Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-03 @ 4:31 AM
Study NCT ID:
NCT01439802
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2011-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elevi@montefiore.org', 'phone': '718-405-8260', 'title': 'Dr. Erika Levi', 'organization': 'Albert Einstein College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months postpartum', 'eventGroups': [{'id': 'EG000', 'title': 'Postplacental Insertion of Intrauterine Device (IUD)', 'description': 'This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group.\n\nIUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 23, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Heavy menstrual bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Expulsion of IUD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Postplacental Insertion of Intrauterine Device (IUD)', 'description': 'This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group.\n\nIUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion.'}], 'classes': [{'title': 'IUD Maintained', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'IUD Expelled', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 week postpartum', 'description': 'Number of participants with Expulsion of IUDs placed at time of cesarean delivery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Fifty-four (54) of ninety (90) participants were able to be reached for a response at 6 weeks either in person or via telephone.'}, {'type': 'SECONDARY', 'title': 'Satisfaction of IUD Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Postplacental Insertion of Intrauterine Device (IUD)', 'description': 'This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group.\n\nIUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion.'}], 'classes': [{'title': 'Very Happy/Happy', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Somewhat Happy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Unsure', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Unhappy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months postpartum', 'description': 'Satisfaction of subjects who received an IUD at time of cesarean delivery was measured based on a telephone survey administered 6 months postpartum. A 4-point Likert scale ("Very Happy/Happy", "Somewhat Happy", "Unsure", "Unhappy") was used to evaluate participants\' attitude toward the IUD.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Forty-two (42) of the ninety (90) enrolled participants were able to be reached at 6 months following IUD placement.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Expulsion of IUD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Postplacental Insertion of Intrauterine Device (IUD)', 'description': 'This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group.\n\nIUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion.'}], 'classes': [{'title': 'IUD Maintained', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'IUD Expelled', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months postpartum', 'description': 'Number of participants with Expulsion of IUDs placed at time of cesarean delivery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Forty-two (42) of ninety (90) participants were able to reached at 6 months following IUD placement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Postplacental Insertion of Intrauterine Device (IUD)', 'description': 'This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group.\n\nIUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion.'}], 'periods': [{'title': '6 Weeks Postpartum Status', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}]}]}, {'title': '6 Months Postpartum Status', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'Recruitment took place in two Bronx medical centers. During prenatal care, all women were counseled regarding contraception. Women who intended to use the copper T380A IUD postpartum were approached and informed about the study after arriving on labor and delivery. Women undergoing cesarean delivery at \\>= 35 weeks of gestation and who met all of the inclusion and none of the exclusion criteria were enrolled into the study upon signing informed consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Postplacental Insertion of Intrauterine Device (IUD)', 'description': 'This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group.\n\nIUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<20 years old', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '20-29 years old', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}, {'title': '30-39 years old', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': '40-49 years old', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Not Specified', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Parity', 'classes': [{'title': 'Nulliparous', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Multiparous', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Nulliparous participants were identified as those who had no previous childbirths and Multiparous participants were defined as those that had at least one previous childbirth.', 'unitOfMeasure': 'Participants'}, {'title': 'Indication', 'classes': [{'title': 'Elective Repeat', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}, {'title': 'Shoulder Dystocia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Macrosomia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Malpresentation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Preeclampsia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Overall count of 91 participants as the indication categories were not considered to be mutually exclusive (i.e., more than 1 indication could have been selected for participants who were not categorized as 'Elective Repeat').\n\nIn this context, indication describes the condition the participant presented with during consent and enrollment into the study.", 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-05', 'studyFirstSubmitDate': '2011-09-21', 'resultsFirstSubmitDate': '2022-10-31', 'studyFirstSubmitQcDate': '2011-09-22', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-06', 'studyFirstPostDateStruct': {'date': '2011-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Expulsion of IUD', 'timeFrame': '6 week postpartum', 'description': 'Number of participants with Expulsion of IUDs placed at time of cesarean delivery.'}], 'secondaryOutcomes': [{'measure': 'Satisfaction of IUD Placement', 'timeFrame': '6 months postpartum', 'description': 'Satisfaction of subjects who received an IUD at time of cesarean delivery was measured based on a telephone survey administered 6 months postpartum. A 4-point Likert scale ("Very Happy/Happy", "Somewhat Happy", "Unsure", "Unhappy") was used to evaluate participants\' attitude toward the IUD.'}, {'measure': 'Number of Participants With Expulsion of IUD', 'timeFrame': '6 months postpartum', 'description': 'Number of participants with Expulsion of IUDs placed at time of cesarean delivery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postpartum IUD', 'Cesarean Delivery', '6 months postpartum', 'satisfaction'], 'conditions': ['Intrauterine Device Expulsion']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery.', 'detailedDescription': "This was a prospective clinical study with 90 patients undergoing cesarean section. After delivery of the placenta, a ParaGard® copper T380A IUD was inserted through the hysterotomy site. IUD placement was confirmed by visualization of the strings at the cervical os or via ultrasound at the 6 week postpartum visit. Subjects also received a phone call 6 months after IUD placement to ascertain physician follow-up and patient satisfaction. This telephone call was to ensure that each subject attended her postpartum visit, had an evaluation of IUD placement and then we performed a survey. This survey used a Likert Scale to measure each subject's satisfaction. The fields included very satisfied, satisfied, somewhat satisfied, neutral, somewhat unsatisfied, unsatisfied and very unsatisfied."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* singleton gestation\n* greater than 35 weeks gestation\n* speaks English or Spanish\n* desires IUD for contraception\n* undergoing a cesarean delivery\n\nExclusion Criteria:\n\n* evidence of chorioamnionitis\n* history of chlamydia within this pregnancy'}, 'identificationModule': {'nctId': 'NCT01439802', 'briefTitle': 'Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Transcesarean IUD Insertion: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': '2007-345-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Copper IUD placement at time Cesarean Delivery (Copper T 380A)', 'type': 'DEVICE', 'otherNames': ['Copper T 380A'], 'description': 'Placement of Paragard IUD at time of Cesarean Delivery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Jacobi Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center, Weiler Division', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Amitasrigowri Murthy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}