Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT05981469
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2023-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can Cervical Stiffness Predict Successful Vaginal Delivery After Induction of Labour?
Sponsor:
University of Liverpool
Organization:
Study Overview
Official Title:
Can Cervical Stiffness Predict Successful Vaginal Delivery After Induction of Labour?
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASPAR
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.
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: