Can Cervical Stiffness in the Second Trimester Predict Preterm Birth in High-Risk Singleton Pregnancies?

Summary

Preterm birth (PTB), defined as delivery before 37 weeks gestation, is a common complication of pregnancy and affects up to 1 in 10 women in the UK. PTB is the leading cause of neonatal mortality and morbidity with babies born earliest being at the greatest risk. Identifying women at high risk of having a PTB and offering treatments and intervention to try and prevent this outcome is a huge priority in clinical practice and in government policy.

The PRECISION study will explore the use of a new antenatal test of cervical stiffness to try and improve the recognition of women who may deliver early. Current clinical practice involves measurement of cervical length (CL) and fetal fibronectin in women known to be high risk for PTB. However recent research suggests these methods could be improved upon and we may be able to recognise women at risk more reliably and at an earlier stage in the pregnancy if we use cervical stiffness assessments.

A licensed, CE-marked, vacuum-aspiration device called the Pregnolia system has been developed to give quantitative cervical stiffness index scores during pregnancy. This study will directly compare cervical length measurements and fetal fibronectin results with cervical stiffness, using the Pregnolia system, during the second trimester in women known to be high risk for preterm birth. The investigators will aim to explore the best possible predictive tool kit bundle for PTB using any combination of these assessments.

Conditions

• Preterm Birth

Interventions

DEVICE

Cervical stiffness assessment

The cervical stiffness is assessed by using the licensed, CE-marked Pregnolia System, during a sterile speculum examination. The single-use, sterile Pregnolia Probe is placed on the anterior lip of the cervix at 12 o'clock position and a recording of cervical stiffness is generated over maximum 60 seconds (typically ̴15 seconds) and displayed as Cervical Stiffness Index (CSI) in mbar. The measurement is repeated 3 consecutive times without any time lag.

OTHER

Cervical length measurement

Cervical length measurement will be obtained via transvaginal ultrasound using a GE Voluson E10 ultrasound machine and 7.5MHz transvaginal probe. All measurements will be performed with the woman in a supine position with an empty bladder in the sagittal plane measuring from the internal to external cervical OS. The full length of the cervical canal will be visualized with the closed portion of cervix remaining being measured. Three measurements are taken with the shortest being documented as the final assessment.

OTHER

Fetal fibronectin

Vaginal swab collection. The specimen will be obtained from the posterior fornix over 10 seconds using the polyester tipped swab provided in the Hologic specimen collection kit. This sample will be then be stored frozen and processed using the Rapid fFN 10Q System (HOLOGIC, Marlborough, MA, USA) within 3 months.

Sponsors & Collaborators

• Liverpool Women's NHS Foundation Trust

  collaborator OTHER

• University of Liverpool

  lead OTHER

Principal Investigators

• Andrew Sharp, MBBS,BSc,PhD · University of Liverpool

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-06

Primary Completion

2025-01-31

Completion

2025-02-28

Countries

• United Kingdom

Study Locations