Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-03-06 @ 10:10 PM
Study NCT ID:
NCT01272960
Status:
COMPLETED
Last Update Posted:
2017-12-02
First Post:
2011-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lmharper@uabmc.edu', 'phone': '205-975-0515', 'title': 'Dr. Lorie Harper', 'organization': 'University of Alabama School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Inability to recruit and randomize our target sample size, to detect rare adverse events that may be associated with immediate insertion, women randomized to immediate insertion were more likely to return for their 6-month string check visit.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Interval Insertion', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Post Placental Mirena Insertion', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Infection', 'notes': 'One LNG-IUS was removed in the immediate insertion group and not replaced due to a systemic Group B streptococcus infection diagnosed within 6-weeks post-partum.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mirena in Place', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Post Placental Mirena Insertion'}, {'id': 'OG001', 'title': 'Interval Insertion'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Proportion of women in each arm with Mirena in place at 6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mirena Expulsion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interval Insertion', 'description': 'Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.\n\nPost-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta'}, {'id': 'OG001', 'title': 'Post-Placental Mirena Insertion', 'description': 'Will receive Mirena insertion within 10 minutes of delivery of placenta\n\nPost-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'The percentage of patients with post-placental placement of Mirena who experience an expulsion', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Uterine Perforation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interval Insertion', 'description': 'Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.\n\nInterval Insertion: Insertion of Mirena 4-8 weeks post partum after vaginal delivery'}, {'id': 'OG001', 'title': 'Post-Placental Mirena Insertion', 'description': 'Will receive Mirena insertion within 10 minutes of delivery of placenta\n\nPost-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The proportion of patients in each arm who experience a uterine perforation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intrauterine Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interval Insertion', 'description': 'Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.\n\nPost-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta'}, {'id': 'OG001', 'title': 'Post-Placental Mirena Insertion', 'description': 'Will receive Mirena insertion within 10 minutes of delivery of placenta\n\nPost-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The proportion of patients in each arm who experience an intrauterine infection (endometritis, pelvic inflammatory disease)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interval Insertion', 'description': 'Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.\n\nPost-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta'}, {'id': 'FG001', 'title': 'Post-Placental Mirena Insertion', 'description': 'Will receive Mirena insertion within 10 minutes of delivery of placenta\n\nPost-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '53 participants were enrolled but only 29 randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Interval Insertion', 'description': '14 subjects received Mirena at 4-8 weeks post-partum after vaginal delivery.'}, {'id': 'BG001', 'title': 'Post-Placental Mirena Insertion', 'description': '15 received Mirena insertion within 10 minutes of delivery of placenta'}, {'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': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', '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': '26.1', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '26.9', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '26.6', 'spread': '5.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', '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': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of pregnancies at viable gestational age', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Pregnancies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2011-01-06', 'resultsFirstSubmitDate': '2016-05-16', 'studyFirstSubmitQcDate': '2011-01-07', 'lastUpdatePostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-24', 'studyFirstPostDateStruct': {'date': '2011-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mirena in Place', 'timeFrame': '6 months', 'description': 'Proportion of women in each arm with Mirena in place at 6 months'}], 'secondaryOutcomes': [{'measure': 'Mirena Expulsion', 'timeFrame': '6 weeks', 'description': 'The percentage of patients with post-placental placement of Mirena who experience an expulsion'}, {'measure': 'Uterine Perforation', 'timeFrame': '6 months', 'description': 'The proportion of patients in each arm who experience a uterine perforation'}, {'measure': 'Intrauterine Infection', 'timeFrame': '6 months', 'description': 'The proportion of patients in each arm who experience an intrauterine infection (endometritis, pelvic inflammatory disease)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contraception', 'Postnatal care'], 'conditions': ['Postpartum Period']}, 'referencesModule': {'references': [{'pmid': '16772190', 'type': 'BACKGROUND', 'citation': 'Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health. 2006 Jun;38(2):90-6. doi: 10.1363/psrh.38.090.06.'}, {'pmid': '7409230', 'type': 'BACKGROUND', 'citation': 'Gillett PG, Lee NH, Yuzpe AA, Cerskus I. A comparison of the efficacy and acceptability of the Copper-7 intrauterine device following immediate or delayed insertion after first-trimester therapeutic abortion. Fertil Steril. 