Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-01-04 @ 11:46 AM
Study NCT ID:
NCT04151303
Status:
UNKNOWN
Last Update Posted:
2019-11-05
First Post:
2019-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Optimal Timing for Cerclage Removal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D023802', 'term': 'Cerclage, Cervical'}], 'ancestors': [{'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-02', 'studyFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2019-11-02', 'lastUpdatePostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cercalge removal and neonatal morbidity', 'timeFrame': '1 year', 'description': 'Neonatal respiratory morbidity after cerclage removal'}], 'secondaryOutcomes': [{'measure': 'The optimal timing for cerclage removal', 'timeFrame': '1 year', 'description': 'Time interval between cerclage removal and gestational age of delivery.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RDS', 'CERCLAGE', 'CERVIX INSUFFICIENCY'], 'conditions': ['Respiratory Disease of A Newborn']}, 'descriptionModule': {'briefSummary': 'Women with a history of cervical insufficiency can be managed with elective cervical cerclage placed at the beginning of the second trimester. The McDonald technique is the most commonly used. Though lack a robust scientific evidence, the cerclage is removed electively at 36-37 weeks of gestation in order to avoid maternal cervical laceration. In addition, the incidence of spontaneous delivery is nearly 20% within 72 hours after ceclage removal, thus elective cerclage removal at 36-37 weeks may also put the newborns at complications associated with iatrogenic late preterm/early term delivery', 'detailedDescription': 'The optimal timing of cervical cerclage removal is yet unclear.\n\nIn the present study we will evaluate maternal and neonatal outcome variables after elective removal of the cerclage, and may suggest a gestational week cut-off for optimal cerclage removal/\n\nPrimary outcome:\n\nNeonatal respiratory morbidity after cerclage removal. The respiratory outcome will be compared across each gestational week of delivery after cerclage removal, that is; group 1 (36-36.6 weeks), group 2 (37-37.6 weeks), group 3 (38-38.6 weeks), group 4 (beyond 39 weeks).\n\nSecondary outcomes:\n\nTime interval between cerclage removal and gestational age of delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- Women with singleton pregnancies with elective or emergent cerclage that was electively removed after 36 weeks of pregnancy.', 'genderDescription': 'Pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancies\n* Elective or emergent cerclage in the current pregnancy\n* Cerclage that was removed after 36 weeks of pregnancy\n\nExclusion Criteria:\n\n* Multiple pregnancies\n* Major congenital anomalies\n* Cerclage removal before 36weeks of pregnancy'}, 'identificationModule': {'nctId': 'NCT04151303', 'briefTitle': 'The Optimal Timing for Cerclage Removal', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'The Optimal Timing for Cerclage Removal', 'orgStudyIdInfo': {'id': '0410-19-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cerclage 1', 'description': "Time to delivery after cerclage removal Between 36-36.6 weeks' gestation - group 1", 'interventionNames': ['Procedure: Cervical cerclage']}, {'label': 'Cerclage 2', 'description': "Time to delivery after cerclage removal Between 37-37.6 weeks' gestation - group 2", 'interventionNames': ['Procedure: Cervical cerclage']}, {'label': 'Cerclage 3', 'description': "Between 38-38.6 weeks' gestation - group 3", 'interventionNames': ['Procedure: Cervical cerclage']}, {'label': 'Cerclage 4', 'description': "Time to delivery after cerclage removal Beyond 39 weeks' gestation - group 4", 'interventionNames': ['Procedure: Cervical cerclage']}], 'interventions': [{'name': 'Cervical cerclage', 'type': 'PROCEDURE', 'description': 'Cervical cerclage and cervical cerclage removal', 'armGroupLabels': ['Cerclage 1', 'Cerclage 2', 'Cerclage 3', 'Cerclage 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam health care campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Yaniv Zipori, M.D', 'role': 'CONTACT', 'email': 'y_zipori@rambam.health.gov.il', 'phone': '+972 58 7966963'}], 'overallOfficials': [{'name': 'Yaniv Zipori, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Yet undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yaniv Zipori MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}