Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-02-22 @ 3:55 PM
Study NCT ID:
NCT02905058
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2016-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Ketoprofen Before Intrauterine Device Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007660', 'term': 'Ketoprofen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-11', 'studyFirstSubmitDate': '2016-09-14', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean pain score during IUD insertion', 'timeFrame': '5 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain Relief']}, 'descriptionModule': {'briefSummary': 'IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the device in the uterus.', 'detailedDescription': 'To minimize the discomfort and the hazards of an IUD insertion, several measures have been proposed including NSAIDs, anxiolytics, and local anesthetics in the form of intracervical gel, cervical and para-cervical block, but there have not done enough studies about their effectiveness. According to the review published in the Cochrane, non-steroidal anti-inflammatory drugs and misoprostol are not effective on reducing an IUD insertion pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women not taken analgesics or anxiolytics in the 24 hours prior insertion\n* Women not taken misoprostol prior to insertion\n* No contraindication to Non-steroidal drugs\n* Women who will accept to participate in the study\n\nExclusion Criteria:\n\n* Any contraindication to device placement'}, 'identificationModule': {'nctId': 'NCT02905058', 'briefTitle': 'Efficacy of Ketoprofen Before Intrauterine Device Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Oral Ketoprofen on Intra Uterine Device Insertion Pain: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KETOIUD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketoprofen', 'description': 'women will take one tablet 150 mg one hour before the procedure', 'interventionNames': ['Drug: Ketoprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'women will take one placebo tablet one hour before the procedure', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Ketoprofen', 'type': 'DRUG', 'otherNames': ['bi profenid'], 'description': 'oral non-steroidal antiinflammatory drug', 'armGroupLabels': ['Ketoprofen']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Assiut', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ahmed Abbas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ahmed Mohamed Abbas', 'investigatorAffiliation': 'Assiut University'}}}}