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Trial registered on ANZCTR


Registration number
ACTRN12616000934448
Ethics application status
Approved
Date submitted
6/07/2016
Date registered
13/07/2016
Date last updated
4/06/2019
Date data sharing statement initially provided
15/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can shear wave elastography be of value in the assessment of cervical strength for the prediction of preterm birth?
Scientific title
The effectiveness of shear wave elastography in the assessment of cervical strength for the prediction of preterm birth
Secondary ID [1] 289627 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm birth 299413 0
cervix weakness 299414 0
Condition category
Condition code
Reproductive Health and Childbirth 299392 299392 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The maternal cervix will be assessed using shear wave elastography during the fetal morphology scan. This assessment will indicate the strength of the maternal cervix. The shear wave imaging will be performed by Australian Sonographer Accreditation Registry (ASAR) accredited Sonographers under the supervision of Radiologists. The extra assessment of the cervix using shear wave imaging will add up to 10 minutes to the standard ultrasound examination.
The imaging will be performed at the private medical imaging practice of SKG Radiology in Perth, Western Australia. The community branches that will be used for data collection are located at Morley and Rockingham.
Participants will receive a patient information form prior to consenting to be part of the study that they will keep, and a consent form will also be signed.
All Sonographers who are involved in the data collection will receive training prior to commencement. This training will comprise two times two hour sessions. The topics that will be covered will include the physics of shear wave ultrasound presented in a power point format and practical demonstration of the technique. This will take place with small group sessions of less than 10 Sonographers. The training will be conducted by the Sonographer who will lead the data collection for this research, following consultation with the Radiologist leading this research. The sites utilized for training will be at the locations of SKG Radiology Morley and Rockingham. A two hour session will be performed at each site.
Intervention code [1] 295240 0
Diagnosis / Prognosis
Comparator / control treatment
The control group will be the non-pregnant women who are enrolled into the study. The cervical mean cervical strength for the non-pregnant women will be compared to the strength of the pregnant participants.
Control group
Active

Outcomes
Primary outcome [1] 298860 0
Assessment of cervical strength using shear wave ultrasound for non-pregnant women
Timepoint [1] 298860 0
For the non-pregnant participants the shear wave measurements will be registered once during the routing gynaecological examination.
Primary outcome [2] 298861 0
Assessment of cervical strength using shear wave ultrasound for pregnant women
Timepoint [2] 298861 0
For the pregnant participants the shear wave measurements will be registered once during the fetal morphological ultrasound examination.
Primary outcome [3] 298862 0
Assessment of cervical length using ultrasound for pregnant women
Timepoint [3] 298862 0
For the pregnant participants the shear wave measurements will be registered once during the fetal morphological ultrasound examination.
Secondary outcome [1] 325493 0
Gestational age at delivery of fetus for all pregnant women.
The participants will be contacted one time to be asked at what gestation the baby was delivered and the mode of delivery. If the baby was born before 37 weeks of gestation the referring doctor will be contacted to provide details of the delivery.
Timepoint [1] 325493 0
For the pregnant participants the gestational age at which the fetus is delivered will be registered once following the delivery of the fetus.

Eligibility
Key inclusion criteria
Non-pregnant participants
18 to 49 years of age
Varying ethnicity

Pregnant participants:
Cyesis between the Gestations of 16 and 28 weeks gestation
Consent to allowing information on delivery details to be accessed from patient or medical records
Varying gestational status
Varying ethnicity
Minimum age
18 Years
Maximum age
49 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to give consent
Unwilling to give consent
Multiple gestations for pregnant participants
Receiving vaginal progesterone
Current cervical cerclage placement
Previous medical history of hysterectomy for non-pregnant participants

