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

Induced Vaginal Delivery Clinical Trial

— CASPAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05981469
• Other study ID #: UoL001713
• Status: Recruiting
• Start date: September 29, 2023
• Est. completion date: November 3, 2024

Study information

• Verified date: April 2024
• Source: University of Liverpool
• Contact: Elizabeth Medford, MBChB, MRCOG
• Phone: 01517089988
• Email: elizabeth.medford1[@]lwh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 3, 2024
• Est. primary completion date: September 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Induced Vaginal Delivery

Intervention

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).

Locations

Country	Name	City	State
United Kingdom	Liverpool Women's Hospital	Liverpool

Sponsors (2)

Lead Sponsor	Collaborator
University of Liverpool	Liverpool Women's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Vaginal Delivery		5 days (time of commencing induction of labour to outcome of delivery)

External Links

•   Cervical stiffness assessment device website Available IPD/Information: