Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-24 @ 10:30 AM
Study NCT ID:
NCT02679820
Status:
COMPLETED
Last Update Posted:
2019-01-09
First Post:
2016-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PostPlacental IUD 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': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-06', 'studyFirstSubmitDate': '2016-02-08', 'studyFirstSubmitQcDate': '2016-02-08', 'lastUpdatePostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expulsion rate', 'timeFrame': '6 months'}, {'measure': 'The percentage of females seeking contraception', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '33006501', 'type': 'DERIVED', 'citation': 'Bayoumi YA, Dakhly DMR, Bassiouny YA, Gouda HM, Hassan MA, Hassan AA. Post-placental intrauterine device insertion vs puerperal insertion in women undergoing caesarean delivery in Egypt: a 1 year randomised controlled trial. Eur J Contracept Reprod Health Care. 2020 Dec;25(6):439-444. doi: 10.1080/13625187.2020.1823366. Epub 2020 Oct 2.'}]}, 'descriptionModule': {'briefSummary': 'The immediate post cesarean section IUD insertion is a further step towards spreading more compliance to females in developing countries, with rapid increase in population size'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females desiring contraception by using intrauterine device following their vaginal delivery or cesarean section\n\nExclusion Criteria:\n\n* refusal to participate in the study\n* desiring other methods of contraception\n* will not use any method of contraception\n* has a contraindication for the use of IUD as bicornuate or septate uterus, sub mucous myomas, etc.'}, 'identificationModule': {'nctId': 'NCT02679820', 'briefTitle': 'PostPlacental IUD Insertion', 'organization': {'class': 'OTHER', 'fullName': "Woman's Health University Hospital, Egypt"}, 'orgStudyIdInfo': {'id': 'LA010516'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PostPlacental IUD insertion', 'description': 'Copper T intrauterine device will be inserted immediately following delivery of the placenta in cases of cesarean section deliveries.', 'interventionNames': ['Device: Copper T intrauterine device']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'IUD will be offered as a method of contraception after puerperium'}], 'interventions': [{'name': 'Copper T intrauterine device', 'type': 'DEVICE', 'otherNames': ['copper T IUD'], 'armGroupLabels': ['PostPlacental IUD insertion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12211', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr el aini hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Dina MR Dakhly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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"}}}}