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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2023-07-31', 'studyFirstSubmitQcDate': '2023-07-31', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Vaginal Delivery', 'timeFrame': '5 days (time of commencing induction of labour to outcome of delivery)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical stiffness', 'induction of labour'], 'conditions': ['Induced Vaginal Delivery']}, 'referencesModule': {'references': [{'pmid': '39820788', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://en.pregnolia.com/', 'label': 'Cervical stiffness assessment device website Available IPD/Information:'}]}, 'descriptionModule': {'briefSummary': "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.\n\nA 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.", 'detailedDescription': "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).\n\nAll 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.\n\nOnce 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with singleton, term pregnancy, requiring induction of labour.', 'genderDescription': 'Female of reproductive age with confirmed singleton pregnancy.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Being induced\n* Singleton pregnancy\n* Primiparous\n* ≥37+0 weeks gestation\n* Intact membranes\n* Able to provide informed consent\n\nExclusion criteria:\n\n* Previous cervical surgery\n* Any cervical pathology at 12 o'clock position on cervix\n* Vaginal bleeding evident on examination\n* Visible, symptomatic cervical or vaginal infections\n* Known congenital uterine anomalies\n* Known or suspected structural/chromosomal fetal abnormality\n* Known HIV\n* Cervical carcinoma"}, 'identificationModule': {'nctId': 'NCT05981469', 'acronym': 'CASPAR', 'briefTitle': 'Can Cervical Stiffness Predict Successful Vaginal Delivery After Induction of Labour?', 'organization': {'class': 'OTHER', 'fullName': 'University of Liverpool'}, 'officialTitle': 'Can Cervical Stiffness Predict Successful Vaginal Delivery After Induction of Labour?', 'orgStudyIdInfo': {'id': 'UoL001713'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Induction of labour', 'interventionNames': ['Device: Cervical Stiffness Assessmenr', "Other: Bishop's Score Assessment"]}], 'interventions': [{'name': 'Cervical Stiffness Assessmenr', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['Induction of labour']}, {'name': "Bishop's Score Assessment", 'type': 'OTHER', 'description': "Sterile digital vaginal examination to illicit the Bishop's score (0-12).", 'armGroupLabels': ['Induction of labour']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Liverpool', 'country': 'United Kingdom', 'facility': "Liverpool Women's Hospital", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'Andrew Sharp', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Liverpool'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liverpool', 'class': 'OTHER'}, 'collaborators': [{'name': "Liverpool Women's NHS Foundation Trust", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}