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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-29

Study Completion Date

2024-11-29

Brief Summary

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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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Detailed Description

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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.

Conditions

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Induced Vaginal Delivery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Induction of labour

Cervical Stiffness Assessmenr

Intervention Type 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

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DEVICE

Bishop's Score Assessment

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes