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

NCT05837390 | Completed

• 1 other identifier: UoL001714
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Preterm birth; Cervical stiffness; cervical integrity

Outcome Measures

Primary Outcomes (1)

• Number of participants with Spontaneous preterm birth <34 weeks gestation

  We will define sPTB as labour having occurred prior to 34+0 weeks of gestation in patients with either intact membranes or PPROM (\<37 weeks). This excludes iatrogenic causes for preterm delivery including induction of labour (in the absence of PPROM) or elective caesarean section.

  Gestation at delivery.

Study Arms (1)

High risk singleton pregnancy for preterm birth

Device: Cervical stiffness assessment; Other: Cervical length measurement; Other: Fetal fibronectin

Interventions

Cervical stiffness assessment DEVICE

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.

High risk singleton pregnancy for preterm birth

Cervical length measurement OTHER

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.

High risk singleton pregnancy for preterm birth

Fetal fibronectin OTHER

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.

High risk singleton pregnancy for preterm birth

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female of reproductive age with confirmed singleton pregnancy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited directly from the pre-term birth clinic at the study site.

You may qualify if:

• Age ≥ 18 years
• Singleton pregnancy
• Able to provide informed consent
• Meets criteria for high-risk pre-term birth clinic;
• Previous PPROM \<34+0 weeks
• Previous sPTB \<34+0 weeks
• Previous spontaneous mid trimester miscarriage \>16 weeks

You may not qualify if:

• Previous cervical surgery including previous trachelectomy, cone biopsy, loop excision or previous cerclage
• Existing cervical cerclage (vaginal or abdominal)
• Any cervical pathology at 12 o'clock position on cervix
• Vaginal bleeding evident on examination
• Visible, symptomatic cervical or vaginal infections
• Symptomatic of preterm birth (SROM, cervical dilatation)
• Known congenital uterine anomalies
• Known or suspected structural/chromosomal fetal abnormality
• Known HIV
• Cervical carcinoma
• Previous fully dilated emergency caesarean section
• Non-English speaking if unable to provide suitable verbal translation services (language line) at the time of recruitment or subsequent study visits.

Sponsors & Collaborators

• University of Liverpool: lead
• Liverpool Women's NHS Foundation Trust: collaborator

Study Sites (1)

Liverpool Women's NHS Foundation Trust

Liverpool, Merseyside, L8 7SS, United Kingdom

Location

Related Publications (1)

• Medford E, Lane S, Sharp A, Care A. The PRECISION study protocol: Can cervical stiffness in the second trimester predict preterm birth in high-risk singleton pregnancies? A feasibility, cohort study. PLoS One. 2025 Feb 21;20(2):e0316297. doi: 10.1371/journal.pone.0316297. eCollection 2025.

  PMID: 39982966 DERIVED

Related Links

• Cervical stiffness assessment device website

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vaginal swabs. Two high vaginal swabs will be obtained as gifted samples for future research. These vaginal swab samples will be stored as part of the LWH tissue bank for 2 years for future exploratory microbiome and metabolome analysis. One vaginal swab for fetal fibronectin assessment will be taken at each study visit (total of three per participant).

MeSH Terms

Conditions

Premature Birth

Interventions

FFN protein, human

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Andrew Sharp, MBBS,BSc,PhD

  University of Liverpool

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 1, 2023
• Study Start: July 6, 2023
• Primary Completion: January 31, 2025
• Study Completion: February 28, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)