Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT01990703
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2013-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BLIS - Breastfeeding Levonorgestrel IUD Study
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': 'david.turok@hsc.utah.edu', 'phone': '801-581-6170', 'title': 'Dr. David Turok', 'organization': 'University of Utah, Department of OBGYN'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Inability to blind, loss to follow-up, and lack of long-term infant and childhood outcomes. We had a smaller final sample than intended despite meeting enrollment goals.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Early IUD Insertion Group', 'description': 'Immediate post-placental placement of the levonorgestrel IUD\n\nLevonorgestrel IUD: Timing of IUD insertion', 'otherNumAtRisk': 147, 'otherNumAffected': 1, 'seriousNumAtRisk': 147, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Standard Postpartum Insertion Group', 'description': 'Placement of the levonorgestrel IUD 4-6 weeks postpartum\n\nLevonorgestrel IUD: Timing of IUD insertion', 'otherNumAtRisk': 138, 'otherNumAffected': 0, 'seriousNumAtRisk': 138, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cholangitis', 'notes': 'Participant hospitalized for acute cholangitis with stone removal surgery performed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Suicidal behavior', 'notes': 'Participant hospitalized for suicidal behavior and lacerations after a history of severe recurrent depression.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Breastfeeding Continuation Rates at 8 Weeks Postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early IUD Insertion Group', 'description': 'Immediate post-placental placement of the levonorgestrel IUD\n\nLevonorgestrel IUD: Timing of IUD insertion'}, {'id': 'OG001', 'title': 'Standard Postpartum Insertion Group', 'description': 'Placement of the levonorgestrel IUD 4-6 weeks postpartum\n\nLevonorgestrel IUD: Timing of IUD insertion'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks postpartum', 'description': 'To determine breastfeeding continuation rates at 8 weeks in women randomized to immediate post-placental vs. delayed (4-8 weeks) postpartum levonorgestrel IUD insertion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '147 Early IUD Insertion participants at baseline drops to 112 at 8 weeks due to exclusions for medical complications (n=15), inability to provide immediate IUD (n=7) and loss to follow up (n=13). In the Standard Insertion group 138 at baseline drops to 102 at 8 weeks with medical comps (n=11), failure to receive IUD (n=24), and 1 loss to follow up.'}, {'type': 'SECONDARY', 'title': 'Time to Lactogenesis Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early IUD Insertion Group', 'description': 'Immediate post-placental placement of the levonorgestrel IUD\n\nLevonorgestrel IUD: Timing of IUD insertion'}, {'id': 'OG001', 'title': 'Standard Postpartum Insertion Group', 'description': 'Placement of the levonorgestrel IUD 4-6 weeks postpartum\n\nLevonorgestrel IUD: Timing of IUD insertion'}], 'classes': [{'categories': [{'measurements': [{'value': '65.3', 'spread': '25.7', 'groupId': 'OG000'}, {'value': '63.6', 'spread': '21.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First 5 days after birth', 'description': 'To evaluate potential delay in lactogenesis caused by immediate postpartum insertion of the LNG IUD.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Early IUD Insertion Group', 'description': 'Immediate post-placental placement of the levonorgestrel IUD\n\nLevonorgestrel IUD: Timing of IUD insertion'}, {'id': 'FG001', 'title': 'Standard Postpartum Insertion Group', 'description': 'Placement of the levonorgestrel IUD 4-6 weeks postpartum\n\nLevonorgestrel IUD: Timing of IUD insertion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '93'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '45'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Early IUD Insertion Group', 'description': 'Immediate post-placental placement of the levonorgestrel IUD\n\nLevonorgestrel IUD: Timing of IUD insertion'}, {'id': 'BG001', 'title': 'Standard Postpartum Insertion Group', 'description': 'Placement of the levonorgestrel IUD 4-6 weeks postpartum\n\nLevonorgestrel IUD: Timing of IUD insertion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '28.1', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '28.4', 'spread': '5.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 285}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2013-11-15', 'resultsFirstSubmitDate': '2017-03-27', 'studyFirstSubmitQcDate': '2013-11-15', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-16', 'studyFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breastfeeding Continuation Rates at 8 Weeks Postpartum', 'timeFrame': '8 weeks postpartum', 'description': 'To determine breastfeeding continuation rates at 8 weeks in women randomized to immediate post-placental vs. delayed (4-8 weeks) postpartum levonorgestrel IUD insertion.'