Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-12 @ 11:45 PM
Study NCT ID:
NCT02901561
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2016-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between 2 Doses of Misoprostol Before Intrauterine Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-12', 'studyFirstSubmitDate': '2016-09-10', 'studyFirstSubmitQcDate': '2016-09-10', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean pain score during intrauterine device insertion', 'timeFrame': '5 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain Relief']}, 'descriptionModule': {'briefSummary': "The purpose of the investigators' study was to evaluate whether misoprostol will improve pain scores .", 'detailedDescription': 'an intrauterine device 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 intrauterine device insertion tube, and removing the tube; and placement of the device in the uterus.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Women not taken analgesics or anxiolytics in the 24 hours prior insertion\n\n * Women who will accept to participate in the study\n\nExclusion Criteria:\n\n* Any contraindication to IUD placement'}, 'identificationModule': {'nctId': 'NCT02901561', 'briefTitle': 'Comparison Between 2 Doses of Misoprostol Before Intrauterine Device', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparison Between 2 Different Doses of Vaginal Misoprostol Before Intrauterine Device Insertion in Parous Women', 'orgStudyIdInfo': {'id': 'MISO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'misoprostol 200', 'description': 'misoprostol 200 microgram placed into the vagina 3 hours prior to having the intrauterine device inserted', 'interventionNames': ['Drug: misoprostol 200']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'misoprostol 400', 'description': 'misoprostol 400 microgram placed into the vagina 3 hours prior to having the intrauterine device inserted', 'interventionNames': ['Drug: misoprostol 400']}], 'interventions': [{'name': 'misoprostol 200', 'type': 'DRUG', 'armGroupLabels': ['misoprostol 200']}, {'name': 'misoprostol 400', 'type': 'DRUG', 'armGroupLabels': ['misoprostol 400']}]}, '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'}}}}