Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT02582268
Status:
UNKNOWN
Last Update Posted:
2015-10-21
First Post:
2015-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel IUD Insertion Technique
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']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-19', 'studyFirstSubmitDate': '2015-10-16', 'studyFirstSubmitQcDate': '2015-10-19', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'degree of pain during IUD insertion', 'timeFrame': '4 months', 'description': 'Pain will be assessed by the use of visual analog scale (VAS).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '28978240', 'type': 'DERIVED', 'citation': 'Dakhly DMR, Bassiouny YA. Ultrasound-guided intrauterine device insertion: a step closer to painless insertion: a randomized control trial. Eur J Contracept Reprod Health Care. 2017 Oct;22(5):349-353. doi: 10.1080/13625187.2017.1381234. Epub 2017 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'A previous trial performed by our research team, in order to reduce the pain associated with intrauterine device insertion, compared the novel technique of IUD insertion under the guidance of the trans-abdominal sonography to the traditional method of IUD insertion. It came up with the conclusion that the TAS guided IUD insertion is significantly lower in pain score and time taken for insertion, when compared with the traditional method. In this study our researchers aim to abolish the distracting effect of the technician and the TAS probe (which might have interfered with previous results).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females desiring contraception with the use of IUD\n* Females with history of previous vaginal delivery\n\nExclusion Criteria:\n\n* Are pregnant or think they may be pregnant\n* Septic pregnancy or abortion\n* Have unexplained abnormal vaginal bleeding\n* Have untreated cervical cancer\n* Have malignant gestational trophoblastic disease\n* Have uterine cancer\n* Have uterine abnormalities\n* Have or may have had a pelvic infection within the past three months\n* Have or may have any sexually transmitted disease\n* Have pelvic tuberculosis\n* Are postpartum between 48 hours and 4 weeks\n* Have benign gestational trophoblastic disease'}, 'identificationModule': {'nctId': 'NCT02582268', 'briefTitle': 'A Novel IUD Insertion Technique', 'organization': {'class': 'OTHER', 'fullName': "Woman's Health University Hospital, Egypt"}, 'officialTitle': 'Introducing Trans- Abdominal Guided Intrauterine Device Insertion, a Single Blinded Randomized Control Trial', 'orgStudyIdInfo': {'id': 'CU151020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAS guided IUD insertion', 'description': 'the female will be asked to be full bladder. the trans-abdominal probe will be placed by an assistant on the suprapubic region. under speculum examination, the intrauterine device IUD (TCu 380A) will be placed till it reaches the fundus of the uterus and then released.', 'interventionNames': ['Device: intrauterine device TCu 380A', 'Radiation: Trans-abdominal sonography']}, {'type': 'EXPERIMENTAL', 'label': 'Traditional IUD insertion', 'description': 'the intrauterine device TCu 380A will be inserted in the conventional method, and checked afterwards by transvaginal ultrasound. the trans-abdominal probe will also be placed by an assistant on the suprapubic region ( the image would be on freeze mode) as it is not actually used , it is just to make the same settings for the participant females.', 'interventionNames': ['Device: intrauterine device TCu 380A']}], 'interventions': [{'name': 'intrauterine device TCu 380A', 'type': 'DEVICE', 'otherNames': ['TCu 380A'], 'armGroupLabels': ['TAS guided IUD insertion', 'Traditional IUD insertion']}, {'name': 'Trans-abdominal sonography', 'type': 'RADIATION', 'otherNames': ['TAS'], 'armGroupLabels': ['TAS guided IUD insertion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12211', 'city': 'Cairo', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Dina M Dakhly, MD', 'role': 'CONTACT', 'email': 'Dinadakhly@gmail.com', 'phone': '01003498919', 'phoneExt': '002'}, {'name': 'Dina M Dakhly, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kasr el aini hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Dina M Dakhly, MD', 'role': 'CONTACT', 'email': 'dinadakhly@gmail.com', 'phone': '01003498919', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Dina M Dakhly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Woman's Health University Hospital, Egypt", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics and Gynecology', 'investigatorFullName': 'Dina Mohamed Refaat Dakhly', 'investigatorAffiliation': "Woman's Health University Hospital, Egypt"}}}}