MedTrace Logo

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

NCT05981469 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-04-22

No results posted yet for this study

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

Interventions

DEVICE

Cervical Stiffness Assessmenr

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.

OTHER

Bishop's Score Assessment

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

Sponsors & Collaborators

  • Liverpool Women's NHS Foundation Trust

    collaborator OTHER

  • University of Liverpool

    lead OTHER

Principal Investigators

  • Andrew Sharp · University of Liverpool

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-29
Primary Completion
2024-11-29
Completion
2024-11-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05981469 on ClinicalTrials.gov