CompletedNot Applicable

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

United Kingdom100 participantsStarted 2023-09-29

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with Vaginal Delivery

Timeframe: 5 days (time of commencing induction of labour to outcome of delivery)

Trial details

NCT IDNCT05981469

SponsorUniversity of Liverpool

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-11-29

View on ClinicalTrials.gov More Induced Vaginal Delivery trials