Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-04-24 @ 2:54 AM
Study NCT ID:
NCT02037334
Status:
COMPLETED
Last Update Posted:
2022-12-09
First Post:
2014-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomechanics Based Prediction of Preterm Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1002}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-08', 'studyFirstSubmitDate': '2014-01-13', 'studyFirstSubmitQcDate': '2014-01-14', 'lastUpdatePostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in cervical stiffness in women with/without preterm delivery', 'timeFrame': 'Measurements between 18+0/7 and 22+0/7 weeks of pregnancy and postpartum', 'description': 'The biomechanical measurements and morphological data obtained at mid-pregnancy are compared between women with/without preterm delivery and are expected to significantly differ. The diagnostic power for preterm delivery of aspiration, CCI and the other factors will be determined.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preterm delivery', 'Diagnostics', 'Biomechanics'], 'conditions': ['Preterm Delivery']}, 'descriptionModule': {'briefSummary': 'Quantitative information on the biomechanical properties of the ecto-cervix in mid-pregnancy will be compared between women with term vs. preterm delivery. We aim to demonstrate that biomechanical data (ASP and CCI) might complement morphological data (CL) to improve prediction of preterm delivery. It is expected that women with preterm delivery will show stronger weakening of cervical tissue. Aspiration (ASP) and cervical CCI (cervical consistency index) measurements are performed at mid-pregnancy: detection at this time point is useful for therapy and biomechanical modifications are already significant so to enable differentiation by biomechanical measurements (ASP and CCI).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All pregnant women at our institutions between 18+0/7 and 22+0/7 weeks of pregnancy and postpartum', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All pregnant women presenting at their mid pregnancy consultation (18+0 - 22+0 weeks of pregnancy) are eligible\n* Signed informed consent after being informed is a prerequisite for enrollment.\n\nExclusion Criteria:\n\n* Communication problems\n* Missing consent\n* Age\\<18\n* Active bleeding / Premature Rupture of Membranes (PROM)\n* Active genital infection\n* Known carrier of HIV or Hepatitis B or C\n* Placenta praevia\n* Müllerian anomalies\n* known or suspected non-compliance, drug or alcohol abuse\n* cerclage\n* use of pessary'}, 'identificationModule': {'nctId': 'NCT02037334', 'acronym': 'Softcervix', 'briefTitle': 'Biomechanics Based Prediction of Preterm Delivery', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Biomechanics Based Prediction of Preterm Delivery', 'orgStudyIdInfo': {'id': 'KEK-ZH 2013-0244'}, 'secondaryIdInfos': [{'id': '2013-MD-0036', 'type': 'OTHER', 'domain': 'Swissmedic'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnancy', 'interventionNames': ['Device: Pregnolia System']}], 'interventions': [{'name': 'Pregnolia System', 'type': 'DEVICE', 'description': 'No intervention is done except for measuring the stiffness of the cervix in pregnant women', 'armGroupLabels': ['Pregnancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital of Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Aarau', 'country': 'Switzerland', 'facility': 'Kantonsspital Aarau, Frauenklinik', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'city': 'Baden', 'country': 'Switzerland', 'facility': 'Kantonsspital Baden, Frauenklinik', 'geoPoint': {'lat': 47.47333, 'lon': 8.30592}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'Universitätsspital Basel, Frauenklinik', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Frauenfeld', 'country': 'Switzerland', 'facility': 'Kantonsspital Frauenfeld, Frauenklinik', 'geoPoint': {'lat': 47.55776, 'lon': 8.89893}}, {'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hôpitaux universitaires de Genève (HUG)', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Kantonsspital Luzern, Frauenklinik', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}, {'city': 'Münsterlingen', 'country': 'Switzerland', 'facility': 'Kantonsspital Münsterlingen', 'geoPoint': {'lat': 47.63197, 'lon': 9.23271}}, {'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Kantonsspital St. Gallen, Klinik für Gynäkologie und Geburtshilfe', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'city': 'Winterthur', 'country': 'Switzerland', 'facility': 'Kantonsspital Winterthur', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}, {'city': 'Zollikon', 'country': 'Switzerland', 'facility': 'Praxis Zollikon', 'geoPoint': {'lat': 47.34019, 'lon': 8.57407}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital of Zurich, Dept. OB/Gyn', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Stadtspital Triemli, Frauenklinik', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'David A Scheiner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Scheiner', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, {'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'David Scheiner', 'investigatorAffiliation': 'University of Zurich'}}}}