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

NCT05981469 | Completed

• 1 other identifier: UoL001713
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Induced Vaginal Delivery

Keywords

cervical stiffness; induction of labour

Outcome Measures

Primary Outcomes (1)

• Number of participants with Vaginal Delivery

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

Study Arms (1)

Induction of labour

Device: Cervical Stiffness Assessmenr; Other: Bishop's Score Assessment

Interventions

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.

Induction of labour

Bishop's Score Assessment OTHER

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

Induction of labour

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female of reproductive age with confirmed singleton pregnancy.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants with singleton, term pregnancy, requiring induction of labour.

You may qualify if:

• Age ≥ 18 years
• Being induced
• Singleton pregnancy
• Primiparous
• ≥37+0 weeks gestation
• Intact membranes
• Able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liverpool: lead
• Liverpool Women's NHS Foundation Trust: collaborator

Study Sites (1)

Liverpool Women's Hospital

Liverpool, United Kingdom

Location

Related Publications (1)

• Medford E, Lane S, Merriel A, Sharp A, Care A. The CASPAR study protocol. Can cervical stiffness predict successful vaginal delivery after induction of labour? a feasibility, cohort study. PLoS One. 2025 Jan 16;20(1):e0311324. doi: 10.1371/journal.pone.0311324. eCollection 2025.

  PMID: 39820788 DERIVED

Related Links

• Cervical stiffness assessment device website Available IPD/Information:

Study Officials

• Andrew Sharp

  University of Liverpool

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: September 29, 2023
• Primary Completion: November 29, 2024
• Study Completion: November 29, 2024
• Last Updated: April 22, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)