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

Completed

• Conditions: Induced Vaginal Delivery
• Interventions: Device: Cervical Stiffness Assessmenr; Other: Bishop's Score Assessment

• Registration Number: NCT05981469
• Lead Sponsor: University of Liverpool

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-08
• Study Start: 2023-09-29
• Primary Completion: 2024-11-29
• Study Completion: 2024-11-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Induction of labour	Bishop's Score Assessment	-
Induction of labour	Cervical Stiffness Assessmenr	-

Primary Outcome Measures

Name	Time	Method
Number of participants with Vaginal Delivery	5 days (time of commencing induction of labour to outcome of delivery)

Trial Locations

Locations (1)

Liverpool Women's Hospital; 🇬🇧 Liverpool, United Kingdom