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
For this research data analysis will be performed using SPSS software (SPSS, Chicago, USA).
A p value of less than 0.05 will be considered statistically significant.
This research will have multiple outcomes.
1. Standard stiffness values for the pregnant and non-pregnant cervix in the transabdominal and transvaginal ultrasound approaches will be formulated; this descriptive data will be presented as mean +/- standard deviation.
2. A ‘cut-off’ value between what would be considered a normal cervical stiffness and a reduced cervical stiffness which would indicate an increased risk of preterm birth will be formulated; the accuracy of cervical stiffness, as assessed by both transabdominal and transvaginal techniques, in the prediction of subsequent preterm birth status will be assessed with the use of binary logistic regression modelling.
3. Formulation of a standard ratio between the myometrium and cervix for a strong and soft cervix; this descriptive data will be presented as mean +/- standard deviation.
4. Inter-operator and intra-operator testing will also be performed; the continuous quantitative measures will be performed using the
paired t-test of non-equality.
5. Relevant demographic and medical history of participants will be presented as variables that will also be included in the set of candidate predictors
Estimation of sample size has been performed with consultation from a statistician. A peer reviewed journal article identified a statistically significant difference between the stiffness of cervical tissue in ripened and unripened hysterectomy specimens of the cervix utilising shear wave elastography. The difference between the mean values and the standard deviations of these values were utilised to formulate a sample size using an equation for samples sizes in medical research, a level of significance of p<0.05 was also utilised. Calculations resulted in a requirement of 50 normal (non-pregnant) cervices needing to be compared to 50 soft cervices with cervical ripening indicative of imminent birth. The preterm birth rate in Australia in 2011 was 7.5% of all pregnancies. This rate equates to a ratio of 1:12.33 for babies born preterm to those born at term. This ratio was then used to calculate that for every 667 babies born, there should be 50 that are born preterm. So we expect that 50 babies will be born preterm out of the sample off 667 participants.

Recruitment
Recruitment status
Recruiting
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 in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 13567 0
6062 - Embleton
Recruitment postcode(s) [2] 13568 0
6168 - East Rockingham

Funding & Sponsors
Funding source category [1] 294013 0
Commercial sector/Industry
Name [1] 294013 0
Canon (Australia) Pty Limited Medical Division
Address [1] 294013 0
Bldg C, 12-24 Talavera Rd, NORTH RYDE, 2113 NSW

Country [1] 294013 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 292832 0
Commercial sector/Industry
Name [1] 292832 0
SKG Radiology
Address [1] 292832 0
c/o 3o Ord Street, West Perth, Western Australia, 6005
Country [1] 292832 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295423 0
Human Research Ethics Committee of Curtin University
Ethics committee address [1] 295423 0
Office of Research and Development
Curtin University
7 Parker Place, Building 609. Room 111
Bentley
Western Australia
6102


Ethics committee country [1] 295423 0
Australia
Date submitted for ethics approval [1] 295423 0
23/05/2016
Approval date [1] 295423 0
14/07/2016
Ethics approval number [1] 295423 0
HRE2016-0128

Summary
Brief summary
The main aim of this study is to trial the use of ultrasonic shear wave elastography to test the strength of the maternal cervix during pregnancy. The primary objective of this research is to establish the correlation between cervical stiffness and risk of preterm birth due to reduced cervical strength. This research will have multiple hypotheses. The first being that the cervical stiffness registered in non-gravid participants will be greater than in gravid participants. Secondly participants who deliver at preterm will have a reduced cervical strength compared to women who deliver at term. A further hypothesis is that cervical length will be related to cervical strength, the longer the registered cervical length, the greater the strength of the cervix, and also the cervical strength will be greater than the strength of the myometrium (muscle of the uterus).
Trial website
Trial related presentations / publications
Shear Wave Elastography on the
Uterine Cervix
Technical Development for the Transvaginal Approach
Journal of Ultrasound in Medicine

Shear wave elastography of the maternal cervix:
A transabdominal technique
Australasian Journal of Ultrasound in Medicine
Public notes

Contacts
Principal investigator
Name 67234 0
Prof Zhonghua Sun
Address 67234 0
301.226 (John de Laeter Building)
Curtin University
Kent Street
Bentley
Western Australia
Country 67234 0
Australia
Phone 67234 0
+61 8 9266 7509
Fax 67234 0
+61 8 9266 2377
Email 67234 0
z.sun@curtin.edu.au
Contact person for public queries
Name 67235 0
Ms Sandra O'Hara
Address 67235 0
c/o 30 Ord Street,
West Perth
6005
Country 67235 0
Australia
Phone 67235 0
+61 8 6278 0400
Fax 67235 0
+61 8 9375 1148
Email 67235 0
Sandra.OHara@skg.com.au
Contact person for scientific queries
Name 67236 0
Prof Zhonghua Sun
Address 67236 0
301.226 (John de Laeter Building)
Curtin University
Kent Street
Bentley
Western Australia
Country 67236 0
Australia
Phone 67236 0
+61 8 9266 7509
Fax 67236 0
+61 8 9266 2377
Email 67236 0
z.sun@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results