1980 Aug;34(2):121-4. doi: 10.1016/s0015-0282(16)44893-4. No abstract available.'}, {'pmid': '8293847', 'type': 'BACKGROUND', 'citation': 'Sivin I, Stern J. Health during prolonged use of levonorgestrel 20 micrograms/d and the copper TCu 380Ag intrauterine contraceptive devices: a multicenter study. International Committee for Contraception Research (ICCR). Fertil Steril. 1994 Jan;61(1):70-7. doi: 10.1016/s0015-0282(16)56455-3.'}, {'pmid': '7418410', 'type': 'BACKGROUND', 'citation': 'Comparative multicentre trial of three IUDs inserted immediately following delivery of the placenta. Contraception. 1980 Jul;22(1):9-18. doi: 10.1016/0010-7824(80)90112-2.'}, {'pmid': '4006467', 'type': 'BACKGROUND', 'citation': 'Thiery M, Van Kets H, Van der Pas H. Immediate post-placental IUD insertion: the expulsion problem. Contraception. 1985 Apr;31(4):331-49. doi: 10.1016/0010-7824(85)90002-2.'}, {'pmid': '8631184', 'type': 'BACKGROUND', 'citation': 'Morrison C, Waszak C, Katz K, Diabate F, Mate EM. Clinical outcomes of two early postpartum IUD insertion programs in Africa. Contraception. 1996 Jan;53(1):17-21. doi: 10.1016/0010-7824(95)00254-5.'}, {'pmid': '8030457', 'type': 'BACKGROUND', 'citation': "Xu JX, Reusche C, Burdan A. Immediate postplacental insertion of the intrauterine device: a review of Chinese and the world's experiences. Adv Contracept. 1994 Mar;10(1):71-82. doi: 10.1007/BF01986532."}, {'pmid': '1680090', 'type': 'BACKGROUND', 'citation': 'Zhou SW, Chi IC. Immediate postpartum IUD insertions in a Chinese hospital--a two year follow-up. Int J Gynaecol Obstet. 1991 Jun;35(2):157-64. doi: 10.1016/0020-7292(91)90820-u.'}, {'pmid': '17046378', 'type': 'BACKGROUND', 'citation': 'Eroglu K, Akkuzu G, Vural G, Dilbaz B, Akin A, Taskin L, Haberal A. Comparison of efficacy and complications of IUD insertion in immediate postplacental/early postpartum period with interval period: 1 year follow-up. Contraception. 2006 Nov;74(5):376-81. doi: 10.1016/j.contraception.2006.07.003. Epub 2006 Sep 15.'}, {'pmid': '20966692', 'type': 'BACKGROUND', 'citation': 'Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, Creinin MD. Postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2010 Nov;116(5):1079-87. doi: 10.1097/AOG.0b013e3181f73fac.'}]}, 'descriptionModule': {'briefSummary': 'In order to determine the timing of LNG-IUS insertion that results in a greater proportion of women using the LNG-IUS at 6-months post-partum, we will perform a randomized control trial of interval versus immediate post-placenta insertion. Women will be enrolled at 36-weeks gestation and greater. At the time of vaginal delivery, women will be randomized to receive either immediate post-placenta insertion of the LNG-IUS or routine insertion at 4-8 weeks post-partum. All patients will return at 4-6 weeks post-insertion and 6 months post-partum to confirm correct position of the LNG-IUS. The primary outcome of this sub-study is the number of LNG-IUS in the correct position at 6-months. Secondary outcomes include assessing the safety of post-placental LNG-IUS insertion and difference in acceptability and symptoms experienced by participants. This is a sub-study of the Contraceptive Choice Project, a prospective cohort study that aims to improve the use of long-acting contraception by removing financial barriers which has already enrolled over 5,000 patients. Association of this study with CHOICE offers unique advantages including infrastructure to support subject recruitment, retention and completion of follow-up as well as covering the cost of LNG-IUS devices.\n\nWe hypothesize that, despite higher expulsion rates, women randomized to receive the LNG-IUS immediately after placenta delivery will have higher rates of LNG-IUS continuation due to poor rates of follow up in the interval insertion group. This is likely to be particularly noticeable in our patient population, which is largely uninsured with poor access to healthcare. Further, typical symptoms of LNG-IUS insertion include bleeding and cramping, which may be disguised by the post-partum period. Published reports of immediate post-placenta insertion focus on expulsion rates and do not report on symptoms and satisfaction rates.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 14-45 years\n* Vaginal Delivery at Barnes-Jewish Hospital\n* Sexually active with male partner\n* No tubal ligation/hysterectomy\n* Not currently using contraception\n* Desire reversible contraception\n* Reside in St. Louis City/County\n* Requests Mirena(R) intrauterine device for contraception\n\nExclusion Criteria:\n\n* Allergy to Mirena(R) system\n* Cesarean delivery\n* Cervical cancer, breast cancer\n* Active liver disease\n* Untreated cervicitis\n* Uterine anomaly/fibroids preventing Mirena(R) placement\n* Delivery \\<36 weeks\n* Chorioamnionitis\n* Prolonged rupture of membranes (\\>18 hours)'}, 'identificationModule': {'nctId': 'NCT01272960', 'acronym': 'MISTIC', 'briefTitle': 'Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Randomized, Open-label, Controlled Trial of Immediate Postpartum Versus Interval Insertion of Mirena to Increase the Usage at 6 Months After Delivery', 'orgStudyIdInfo': {'id': 'SFP4-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interval Insertion', 'description': 'Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.', 'interventionNames': ['Device: Interval Insertion']}, {'type': 'EXPERIMENTAL', 'label': 'Post-Placental Mirena Insertion', 'description': 'Will receive Mirena insertion within 10 minutes of delivery of placenta', 'interventionNames': ['Device: Post-Placenta Mirena Insertion']}], 'interventions': [{'name': 'Post-Placenta Mirena Insertion', 'type': 'DEVICE', 'description': 'Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta', 'armGroupLabels': ['Post-Placental Mirena Insertion']}, {'name': 'Interval Insertion', 'type': 'DEVICE', 'description': 'Insertion of Mirena 4-8 weeks post partum after vaginal delivery', 'armGroupLabels': ['Interval Insertion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Lorie M Harper, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}