Can Cervical Stiffness Predict Successful Vaginal Delivery After Induction of Labour?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Can Cervical Stiffness Predict Successful Vaginal Delivery After Induction of Labour?

Conditions
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Induced Vaginal Delivery

Intervention / Treatment
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* Device: Cervical Stiffness Assessmenr
* Other: Bishop's Score Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Being induced Singleton pregnancy Primiparous ≥37+0 weeks gestation Intact membranes Able to provide informed consent Exclusion criteria: Previous cervical surgery Any cervical pathology at 12 o'clock position on cervix Vaginal bleeding evident on examination Visible, symptomatic cervical or vaginal infections Known congenital uterine anomalies Known or suspected structural/chromosomal fetal abnormality Known HIV Cervical carcinoma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Induction of labour<br> | Device: Cervical Stiffness Assessmenr<br>* The cervical stiffness is assessed by using the licensed, CE-marked Pregnolia System, during a sterile speculum examination. The single-use, sterile Pregnolia Probe is placed on the anterior lip of the cervix at 12 o'clock position and a recording of cervical stiffness is generated over maximum 60 seconds (typically ̴15 seconds) and displayed as Cervical Stiffness Index (CSI) in mbar. The measurement is repeated 3 consecutive times without any time lag.<br>Other: Bishop's Score Assessment<br>* Sterile digital vaginal examination to illicit the Bishop's score (0-12).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Vaginal Delivery |  | 5 days (time of commencing induction of labour to outcome of delivery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical stiffness, induction of labour