Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT02054195
Status:
COMPLETED
Last Update Posted:
2014-02-04
First Post:
2014-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Training Model on Insertion Techniques for Postplacental Intra Uterine Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-01', 'studyFirstSubmitDate': '2014-01-25', 'studyFirstSubmitQcDate': '2014-02-01', 'lastUpdatePostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with IUD total or partial expulsion', 'timeFrame': '12 Months', 'description': 'Transabdominal ultrasonography examination was done by researcher right after insertion. Ultrasonography examination was done using longitudinal and transversal scan, with client in supine position using real time convex 2 probe with 3,5 Mhz frequency. While transvaginal ultrasonography examination was done when the client come after 6 weeks, 6 months and 12 months after insertion.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants with retained skill and knowledge', 'timeFrame': '12 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Intra-uterine Device Complication']}, 'descriptionModule': {'briefSummary': 'This study aimed to compare special guided training model with standard procedure on insertion technique for post-placental intra uterine device that provides IUD location close enough to fundal part of uterus to prevent expulsion', 'detailedDescription': 'The standard of insertion IUD postplacental can not provide prevention of expulsion. Special techniques on insertion IUD is needed for preventing expulsion. This training model is consisted of the special techniques to provide intra uterine device post placental close enough to fundal part of uterus to prevent expulsion'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 37-42 weeks gestation pregnancy women in delivery, singleton pregnancy, without any uterine anomaly\n\nExclusion Criteria:\n\n* Any bleeding and infection complication'}, 'identificationModule': {'nctId': 'NCT02054195', 'acronym': 'PTKP', 'briefTitle': 'Training Model on Insertion Techniques for Postplacental Intra Uterine Device', 'organization': {'class': 'OTHER', 'fullName': 'Showa University'}, 'officialTitle': 'Study of Special Guided Training Model on Insertion Techniques for Postplacental Intra Uterine Device to Prevent Expulsion', 'orgStudyIdInfo': {'id': 'jm1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IUD new technique', 'description': 'Training', 'interventionNames': ['Behavioral: Training']}, {'type': 'EXPERIMENTAL', 'label': 'No Training', 'description': 'No Training', 'interventionNames': ['Behavioral: No Training']}], 'interventions': [{'name': 'Training', 'type': 'BEHAVIORAL', 'description': 'Training model is consist of effort to provide intra uterine device post placental by organising a special guided training model for post-placental IUD insertion by pushing the head of IUD using index and middle finger close enough to fundal part of uterus to prevent expulsion.', 'armGroupLabels': ['IUD new technique']}, {'name': 'No Training', 'type': 'BEHAVIORAL', 'description': 'Control of Training model is without training on effort of pushing the head of IUD using index and middle finger to uterine fundus.', 'armGroupLabels': ['No Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'state': 'Jakarta Special Capital Region', 'country': 'Indonesia', 'facility': 'Central nationalHospital Cipto Mangunkusumo', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Seno Adjie, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Showa University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Yuditiya Purwosunu', 'investigatorAffiliation': 'Showa University'}}}}