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

University of Liverpool

Status: Completed

Conditions: Induced Vaginal Delivery

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

Study type: Observational

Funder types: Other

Identifiers

NCT05981469

UoL001713

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Induction of labour

Treatment:

Device: Cervical Stiffness Assessmenr

Other: Bishop's Score Assessment