Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-25 @ 8:45 PM
Study NCT ID:
NCT01539759
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2012-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Erika.Levi@gmail.com', 'phone': '(919) 843-5633', 'title': 'Erika Levi, MD and Gretchen Stuart, MD', 'organization': 'University of North Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Interval IUD Placement', 'description': 'Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery', 'otherNumAtRisk': 56, 'otherNumAffected': 1, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Immediate Postplacental IUD Placement', 'description': 'Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta\n\nImmediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta', 'otherNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Uterine Perforation', 'notes': 'Uterine Perforation with IUD placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'IUD Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interval IUD Placement', 'description': 'Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery'}, {'id': 'OG001', 'title': 'Immediate Postplacental IUD Placement', 'description': 'Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta\n\nImmediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months postpartum', 'description': 'The use of an IUD at 6 months postpartum is the primary outcome measure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'IUD Expulsion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interval IUD Placement', 'description': 'Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery'}, {'id': 'OG001', 'title': 'Immediate Postplacental IUD Placement', 'description': 'Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta\n\nImmediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-6 months postpartum', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Women's Satisfaction With IUDs", 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interval IUD Placement', 'description': 'Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery'}, {'id': 'OG001', 'title': 'Immediate Postplacental IUD Placement', 'description': 'Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta\n\nImmediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-6 months postpartum', 'unitOfMeasure': 'percentage of participants satisfied', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interval IUD Placement', 'description': 'Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery'}, {'id': 'FG001', 'title': 'Immediate Postplacental IUD Placement', 'description': 'Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta\n\nImmediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'Had Successful IUD Placement', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'IUD Expulsion', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'IUD Removal', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'IUD in Place at 6 Months Posptartum', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Interval IUD Placement', 'description': 'Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery'}, {'id': 'BG001', 'title': 'Immediate Postplacental IUD Placement', 'description': 'Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta\n\nImmediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29', 'spread': '.51', 'groupId': 'BG000'}, {'value': '28', 'spread': '.57', 'groupId': 'BG001'}, {'value': '28', 'spread': '.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-12', 'studyFirstSubmitDate': '2012-02-21', 'resultsFirstSubmitDate': '2015-06-16', 'studyFirstSubmitQcDate': '2012-02-21', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-06-16', 'studyFirstPostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IUD Use', 'timeFrame': '6 months postpartum', 'description': 'The use of an IUD at 6 months postpartum is the primary outcome measure'}], 'secondaryOutcomes': [{'measure': 'IUD Expulsion', 'timeFrame': '0-6 months postpartum'}, {'measure': "Women's Satisfaction With IUDs", 'timeFrame': '0-6 months postpartum'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postpartum Contraception', 'Intrauterine Devices'], 'conditions': ['Intrauterine Devices', 'Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '26241250', 'type': 'DERIVED', 'citation': 'Levi EE, Stuart GS, Zerden ML, Garrett JM, Bryant AG. Intrauterine Device Placement During Cesarean Delivery and Continued Use 6 Months Postpartum: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):5-11. doi: 10.1097/AOG.0000000000000882.'}]}, 'descriptionModule': {'briefSummary': "This is a randomized controlled trial among women who deliver by cesarean at UNC Women's Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of the Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the 4-8 week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months later than women who plan on receiving an IUD 4-8 weeks after delivery."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women ages 18-45\n* Pregnant and greater than or equal to 24 weeks of estimated gestational age\n* Live Pregnancy\n* States a plan to use an Intrauterine Device (IUD) postpartum for contraception\n* Plan for cesarean delivery\n* Intend to stay in the Chapel Hill area for at least 6 months after birth\n* Fluent in English or Spanish\n\nExclusion Criteria:\n\n* known uterine anomalies\n* allergies to any component of the IUD of their choosing\n* known or suspected carcinoma of the breast\n* known acute liver disease or liver tumor (benign or malignant)\n* known or suspected uterine or cervical neoplasia\n* active pelvic inflammatory disease\n* genital bleeding of unknown etiology\n* history of solid organ transplantation\n* positive test for gonorrhea or chlamydia during this pregnancy'}, 'identificationModule': {'nctId': 'NCT01539759', 'acronym': 'IUD@CSD', 'briefTitle': 'Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Immediate Postplacental Insertion of Intrauterine Devices at Time of Cesarean Delivery: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '11-2477'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Interval IUD Placement', 'description': 'Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery'}, {'type': 'EXPERIMENTAL', 'label': 'Immediate Postplacental IUD placement', 'description': 'Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta', 'interventionNames': ['Device: Immediate Postplacental Placement of an IUD during cesarean delivery']}], 'interventions': [{'name': 'Immediate Postplacental Placement of an IUD during cesarean delivery', 'type': 'DEVICE', 'description': 'Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta', 'armGroupLabels': ['Immediate Postplacental IUD placement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina, Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Erika Levi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Erika Levi, MD, MPH', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}