Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-25 @ 11:02 PM
Study NCT ID:
NCT00997932
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2009-09-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot Study of Early Postpartum Intrauterine Contraception
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013995', 'term': 'Time'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gstuart@med.unc.edu', 'phone': '919-962-4880', 'title': 'Dr. G Stuart', 'organization': 'University of North Carolina School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Immediate Insertion', 'description': 'Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.\n\nMirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No IUD Insertion', 'description': 'Women in this group underwent baseline data collection, stated they would like to enroll and receive an IUD between 10 minutes and 48 hours postpartum. These women were not eligible to receive the IUD due to delivery elsewhere, medical complications in peri-partum period.', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'IUD Expulsion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Insertion', 'description': 'Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.\n\nMirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From time of insertion to final study date which is 6 months after IUD insertion.', 'description': 'Expulsion of the LNG-IUS', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Immediate Insertion', 'description': 'Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.\n\nMirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Immediate Insertion', 'description': 'Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.\n\nMirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '29'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The results are presented for the 29 women who received the IUD. Baseline data are presented for the 29 women who received the IUD and the 11 women who did not.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'females only because this was a female contraception study', 'unitOfMeasure': 'Participants', 'populationDescription': 'All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Black', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race White Black Other Hispanic ethnicity', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous contraceptive use, marital status, employment,', 'classes': [{'title': 'Employed', 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Married or Cohabitating', 'categories': [{'title': 'Yes', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Prior use of contraception', 'categories': [{'title': 'Yes', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-28', 'studyFirstSubmitDate': '2009-09-28', 'resultsFirstSubmitDate': '2017-01-11', 'studyFirstSubmitQcDate': '2009-10-16', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-28', 'studyFirstPostDateStruct': {'date': '2009-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IUD Expulsion', 'timeFrame': 'From time of insertion to final study date which is 6 months after IUD insertion.', 'description': 'Expulsion of the LNG-IUS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['levonorgestrel releasing intrauterine device', 'levonorgestrel releasing intrauterine contraception', 'unintended pregnancy prevention', 'postpartum contraception'], 'conditions': ['Unplanned Pregnancy']}, 'descriptionModule': {'briefSummary': 'This is a prospective clinical trial of ultrasound guided intrauterine contraception insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months.\n\nThe objective of this study is to measure intrauterine device (IUD) expulsion and the feasibility of conducting a future clinical trial to evaluate placement of the levonorgestrel-releasing intrauterine contraceptive 10 minutes - 48 hours postpartum.', 'detailedDescription': 'This was a single arm cohort study of women who desired to receive a levonorgestrel releasing intrauterine system (LNG-IUS) within 48 hours of uncomplicated vaginal delivery.\n\nWomen were enrolled during a prenatal care visit when they reported they desired to use the LNG-IUS after the birth of their infant.\n\nForty women stated enrolled in the study prior to labor, and baseline data were obtained. After delivery 29 women remained both interested in the study and were still eligible to receive the LNG-IUS prior to discharge from the hospital.\n\nOf the 29 women who received the LNG-IUS prior to discharge from the hospital 11 women had an LNG-IUS expulsion prior to 6 months postpartum.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently pregnant with a single gestation of at least 27 completed weeks estimated gestational age, with no complications of pregnancy including, but not limited to, preeclampsia, non-gestational diabetes, anemia.\n* Desires to use intrauterine contraception (IUD) after delivery\n* Anticipates having a vaginal delivery\n* No intention to leave the area 7 months after enrollment\n* Able to consent to participate in the study in English\n* Has no known uterine anomalies\n* Has no allergies to any components of the intrauterine contraception\n\nExclusion Criteria:\n\n* Prior cesarean delivery\n* Having been treated for pelvic inflammatory disease within 3 months prior to the start of the pregnancy\n* Allergic to betadine\n* Allergy to lidocaine\n* Medical or personal conditions which in the judgment of study staff contradict participation in the study\n* Any contraindications to use of the levonorgestrel-releasing intrauterine contraceptive system which includes: known or suspected breast carcinoma, acute liver disease or liver tumor, history of ectopic pregnancy, cervical cancer or carcinoma in situ\n* After enrollment, and after delivery of the infant but before IUD insertion subjects will be excluded by checking with the attending obstetric physician and/or obstetric medical chart for the following:\n\n * Endometritis or chorioamnionitis during the intrapartum period\n * Membranes ruptured for greater than 24 hours prior to delivery\n * Fever greater than or equal to 38C\n * The need to use additional medications other than pitocin and/or misoprostol to control postpartum bleeding'}, 'identificationModule': {'nctId': 'NCT00997932', 'acronym': 'ImmPPIUD', 'briefTitle': 'A Pilot Study of Early Postpartum Intrauterine Contraception', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'A Pilot Study of Early Postpartum Intrauterine Contraception', 'orgStudyIdInfo': {'id': 'SFP3-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Complete Cohort', 'description': 'The complete cohort of all women enrolled and stated they wanted an LNG-IUS between 48 and 72 hours of vaginal delivery.', 'interventionNames': ['Drug: Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration']}], 'interventions': [{'name': 'Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration', 'type': 'DRUG', 'otherNames': ['LNG-IUS'], 'description': 'Levonorgestrel-Releasing Intrauterine Contraceptive System, 52 Mg, 5 Year Duration Postpartum placement of LNG-IUS within 10 minutes - 48 hours', 'armGroupLabels': ['Complete Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27514', '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': 'Gretchen Stuart, MD, MPHTM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Gretchen Stuart, MD', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}