Induced Vaginal Delivery
Conditions
Keywords
cervical stiffness, induction of labour
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.
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.
Interventions
DEVICECervical 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.
OTHERBishop's Score Assessment
Sterile digital vaginal examination to illicit the Bishop's score (0-12).
Sponsors
Liverpool Women's NHS Foundation Trust
University of Liverpool
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Vaginal Delivery | 5 days (time of commencing induction of labour to outcome of delivery) |
Countries
United Kingdom
Outcome results
None listed