Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-03 @ 10:19 AM
Study NCT ID:
NCT02283567
Status:
UNKNOWN
Last Update Posted:
2015-09-23
First Post:
2014-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Difference Between Elasticity of the Uterine Cervix in Singleton and Twin Pregnancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2014-10-27', 'studyFirstSubmitQcDate': '2014-11-04', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of elasticity levels in singleton and twin pregnancies (Elastographic measurements of the internal os)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'The investigators aim to compare elasticity of the uterine cervix in singleton and twin pregnancies of similar gestational age.', 'detailedDescription': 'Softening of the uterine cervix occurs during pregnancy.There is a possibility that this process occurs earlier in twin versus singleton pregnancies.The softening of the cervix is reflected by the level of its elasticity which can be measured sonoelastographically. A two dimension image of the cervix is obtained in the midsagittal section and the length is noted. A 2nd sonoelastography image is obtained before pressure is applied with the transducer in the area of the internal os and a third sonoelastography image is obtained until no more shortening of the anterior-posterior diameter is observed.Elastography measurements of the internal os are performed using a color map: red (soft), yellow (medium soft), blue (medium hard) and purple (hard) before and after the application of strain.The change between the color maps before and after strain application in singleton pregnancies will be compared to the change in twin pregnancies of similar gestational age.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '20-44 years old pregnant patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low risk singleton and twin pregnancies\n\nExclusion Criteria:\n\n* Patients with pregnancy complications'}, 'identificationModule': {'nctId': 'NCT02283567', 'acronym': 'DEU', 'briefTitle': 'The Difference Between Elasticity of the Uterine Cervix in Singleton and Twin Pregnancies', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'The Difference Between Elasticity of the Uterine Cervix in Singleton and Twin Pregnancies', 'orgStudyIdInfo': {'id': '0152-14-MMC'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rami Aviram, MD', 'role': 'CONTACT', 'email': 'rami.aviram@clalit.org.il', 'phone': '972544944862'}], 'overallOfficials': [{'name': 'Rami Aviram, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Rami Aviram', 'investigatorAffiliation': 'Meir Medical Center'}}}}