Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-01-01 @ 5:26 PM
Study NCT ID:
NCT00790504
Status:
WITHDRAWN
Last Update Posted:
2017-05-02
First Post:
2008-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transperineal Ultrasound for the Female Pelvic Floor in Women With Multiple Gestation
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': 0}}, 'statusModule': {'whyStopped': 'Difficulty recruiting patient. Lack of research assistant.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-29', 'studyFirstSubmitDate': '2008-11-11', 'studyFirstSubmitQcDate': '2008-11-12', 'lastUpdatePostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Multiple gestation affects the pelvic floor more than singleton gestation', 'timeFrame': 'Until recruitment completion'}], 'secondaryOutcomes': [{'measure': 'The mode of delivery affects pelvic floor outcome', 'timeFrame': 'As above'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pelvic floor', 'Transperineal ultrasound', 'Multiple pregnancy', 'Singleton pregnancy', 'Female pelvic floor'], 'conditions': ['Multiple Pregnancy']}, 'descriptionModule': {'briefSummary': 'This trial studies the effect of pregnancies of multiple gestations (i.e. twins, triplets etc.) on the female pelvic floor with regards to the pregnancy itself and labor and delivery mode, by using transperineal ultrasound. This will be compared with pregnancies with single fetuses.', 'detailedDescription': 'This trial studies the effect of pregnancies of multiple gestations (i.e. twins, triplets etc.) on the female pelvic floor with regards to the pregnancy itself and labor and delivery mode, by using transperineal ultrasound. This will be compared with pregnancies with single fetuses. See study protocol.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with multiple gestations recruited from the prenatal care or high risk pregnancy units', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with multiple gestations\n* Women with singleton gestation\n* Able to understand the consent form\n\nExclusion Criteria:\n\n* None specified'}, 'identificationModule': {'nctId': 'NCT00790504', 'briefTitle': 'Transperineal Ultrasound for the Female Pelvic Floor in Women With Multiple Gestation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Prospective Follow up of the Female Pelvic Floor in Multiple Gestation Using Transperineal Ultrasound', 'orgStudyIdInfo': {'id': 'SHEBA-08-5470-VE-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1 study group', 'description': 'Women with multiple gestations recruited from the prenatal care or high risk pregnancy units'}, {'label': '2 control group', 'description': 'Women with singleton gestation recruited from the prenatal care or high risk pregnancy units'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'overallOfficials': [{'name': 'Vered H Eisenberg, MD MHA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dr. Vered Eisenberg', 'investigatorAffiliation': 'Sheba Medical Center'}}}}