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Completed

NCT Number: NCT05837390

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

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Liverpool Women's NHS Foundation Trust

Liverpool, Merseyside, L8 7SS, United Kingdom

About this study

PRECISION is a single site prospective, exploratory, cohort study of 60 women with a singleton pregnancy who are high risk for preterm birth.

Participants will have study assessments at 3 time points in second trimester as part of their routine care in high risk pre-term birth clinic. The study assessments will include transvaginal cervical length scanning, fetal fibronectin swabs and cervical stiffness assessment using the Pregnolia device.

Once recruited, participants will remain in the study until delivery and discharge from hospital. The investigators will collect routine clinical data from all participants' notes and electronic hospital records for maternal and neonatal outcomes. All study visits will coincide with routine care and all participating women will receive routine antenatal care throughout their pregnancy as per Saving Babies Lives Care Bundle V2, NICE Preterm Labour and Birth guideline and the North West Regional network preterm birth guideline.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Number of participants with Spontaneous preterm birth <34 weeks gestation

    Time frame: Gestation at delivery.

    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.

Sponsors and collaborators

Lead sponsor

University of Liverpool

Other

Collaborators

  • Liverpool Women's NHS Foundation Trust

Registry information

Acronym: PRECISION

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 1, 2023
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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