities and a physical examination including the Poster Pelvic Pain Provocation test, Active Straight Leg Raise test, Modified trendelenberg test and palpation of long dorsal sacro-iliac ligament.
Timepoint [1] 302351 0
Cross sectional study. Participants will only be assessed at one time point, upon enrolment into the study.
Secondary outcome [1] 336062 0
Accuracy of a simplified assessment procedure (which consists of the Modified Trendeleneberg test only) in comparison to the standard assessment procedure (which consists of the full set of tests including self-reported location of pain, reported aggravating factors, and a physical examination comprising of the Active Straight Leg Raise test, the Posterior Pelvic Pain Provocation test, the Modified Trendelenberg test and palpation of long dorsal ligament).
Timepoint [1] 336062 0
Measured at one time point only, upon enrolment into the study

Eligibility
Key inclusion criteria
Being pregnant, over 18 years of age, between 14 and 38 weeks gestation attending Westmead Hospital, Sydney, New South Wales, for ante-natal care, and sufficient command of the English language in order to be able to complete questionnaire data or have access to a health care interpreter to be included in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any medical or obstetric complication(s) which affects pregnancy, such as any serious pathology of non-musculoskeletal origin, and gestation beyond 38 weeks.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
The sample size required is 770 to achieve statistical power. 95% CI for estimated prevalence will be no wider than +/- 5% with 770 participants. Using G*Power sample size calculator, assuming independent samples t-test (2-tailed) with 90% power and alpha=0.05 significance level, this study is powered to detect a 0.34 standard deviation difference in means between the two groups (those with PPGP and those without PPGP).
1. Prevalence of PPGP will be determined by calculating the absolute frequency of women classified with PPGP relative to all women recruited to participate in this study.
2. Prevalence rates will be modelled according to gestational age with logistic regression analysis.
3. Associated factors, such as age, parity, gestational age, education status, marital status, physical activity level, ethnicity and pain, will be identified with appropriate parametric comparisons between the two groups (women with PPGP and women without PPGP). Categorical variables will be compared across the two groups using Chi Square test or Fishers test to detect if there is a statistically significant difference between groups of women with and without PPGP. For continuous variables the student t-test will be used to detect if there is a statistically significant difference between groups of women with and without PPGP. Multiple logistic regression analyses will be used to identify the independent predictors of PPGP.
4. The relationship between a simplified assessment procedure and standard assessment procedure will be examined using Kappa reliability or McNemar test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2017
Actual
1/02/2018
Date of last participant enrolment
Anticipated
1/08/2019
Actual
1/10/2019
Date of last data collection
Anticipated
1/08/2019
Actual
1/10/2019
Sample size
Target
770
Accrual to date
Final
780
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8283 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 16343 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 296658 0
Hospital
Name [1] 296658 0
Westmead Hospital
Country [1] 296658 0
Australia
Funding source category [2] 296702 0
University
Name [2] 296702 0
Western Sydney University
Country [2] 296702 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
PO Box 533, WENTWORTHVILLE NSW 2145
Country
Australia
Secondary sponsor category [1] 295615 0
University
Name [1] 295615 0
Western Sydney University
Address [1] 295615 0
Locked Bag 1797, PENRITH NSW 2751
Country [1] 295615 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297884 0
Westmead Hospital
Ethics committee address [1] 297884 0
PO Box 533, WENTWORTHVILLE NSW 2145
Ethics committee country [1] 297884 0
Australia
Date submitted for ethics approval [1] 297884 0
15/02/2017
Approval date [1] 297884 0
05/05/2017
Ethics approval number [1] 297884 0
HREC/17/WMEAD/64

Summary
Brief summary
The primary aim of this study is to determine the prevalence of PPGP in women attending Westmead Hospital for ante-natal care. The secondary aim is to identify factors associated with PPGP. The third aim is to determine the accuracy of a simplified assessment procedure for classification of PPGP compared to standard assessment procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75362 0
Mrs Dragana Ceprnja
Address 75362 0
Physiotherapy Department, Westmead Hospital, PO Box 533, WENTWORTHVILLE NSW 2145
Country 75362 0
Australia
Phone 75362 0
+61 2 9845 6500
Fax 75362 0
Email 75362 0
[email protected]
Contact person for public queries
Name 75363 0
Mrs Dragana Ceprnja
Address 75363 0
Physiotherapy Department, Westmead Hospital, PO Box 533, WENTWORTHVILLE NSW 2145
Country 75363 0
Australia
Phone 75363 0
+61 2 9845 6500
Fax 75363 0
Email 75363 0
[email protected]
Contact person for scientific queries
Name 75364 0
Mrs Dragana Ceprnja
Address 75364 0
Physiotherapy Department, Westmead Hospital, PO Box 533, WENTWORTHVILLE NSW 2145
Country 75364 0
Australia
Phone 75364 0
+ 61 2 9845 6500
Fax 75364 0
Email 75364 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbasePrevalence of pregnancy-related pelvic girdle pain and associated factors in Australia: A cross-sectional study protocol.2017https://dx.doi.org/10.1136/bmjopen-2017-018334
N.B. These documents automatically identified may not have been verified by the study sponsor.