Induced Vaginal DeliveryCASPARNCT05981469
Can Cervical Stiffness Predict Successful Vaginal Delivery After Induction of Labour?
An observational study of Induced Vaginal Delivery, run by University of Liverpool at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Vaginal Delivery
- What is being tested?
- Cervical Stiffness Assessmenr and Bishop's Score Assessment
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Sep 2023to 29 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants with singleton, term pregnancy, requiring induction of labour.
Who may be able to join
- Age ≥ 18 years
- Being induced
- Singleton pregnancy
- Primiparous
- ≥37+0 weeks gestation
- Intact membranes
- Able to provide informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Induced Vaginal Delivery
- Being tested
- Cervical Stiffness Assessmenr, Bishop's Score Assessment
- Keywords
- cervical stiffness, induction of labour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Stiffness AssessmenrDevice
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 AssessmentOther
Sterile digital vaginal examination to illicit the Bishop's score (0-12).
| Study group | Role | What they receive |
|---|---|---|
| Induction of labour | Not described Receives: Device: Cervical Stiffness Assessmenr; Other: Bishop's Score Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Vaginal Delivery
Measured: 5 days (time of commencing induction of labour to outcome of delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start29 Sep 2023
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Induced Vaginal DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool Women's NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Andrew Sharp, Study director, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981469
- Sponsor's protocol ID
- UoL001713
- Acronym
- CASPAR
- Status last verified
- Mar 2025
- First submitted
- 31 Jul 2023
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Medford E, Lane S, Merriel A, Sharp A, Care A. The CASPAR study protocol. Can cervical stiffness predict successful vaginal delivery after induction of labour? a feasibility, cohort study. PLoS One. 2025 Jan 16;20(1):e0311324. doi: 10.1371/journal.pone.0311324. eCollection 2025.
PubMed 39820788
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Cervical Stiffness Predict Successful Vaginal Delivery After Induction of Labour?
- ClinicalTrials.gov ID
- NCT05981469
- Acronym / sponsor ID
- CASPAR / UoL001713
- Conditions
- Induced Vaginal Delivery
- Keywords
- cervical stiffness, induction of labour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Liverpool Women's NHS Foundation Trust
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction of labour | – | Device: Cervical Stiffness Assessmenr, Other: Bishop's Score Assessment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants with singleton, term pregnancy, requiring induction of labour.
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Being induced
- Singleton pregnancy
- Primiparous
- ≥37+0 weeks gestation
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical Stiffness AssessmenrThe 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. | Device | Induction of labour |
| Bishop's Score AssessmentSterile digital vaginal examination to illicit the Bishop's score (0-12). | Other | Induction of labour |
Primary outcome
Number of participants with Vaginal Delivery
Time frame: 5 days (time of commencing induction of labour to outcome of delivery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Derived from this study: PubMed 39820788Medford E, Lane S, Merriel A, Sharp A, Care A. The CASPAR study protocol. Can cervical stiffness predict successful vaginal delivery after induction of labour? a feasibility, cohort study. PLoS One. 2025 Jan 16;20(1):e0311324. doi: 10.1371/journal.pone.0311324. eCollection 2025.
- Cervical stiffness assessment device website Available IPD/Information:Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Sharp study director
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Induced Vaginal Delivery, run by University of Liverpool at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Vaginal Delivery (time frame: 5 days (time of commencing induction of labour to outcome of delivery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05981469, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.