Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-25 @ 5:23 PM
Study NCT ID:
NCT03532503
Status:
UNKNOWN
Last Update Posted:
2019-08-20
First Post:
2018-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Second Trimester Pregnancy Termination With Foley Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-16', 'studyFirstSubmitDate': '2018-05-09', 'studyFirstSubmitQcDate': '2018-05-09', 'lastUpdatePostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'induction abortus interval', 'timeFrame': 'up to five days', 'description': 'time to abortus will be recorded'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy termination', 'second trimester', 'foley catheter'], 'conditions': ['Pregnancy Termination']}, 'descriptionModule': {'briefSummary': 'One of the methods used to induce second trimester pregnancy termination is the placement of a transcervical Foley catheter. The aim of this randomized controlled study was to assess in pregnant women with an unfavourable cervix, whether there is a difference in efficacy between the two most commonly used insufflation volumes of Foley catheter (30mL and 50mL).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* singleton pregnancies\n* second trimester pregnancy ermination\n\nExclusion Criteria:\n\n* multiple pregnancies'}, 'identificationModule': {'nctId': 'NCT03532503', 'briefTitle': 'Second Trimester Pregnancy Termination With Foley Catheter', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Second Trimester Pregnancy Termination With Foley Catheter With 30 ml vs 50 ml: Prospective Randomised Study', 'orgStudyIdInfo': {'id': '2018.4.18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Foley catheter filled with 30 ml', 'description': 'The transcervical placement of the foley catheter will be performed and it will be filled with 30 ml saline. A gentle traction will be applied.', 'interventionNames': ['Device: Foley catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Foley catheter filled with 50 ml', 'description': 'The transcervical placement of the foley catheter will be performed and it will be filled with 50 ml saline. A gentle traction will be applied.', 'interventionNames': ['Device: Foley catheter']}], 'interventions': [{'name': 'Foley catheter', 'type': 'DEVICE', 'description': 'Transcervical foley catheter will be applied', 'armGroupLabels': ['Foley catheter filled with 30 ml', 'Foley catheter filled with 50 ml']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Berna Aslan Çetin', 'role': 'CONTACT'}], 'facility': 'Kanuni SSTRH', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Berna Aslan Cetin', 'role': 'CONTACT', 'email': 'bernaaslan14@hotmail.com', 'phone': '902124141500'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Md, ObGYN', 'investigatorFullName': 'Berna Aslan Cetin', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}