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The purpose of this study is to determine if a new antenatal test of cervical stiffness can be used to predict which patients will have a successful vaginal delivery following an induction of labour. A licensed, CE-marked, vacuum-aspiration device called the Pregnolia system has been developed to give quantitative cervical stiffness index score during pregnancy. The CASPAR study will compare cervical stiffness scores to bishop's scores prior to induction of labour and correlate the results to the outcome of delivery.
CASPAR is a single site prospective, exploratory, cohort study of 100 women with singleton pregnancy undergoing induction of labour at the Liverpool Women's Hospital (LWH). All eligible participants giving written informed consent will be asked to undergo a sterile speculum examination for cervical stiffness assessment, prior to routine vaginal digital examination for Bishop's score assessment. Participants will then proceed with their induction of labour as per the unit policy. Once recruited the participants will remain in the study until after delivery and discharge from hospital for the mother and baby, or 1 month after delivery, whichever comes first. Outcomes will be collected from electronic records.
Age
18 - 50 years
Sex
FEMALE
Healthy Volunteers
Yes
Liverpool Women's Hospital
Liverpool, United Kingdom
Start Date
September 29, 2023
Primary Completion Date
November 29, 2024
Completion Date
November 29, 2024
Last Updated
April 22, 2025
100
ACTUAL participants
Cervical Stiffness Assessmenr
DEVICE
Bishop's Score Assessment
OTHER
Lead Sponsor
University of Liverpool
Collaborators
Data Source & Attribution
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