Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2026-02-21 @ 4:08 PM
Study NCT ID:
NCT02393495
Status:
COMPLETED
Last Update Posted:
2015-09-01
First Post:
2015-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Intra-uterine Device Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-30', 'studyFirstSubmitDate': '2015-01-23', 'studyFirstSubmitQcDate': '2015-03-18', 'lastUpdatePostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of degree of pain during IUD insertion', 'timeFrame': '6 months', 'description': 'Pain will be assessed by the use of visual analog scale, Pain rating scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': 'Different studies have been made in an attempt to reduce the pain and the duration of the process of outpatient insertion of the intrauterine device. in this trial, the investigators aim to insert the IUD under ultrasonographic guidance, which can help to reduce the pain, decrease the process of insertion, in addition, it reduces the incidence of malposition of IUD as well as the risk of complications.'}, '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\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\n* Have ovarian cancer\n* Have AIDS (unless clinically well on anti-retroviral therapy)'}, 'identificationModule': {'nctId': 'NCT02393495', 'briefTitle': 'Ultrasound Guided Intra-uterine Device Insertion', 'organization': {'class': 'OTHER', 'fullName': "Woman's Health University Hospital, Egypt"}, 'officialTitle': 'A Further Step Towards Painless Intrauterine Device Insertion, a Randomized Control Trial', 'orgStudyIdInfo': {'id': '22012015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound guided group', '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']}, {'type': 'EXPERIMENTAL', 'label': 'Non ultrasound guided group', 'description': 'the intrauterine device TCu 380A will be inserted in the conventional method, and checked afterwards by transvaginal ultrasound.', 'interventionNames': ['Device: intrauterine device TCu 380A']}], 'interventions': [{'name': 'intrauterine device TCu 380A', 'type': 'DEVICE', 'otherNames': ['TCu 380A'], 'armGroupLabels': ['Non ultrasound guided group', 'Ultrasound guided group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12211', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr el ainy hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Dina MR 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"}}}}