CASPAR
Research type
Research Study
Full title
Can Cervical Stiffness Predict Successful Vaginal Delivery After Induction of Labour?
IRAS ID
316356
Contact name
Andrew Sharp
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
Induction of labour (IOL) is a medical intervention in pregnant women to bring forward the onset of labour and delivery compared to awaiting spontaneous events. This is a common part of modern obstetric practice with over a third of deliveries in England being induced for a variety of clinical reasons. However, IOL does not come without risks and at present there is no reliable predictive indicator to inform the doctors and the patients whether the IOL process will successfully lead to the intended vaginal delivery outcome. In fact, 1 in 5 women who have had an induction will then require an unplanned caesarean section which has additional maternal and neonatal risks.
At present, assessment of the cervix prior to IOL is completed by a digital vaginal examination which produces a Bishop’s score based on different qualities of the cervix from palpation. The higher the score the more successful the induction of labour process is expected to be. In recent studies this method of assessment has been proven to be subjective and a poor predictor of outcome.
New interest in cervical stiffness has led to the development of a licensed, CE-marked, vacuum-aspiration device called the Pregnolia system. In preliminary studies it’s been shown to provide an objective quantitative assessment of the cervix, suggested to be superior to digital palpation techniques.
This study will explore whether the Pregnolia system can be used as a predictive tool for the success of induction of labour in achieving a vaginal delivery and improve upon the current routine practice of Bishop’s score assessments.
Developing an effective predictive assessment for IOL has the potential to transform maternity service planning, as well as provided women and clinicians with more robust information to allow more informed decisions surrounding their care at the time of IOL.
REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0627
Date of REC Opinion
17 Jul 2023
REC opinion
Favourable Opinion