Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-03-14 @ 8:39 AM
Study NCT ID:
NCT02121067
Status:
COMPLETED
Last Update Posted:
2017-08-24
First Post:
2014-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LNG-IUS at 2 Weeks Postpartum
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016912', 'term': 'Levonorgestrel'}], 'ancestors': [{'id': 'D009644', 'term': 'Norgestrel'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mzerden@gmail.com', 'phone': '6179352394', 'title': 'Matthew Zerden, MD, MPH', 'organization': 'University of North Carolina'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'LNG-IUS Placed at 2 Weeks Postpartum', 'description': 'Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum\n\nLevonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LNG-IUS Placed at 2 Weeks Postpartum', 'description': 'Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum\n\nLevonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months postpartum', 'description': 'A dichotomous, yes/no answer to the following question "Would you recommend Mirena placement at two-weeks postpartum to a friend?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 50 participants who enrolled, only 43 were available at 6 months postpartum to provide data for the first primary outcome.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LNG-IUS Placed at 2 Weeks Postpartum', 'description': 'Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum\n\nLevonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14-20 postpartum', 'description': 'Was the LNG-IUS successfully placed in the study period, as determined by whether the participant had an LNG-IUS placed on the day of insertion?', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LNG-IUS Placed at 2 Weeks Postpartum', 'description': 'Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum\n\nLevonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months postpartum', 'description': 'Expulsion will be defined as any of the following (1) patient report that the LNG-IUS came out, (2) ultrasound evaluation that demonstrates the LNG-IUS is not intrauterine (3) ultrasound or clinical evaluation that demonstrates the majority of the LNG-IUS is located in the cervix.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 50 participants who enrolled and had an LNG-IUS placed at 2 weeks postpartum, only 43 were available at 6 months postpartum to provide data for expulsion.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LNG-IUS Placed at 2 Weeks Postpartum', 'description': 'Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum\n\nLevonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'LNG-IUS Placed at 2 Weeks Postpartum', 'description': 'Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum\n\nLevonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-24', 'studyFirstSubmitDate': '2014-03-24', 'resultsFirstSubmitDate': '2017-04-24', 'studyFirstSubmitQcDate': '2014-04-21', 'lastUpdatePostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-24', 'studyFirstPostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.', 'timeFrame': '6 months postpartum', 'description': 'A dichotomous, yes/no answer to the following question "Would you recommend Mirena placement at two-weeks postpartum to a friend?"'}, {'measure': 'Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period.', 'timeFrame': 'Day 14-20 postpartum', 'description': 'Was the LNG-IUS successfully placed in the study period, as determined by whether the participant had an LNG-IUS placed on the day of insertion?'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months.', 'timeFrame': '6 months postpartum', 'description': 'Expulsion will be defined as any of the following (1) patient report that the LNG-IUS came out, (2) ultrasound evaluation that demonstrates the LNG-IUS is not intrauterine (3) ultrasound or clinical evaluation that demonstrates the majority of the LNG-IUS is located in the cervix.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['postpartum', 'contraception', 'intrauterine device', 'intrauterine system', 'mirena', 'uterine involution'], 'conditions': ['Contraception', 'Malposition of Intrauterine Contraceptive Device']}, 'referencesModule': {'references': [{'pmid': '27554014', 'type': 'DERIVED', 'citation': 'Zerden ML, Stuart GS, Charm S, Bryant A, Garrett J, Morse J. Two-week postpartum intrauterine contraception insertion: a study of feasibility, patient acceptability and short-term outcomes. Contraception. 2017 Jan;95(1):65-70. doi: 10.1016/j.contraception.2016.08.005. Epub 2016 Aug 20.'}]}, 'descriptionModule': {'briefSummary': 'This is a study of 50 postpartum women interested in having the Mirena® LNG-IUS placed for contraception. The Mirena® is an FDA approved intrauterine contraceptive device that provides contraception for 5 years with excellent effectiveness. Women enrolled in this study will only have the Mirena® placed at two-weeks postpartum (day 14-20 postpartum). The participants will be followed at 6-weeks and 6-months postpartum for study visits to evaluate for satisfaction, symptoms, expulsion, and perforation. The study will be completed at six-months postpartum, and participants will be able to keep their LNG-IUS following study completion.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Desiring a LNG-IUS\n2. Postpartum, ages 18-45 who deliver at a gestational age \\> 32 weeks, delivery can be via cesarean or vaginal delivery\n3. Following a viable, singleton pregnancy\n4. Willing to return to UNC for their LNG-IUS insertion and study follow-up\n5. Who plan to stay in the UNC area for 6 months and willing to return to UNC for 3 visits\n6. Fluent in English or Spanish\n7. At risk of repeat pregnancy (i.e. excluding those who had tubal sterilization)\n\nExclusion Criteria:\n\n1. No genital bleeding of unknown etiology\n2. No personal history of known or suspected breast carcinoma\n3. No 4th degree vaginal laceration at time of delivery\n4. No documented uterine rupture during delivery\n5. No active liver disease (resolved pre-eclampsia may enroll)\n6. No evidence of vaginal, cervical or uterine infection at time of LNG-IUS insertion\n7. No history of postpartum endometritis treated with antibiotics or a postpartum readmission for a dilation and curettage\n8. No pre-existing contraindication to a LNG-IUS as determined by the CDC's Medical Eligibility Criteria (MEC) category 3 or 4\n9. Not currently incarcerated\n10. No known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity\n11. No suspected hypersensitivity or contraindication to the LNG-IUS\n12. With any other condition or circumstance that the PI determines could cause an adverse event or interfere with completing the study."}, 'identificationModule': {'nctId': 'NCT02121067', 'acronym': 'LNG-IUS', 'briefTitle': 'LNG-IUS at 2 Weeks Postpartum', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Intrauterine Contraceptive Insertion at Two-weeks Postpartum: A Study of Acceptability and Short-term Outcomes', 'orgStudyIdInfo': {'id': '14-0202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LNG-IUS placed at 2 weeks postpartum', 'description': 'Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum', 'interventionNames': ['Drug: Levonorgestrel Intrauterine System (LNG-IUS)']}], 'interventions': [{'name': 'Levonorgestrel Intrauterine System (LNG-IUS)', 'type': 'DRUG', 'otherNames': ['Mirena'], 'description': 'The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled', 'armGroupLabels': ['LNG-IUS placed at 2 weeks postpartum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Matthew L Zerden, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNCH'}, {'name': 'Gretchen S Stuart, MD', 'role': 'STUDY_DIRECTOR', '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': 'SPONSOR'}}}}