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Can shear wave elastography be of value in the assessment of cervical strength for the prediction of preterm birth?

The effectiveness of shear wave elastography in the assessment of cervical strength for the prediction of preterm birth

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000934448
Enrollment
502
Registered
2016-07-13
Start date
2016-07-20
Completion date
2019-06-28
Last updated
2022-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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 privat

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.

Sponsors

Curtin University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
18 Years to 49 Years
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026