Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2026-03-04 @ 11:48 AM
Study NCT ID:
NCT03106805
Status:
WITHDRAWN
Last Update Posted:
2022-05-11
First Post:
2017-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Versus Late Interval Postpartum Copper Intrauterine Device Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003268', 'term': 'Contraception Behavior'}], 'ancestors': [{'id': 'D043762', 'term': 'Reproductive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no participants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-06', 'studyFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2017-04-04', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of participants use the device', 'timeFrame': '6 weeks', 'description': 'number of women place the intrauterine device within 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intrauterine device'], 'conditions': ['Contraception Behavior']}, 'referencesModule': {'references': [{'pmid': '27405702', 'type': 'BACKGROUND', 'citation': 'Shachar BZ, Mayo JA, Lyell DJ, Baer RJ, Jeliffe-Pawlowski LL, Stevenson DK, Shaw GM. Interpregnancy interval after live birth or pregnancy termination and estimated risk of preterm birth: a retrospective cohort study. BJOG. 2016 Nov;123(12):2009-2017. doi: 10.1111/1471-0528.14165. Epub 2016 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'The optimal interval between pregnancies is debated, but a duration greater than 11-18 months has been suggested as reducing complications in the subsequent pregnancy. Improved birth spacing can be a key benefit use of long-acting reversible contraception, but delay to initiation can still be problematic.So women who have recently given birth can be cost-effectively targeted for family planning education and engagement because often they are already connected with health professionals'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDelivered (vaginal or Cesarean) a singleton living baby ≥28weeks gestation. Women desire birth spacing for one year or more. Women who will accept to participate in the study and follow up.\n\nExclusion Criteria:\n\n1. Known uterine anomalies.\n2. Women with previous ectopic pregnancy.\n3. Presence of postpartum pyrexia.\n4. Women with history of postpartum hemorrhage in the last delivery either primary or secondary.\n5. Retained products of conception.\n6. History of previous uterine perforation.\n7. Anticipation of difficulty of subsequent follow-up with the women.\n8. Women with uncontrolled diabetes and hypertension.\n9. Women who wish to use other contraceptive methods.'}, 'identificationModule': {'nctId': 'NCT03106805', 'briefTitle': 'Early Versus Late Interval Postpartum Copper Intrauterine Device Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Early (4th Week) Versus Late (6thweek) Interval Postpartum Copper Intrauterine Device Insertion: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'EAIUD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'insertion by the end of the 4th week postpartum', 'interventionNames': ['Procedure: early insertion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'insertion by the end of the 6th week postpartum', 'interventionNames': ['Procedure: late insertion']}], 'interventions': [{'name': 'early insertion', 'type': 'PROCEDURE', 'description': 'insertion at 4th postpartum week', 'armGroupLabels': ['insertion by the end of the 4th week postpartum']}, {'name': 'late insertion', 'type': 'PROCEDURE', 'description': 'insertion at 6th postpartum week', 'armGroupLabels': ['insertion by the end of the 6th week postpartum']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut Faculty of Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Ahmed Abbas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Ahmed Mohamed Abbas', 'investigatorAffiliation': 'Assiut University'}}}}