}], 'secondaryOutcomes': [{'measure': 'Time to Lactogenesis Stage 2', 'timeFrame': 'First 5 days after birth', 'description': 'To evaluate potential delay in lactogenesis caused by immediate postpartum insertion of the LNG IUD.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Contraception', 'Birth Control', 'Levonorgestrel IUD', 'Mirena IUD'], 'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '33478494', 'type': 'DERIVED', 'citation': 'Hopelian NG, Simmons RG, Sanders JN, Ward K, Jenkins SM, Espey E, Turok DK. Comparison of levonorgestrel level and creamatocrit in milk following immediate versus delayed postpartum placement of the levonorgestrel IUD. BMC Womens Health. 2021 Jan 21;21(1):33. doi: 10.1186/s12905-021-01179-7.'}]}, 'descriptionModule': {'briefSummary': 'We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the IUD placed immediately after delivery of the baby and placenta or 4-6 weeks later. We do not believe there will be a difference in breastfeeding 8 weeks after delivery between those who get the IUD placed early or later.', 'detailedDescription': "Increasing use of the levonorgestrel intrauterine device (LNG IUD) has become a cornerstone of U.S. efforts to decrease our nation's high rate of unplanned pregnancy. Many women initiate use of this method in the post partum period. The major advantage of immediate postplacental LNG IUD insertion is the prompt initiation of a highly effective contraceptive method at a time that does not interfere with the intense demands of newborn care, but any contraceptive method initiated in the postpartum period must not interfere with breastfeeding.\n\nOur long-term goal is to understand the impact of hormonal contraceptives, initiated early in the postpartum period, on breastfeeding. The central hypothesis is that quality of breastfeeding is not negatively affected by progestin-only hormonal contraceptives.\n\nWe will pursue three specific aims comparing women randomized to immediate post-placental vs. delayed (4-6 week) postpartum LNG IUD insertion:\n\nAim #1: To determine breastfeeding continuation rates at 8 weeks in both groups Aim #2: To determine timing of lactogenesis in both groups Aim #3: To assess breastfeeding continuation, exclusivity, and satisfaction as well as continuation and satisfaction with the LNG IUD at 26 weeks postpartum in both groups\n\nThis proposal will support a non-inferiority RCT where participants will be randomly assigned to immediate postplacental insertion (within 10 minutes of placental delivery) or delayed postpartum insertion (4-6 weeks postpartum). This project will provide needed evidence on breastfeeding impact of early postpartum initiation of the LNG IUD."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, 18-40 year old pregnant women\n* Intend to breastfeed\n* Desire the LNG IUD as their method of contraception\n* Agree to be randomized to early versus standard postpartum insertion\n* Have delivered a healthy term infant (37 weeks gestation)\n* Willing to complete all study related procedures, visits and questionnaires\n\nExclusion Criteria:\n\n* Chorioamnionitis\n* Obstetric complications including transfusion\n* Severe pregnancy induced hypertension\n* Prolonged hospitalization\n* Coagulopathy\n* Liver disease\n* Undiagnosed genital bleeding, or other relative contraindication to LNG IUD insertion (known or suspected pregnancy, uterine cavity abnormality, known, suspected, or history of breast cancer, or hypersensitivity to any of the components in the LNG IUD).'}, 'identificationModule': {'nctId': 'NCT01990703', 'acronym': 'BLIS', 'briefTitle': 'BLIS - Breastfeeding Levonorgestrel IUD Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Randomized Controlled Trial of Early Versus Standard Postpartum Insertion of the Levonorgestrel IUD to Assess Breast Feeding Outcomes (BLIS - Breastfeeding Levonorgestrel IUD Study)', 'orgStudyIdInfo': {'id': '62844'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early IUD Insertion Group', 'description': 'Immediate post-placental placement of the levonorgestrel IUD', 'interventionNames': ['Drug: Levonorgestrel IUD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Postpartum Insertion Group', 'description': 'Placement of the levonorgestrel IUD 4-6 weeks postpartum', 'interventionNames': ['Drug: Levonorgestrel IUD']}], 'interventions': [{'name': 'Levonorgestrel IUD', 'type': 'DRUG', 'otherNames': ['Mirena'], 'description': 'Timing of IUD insertion', 'armGroupLabels': ['Early IUD Insertion Group', 'Standard Postpartum Insertion Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Health Sciences Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'David K Turok, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah Department of Obstetrics & Gynecology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Family Planning', 'class': 'OTHER'}, {'name': 'University of New Mexico', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'David Turok', 'investigatorAffiliation': 'University of Utah'}}}}