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

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.

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Key information

Conditions

Induced Vaginal Delivery

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Liverpool Women's Hospital

Liverpool, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervical Stiffness Assessmenr

Device

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.

Bishop's Score Assessment

Other

Sterile digital vaginal examination to illicit the Bishop's score (0-12).

Primary outcomes

Number of participants with Vaginal Delivery

Time frame: 5 days (time of commencing induction of labour to outcome of delivery)

Sponsors and collaborators

Lead sponsor

University of Liverpool

Other

Collaborators

Liverpool Women's NHS Foundation Trust

Registry information

Acronym: CASPAR

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Aug 8, 2023
Registry last updated: Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed