Study Protocol. The CASPAR study protocol. Can cervical stiffness predict successful vaginal delivery after induction of labour? A feasibility, cohort study.

BackgroundInduction of labour (IOL) is a common obstetric intervention in the UK, affecting up to 33% of deliveries. IOL aims to achieve a vaginal delivery prior to spontaneous onset of labour to prevent harm from ongoing pregnancy complications and is known to prevent stillbirths and reduce neonatal intensive care unit admissions. However, IOL doesnt come without risk and overall, 20% of mothers having an induction will still require a caesarean section birth and in primiparous mothers this rate is even higher. There is no reliable predictive bedside tool available in clinical practice to predict which patients undergoing the IOL process will result in a vaginal birth; the fundamental aim of the IOL process. The Bishops Score (BS) remains in routine clinical practice as the examination tool to assess the cervix prior to IOL, despite it being proven to be ineffective as a predictive tool and largely subjective. This study will assess the use of the Pregnolia System, a new objective antenatal test of cervical stiffness. This study will explore its potential for pre-induction cervical assessment and indication of delivery outcome following IOL. MethodsCASPAR is a feasibility study of term, primiparous women with singleton pregnancies undergoing IOL. Cervical stiffness will be assessed using the Pregnolia System; a novel, non-invasive, licensed, CE-marked, aspiration-based device proven to provide objective, quantitative cervical stiffness measurements represented as the Cervical Stiffness Index (CSI, in mbar). A measurement is obtained by applying the sterile single-use Pregnolia Probe directly to the anterior lip of the cervix, visualised via placement of a speculum. Following informed consent, CASPAR study participants will undergo the Pregnolia System cervical stiffness assessment prior to their IOL process commencing. Participant questionnaires will evaluate the acceptability of this assessment tool in this population. This study will directly compare this novel antenatal test to the current BS for both patient experience of the different cervical assessment tools and for IOL outcome prediction. DiscussionThis feasibility study will explore the use of this novel device in clinical practice for pre-induction cervical assessment and delivery outcome prediction. Our findings will provide novel data that could be instrumental in transforming clinical practice surrounding IOL. Determining recruitment rates and acceptability of this new assessment tool in this population will inform design of a further powered study using the Pregnolia System as the point-of-care, bedside cervical assessment tool within an IOL prediction model. Study registrationThis study is sponsored by The University of Liverpool and registered at ClinicalTrials.gov, identifier NCT05981469, date of registration 7th July 2023.