Preterm BirthPRECISIONNCT05837390
Can Cervical Stiffness in the Second Trimester Predict Preterm Birth in High-Risk Singleton Pregnancies?
An observational study of Preterm Birth, run by University of Liverpool at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Cervical stiffness assessment, Cervical length measurement and Fetal fibronectin
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jul 2023to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited directly from the pre-term birth clinic at the study site.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Women's NHS Foundation Trust
Liverpool, Merseyside, L8 7SS
About this study
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.
Read the detailed description
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.
- Conditions
- Preterm Birth
- Being tested
- Cervical stiffness assessment, Cervical length measurement, Fetal fibronectin
- Keywords
- Preterm birth, Cervical stiffness, cervical integrity
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical stiffness assessmentDevice
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 measurementOther
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 fibronectinOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High risk singleton pregnancy for preterm birth | Not described Receives: Device: Cervical stiffness assessment; Other: Cervical length measurement; Other: Fetal fibronectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Gestation at delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start6 Jul 2023
- Primary completion31 Jan 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool Women's NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Andrew Sharp, MBBS,BSc,PhD, Study director, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837390
- Sponsor's protocol ID
- UoL001714
- Acronym
- PRECISION
- Status last verified
- Mar 2025
- First submitted
- 18 Apr 2023
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39982966
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Cervical Stiffness in the Second Trimester Predict Preterm Birth in High-Risk Singleton Pregnancies?
- ClinicalTrials.gov ID
- NCT05837390
- Acronym / sponsor ID
- PRECISION / UoL001714
- Conditions
- Preterm Birth
- Keywords
- Preterm birth, Cervical stiffness, cervical integrity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Liverpool Women's NHS Foundation Trust
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High risk singleton pregnancy for preterm birth | – | Device: Cervical stiffness assessment, Other: Cervical length measurement, Other: Fetal fibronectin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited directly from the pre-term birth clinic at the study site.
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Singleton pregnancy
- Able to provide informed consent
- Meets criteria for high-risk pre-term birth clinic;
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical stiffness assessmentThe 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. | Device | High risk singleton pregnancy for preterm birth |
| Cervical length measurementCervical 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 | High risk singleton pregnancy for preterm birth |
| Fetal fibronectinVaginal 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. | Other | High risk singleton pregnancy for preterm birth |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Derived from this study: PubMed 39982966Medford 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.
- Cervical stiffness assessment device websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Sharp, MBBS,BSc,PhD study director
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by University of Liverpool at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Spontaneous preterm birth <34 weeks gestation (time frame: Gestation at delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05837390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.