Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-03-01 @ 3:22 AM
Study NCT ID:
NCT03034434
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2017-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cervical Recuperation After Vaginal Delivery
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': 1384}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-24', 'studyFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2017-01-26', 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cervical length after vaginal delivery.', 'timeFrame': 'Up to 48 hours post delivery.', 'description': 'Measurement of cervical length 8, 24, 48 hours after vaginal delivery by trans-vaginal ultrasound.'}], 'secondaryOutcomes': [{'measure': 'Differences in cervical length after vaginal delivery.', 'timeFrame': 'Up to 48 hours post delivery.', 'description': 'Differences in cervical length after vaginal delivery as a factor of gestational age at delivery, means of labor induction, parity, etc.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervix']}, 'referencesModule': {'references': [{'pmid': '36265677', 'type': 'DERIVED', 'citation': 'Lauterbach R, Bachar G, Ben-David C, Justman N, Siegler Y, Tzur L, Copel JA, Weiner Z, Beloosesky R, Ginsberg Y. Postpartum cervical length as a predictor of subsequent preterm birth-novel insights on an old enigma. Am J Obstet Gynecol. 2023 Apr;228(4):461.e1-461.e8. doi: 10.1016/j.ajog.2022.10.012. Epub 2022 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'Patients after vaginal delivery will undergo 3 trans-vaginal ultrasounds in order to examine the process of cervical recuperation post delivery.', 'detailedDescription': "Patients after vaginal delivery will be recruited after receiving a full explanation and signing an informed consent.\n\nThe goal of the study is to examine cervical length after vaginal delivery at 3 different time intervals:\n\n1. 8 hours post delivery.\n2. 24 hours post delivery.\n3. 48 hours post delivery. At each interval a trans-vaginal ultrasound will be performed, evaluating cervical length. At the end of the 3rd and final ultrasound, the patient will finish her participation in the study/ Information regarding obstetric conditions such as labor induction, gestational age at the time of delivery etc. will be collected from patients' electronic files."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients after vaginal delivery.', 'genderDescription': 'Female patients only.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient after vaginal delivery.\n\nExclusion Criteria:\n\n* Any patient after cesarean section.'}, 'identificationModule': {'nctId': 'NCT03034434', 'briefTitle': 'Cervical Recuperation After Vaginal Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Sonography Evaluation of Cervical Recuperation After Vaginal Delivery', 'orgStudyIdInfo': {'id': '0154-16-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients after vaginal delivery', 'description': 'Patients after vaginal delivery willing to undergo 3 trans-vaginal ultrasounds within the 48 hours after delivery.', 'interventionNames': ['Device: Trans-vaginal ultrasound']}], 'interventions': [{'name': 'Trans-vaginal ultrasound', 'type': 'DEVICE', 'description': 'Three trans-vaginal ultrasounds, the 1st to be performed 8 hours post delivery, the 2nd 24 hours after delivery and the 3rd 48 hours after delivery.', 'armGroupLabels': ['Patients after vaginal delivery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam health care campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Roy Lauterbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'ROY LAUTERBACH MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}