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
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.REC name
Wales REC 3
REC reference
23/WA/0044
Date of REC Opinion
3 Mar 2023
REC opinion
Further Information Favourable Opinion