PRECISION
Research type
Research Study
Full title
Can Cervical Stiffness in the Second Trimester Predict Preterm Birth in High-Risk Singleton Pregnancies?
IRAS ID
316487
Contact name
Andrew Sharp
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 26 days
Research summary
Research 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. We will aim to explore the best possible predictive tool kit bundle for PTB using any combination of these assessments.Summary of Results
Can cervical stiffness in the second trimester predict preterm birth in high-risk singleton pregnancies?
Who carried out this research?
This research was sponsored by the University of Liverpool and undertaken at the Liverpool Women's Hospital, Liverpool, UK over 15 months from July 2023 until October 2024. The principal investigator for this study undertook the role during a position as a Clinical Research Fellow. This position was part funded by Pregnolia. Pregnolia also provided the cervical stiffness device for use throughout the study.
Public involvement in study design
Liverpool Women's Hospital has an active PPI group, Liverpool Babies PPI group. This group was approached to aid with study design including approving study-related written information such as patient information leaflet. Patients within the hospital service where the study would take place were also approached for their opinion on study design. Feedback was collected through anonymous questionnaires and directly informed study design at the time of study protocol writing.
Why was the research needed?
The Pregnolia System is a new, CE-marked, medical device designed to objectively measure cervical stiffness. It has been implemented, in a limited capacity, within obstetric and gynaecology practice in Europe. However, it has not yet been introduced to routine clinical practice within the UK. Its' primary design was intended for use within the preterm birth cohort.
Preterm birth effects 1 in every 12 births in England and Wales each year and can lead to devastating consequences including long term disability or even death. Identifying pregnant women at risk of this obstetric complication can have great impact on improving the long-term outcomes for their child, including survival.
Limited early research using this new device has shown it has potential to identify pregnant women at risk of preterm birth. These findings need to be confirmed in a robust research setting before introduction into routine clinical practice can begin in the UK.
This study was designed to assess key feasibility outcomes to inform whether further definitive studies using this device within preterm birth settings are appropriate and achievable.What happened during the study?
Pregnant women who have already experienced a pregnancy complicated by either early delivery, or waters breaking too early, were approached to take part in the study when they attended for their routine preterm birth clinic appointment. All women attending this service were offered serial cervical length ultrasound scans throughout the second trimester to help guide their further management as per current national guidance. Those who agreed to take part in the study also had an additional assessment using the Pregnolia System to measure their cervical stiffness at the same time as their cervical length scans. Participants completed a questionnaire following the two different cervical stiffness assessments (Pregnolia System and cervical length ultrasound scan) to compare their experience of the two assessments.
All participants of the study continued with management of their pregnancy as per national guidance surrounding cervical length scan results. Data about their pregnancy and delivery were collected from their electronic medical records after they had their baby.Summary of Results
This study found that use of Pregnolia System within a high-risk cohort for preterm birth was feasible in a UK clinical setting.
We were able to establish a recruitment rate of 58% for using this new device within a high-risk cohort in a clinical research setting.
Our results show the pregnant women found the new assessment to be at least as acceptable as current routine assessment using cervical length ultrasound. All participants would agree to a further Pregnolia System assessment in a future pregnancy.
The Pregnolia System was able to provide consistent and reliable measurements in this group of patients. We would advise future studies to take the first reading as their final result for each participant for further analysis.
This feasibility study was not big enough to answer whether this new device can predict risk of early birth in this high-risk group. The incidence of preterm birth in the eligible cohort for the study duration was remarkably low at 3%. However this study data including the recruitment rate, acceptability profile and preterm birth incidence in this cohort, can inform future study design to ensure an appropriately powered definitive study to answer predictive capability of the device can be undertaken.REC name
Wales REC 3
REC reference
23/WA/0044
Date of REC Opinion
3 Mar 2023
REC opinion
Further Information Favourable Opinion