Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-02-23 @ 11:11 PM
Study NCT ID:
NCT02169869
Status:
TERMINATED
Last Update Posted:
2019-05-01
First Post:
2014-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immediate Postplacental IUD Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mccrimmo@ohsu.edu', 'phone': '5034940757', 'title': 'Ob/Gyn Regulatory Specialist', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Immediate Postplacental IUD Insertion', 'description': 'Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery.\n\nMirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.\n\nParagard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '6 Weeks Postpartum IUD Insertion', 'description': 'Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider.\n\nMirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.\n\nParagard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects With an IUD at 3 Months Postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Postplacental IUD Insertion', 'description': 'Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery.\n\nMirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.\n\nParagard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.'}, {'id': 'OG001', 'title': '6 Weeks Postpartum IUD Insertion', 'description': 'Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider.\n\nMirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.\n\nParagard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months postpartum (after delivery)', 'description': 'Subjects were contacted at 3 months after delivery. Comparison of the proportion of women randomized to placement of IUD within 60 minutes of placental delivery or at their 6-week routine postpartum visit who report having an IUD in place at 3 months after delivery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Immediate Postplacental IUD Insertion', 'description': 'Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery.\n\nMirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.\n\nParagard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.'}, {'id': 'FG001', 'title': '6 Weeks Postpartum IUD Insertion', 'description': 'Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider.\n\nMirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.\n\nParagard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Immediate Postplacental IUD Insertion', 'description': 'Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery.\n\nMirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.\n\nParagard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.'}, {'id': 'BG001', 'title': '6 Weeks Postpartum IUD Insertion', 'description': 'Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider.\n\nMirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.\n\nParagard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], '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': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', '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': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-16', 'size': 663714, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-08T14:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized-controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'whyStopped': 'Change in local healthcare policies and practices', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-08', 'studyFirstSubmitDate': '2014-06-19', 'resultsFirstSubmitDate': '2019-04-08', 'studyFirstSubmitQcDate': '2014-06-20', 'lastUpdatePostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-08', 'studyFirstPostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Subjects With an IUD at 3 Months Postpartum', 'timeFrame': '3 months postpartum (after delivery)', 'description': 'Subjects were contacted at 3 months after delivery. Comparison of the proportion of women randomized to placement of IUD within 60 minutes of placental delivery or at their 6-week routine postpartum visit who report having an IUD in place at 3 months after delivery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intrauterine device, postpartum, contraception, Mirena, Paragard, intrauterine system'], 'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': "The study will be a randomized clinical trial. Women with less than 10 prenatal visits and/or 2 or more no show visits who desire an Intrauterine Device (IUD) will be considered for enrollment. If consented and meet inclusion criteria, they will be randomized after delivery to receive an IUD immediately postplacental or at their routine postpartum visit.\n\nWomen who plan to deliver a live birth singleton via vaginal or cesarean delivery at Oregon Health and Science University (OHSU) hospital will be considered for inclusion in the study. Women who desire an IUD for postpartum contraception will be approached for study participation. The postpartum contraception plan is routinely documented during their prenatal course. It is also addressed by the obstetrical team upon admission to Labor \\& Delivery at OHSU. The obstetrical team will identify subjects who present in labor who meet the criteria of poor prenatal clinic attendance and express interest in intrauterine contraception. Immediately after vaginal or cesarean delivery, consented subjects will be randomized to immediate postplacental IUD placement or IUD placement at their routine postpartum visit. Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery. Prior to discharge from the hospital women who received a postplacental IUD will be assisted in scheduling a routine postpartum visit with their primary provider. Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider. All subjects in the delayed group will be provided with contact information for the Women's Health Research Unit (WHRU) at OHSU. If a subject cannot obtain an IUD at her usual place of care, the device will be placed at no cost through the WHRU.\n\nAt 3 months after delivery, all subjects will be contacted by phone, text, or email to complete a questionnaire to determine whether they have had a known expulsion, pregnancy, or elective IUD removal. The questionnaire will include questions regarding ease of placement and overall satisfaction with the timing of placement. Subjects will be compensated for their participation in the study after the 3 month contact."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female\n* 18 yo or older\n* Singleton pregnancy at ≥32 weeks gestation at time of enrollment\n* Voluntarily requesting either copper T380A or levonorgestrel IUD (LNG-IUS) placement for postpartum contraception\n* English or Spanish speaking\n* Able to give consent and agree to the terms of the study\n* Less than 10 prenatal visits or 2 or more no show visits\n* Since IUDs are not on our hospital formulary, the patient must qualify for a Long Acting Reversible Contraceptive (LARC) IUD (this includes all Oregon Health Plan (OHP) or Citizen/Alien Waived Emergent Medical (CAWEM) insured patients or women with income \\<300% of the federal poverty line).\n\nExclusion Criteria:\n\n* Anatomic uterine abnormalities that prevent proper fundal placement of IUD (obstructive myomata, bicornuate, septate, etc)\n* Chorioamnionitis (also consider other risk factors such as prolonged rupture of membranes \\>18 hours, prolonged labor \\>24 hours, fever \\>38C)\n* Puerperal sepsis\n* Unresolved postpartum hemorrhage\n* Extensive genital trauma\n* Current incarceration\n* Known or suspected untreated endocervical gonorrhea, chlamydia\n* Wilson's disease, copper allergy (Paragard only)\n* Known or suspected cervical or endometrial cancer or pelvic tuberculosis\n* Current breast cancer (LNG-IUS only)\n* Systemic lupus erythematosus (SLE) with severe thrombocytopenia (Paragard only)\n* Trophoblastic disease (benign or malignant)\n* AIDS not stable on antiretroviral"}, 'identificationModule': {'nctId': 'NCT02169869', 'briefTitle': 'Immediate Postplacental IUD Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Immediate Postplacental Intrauterine Device Insertion in High-risk Patient Populations', 'orgStudyIdInfo': {'id': 'OHSU IRB #10473'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate postplacental IUD insertion', 'description': 'Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery.', 'interventionNames': ['Device: Mirena', 'Device: Paragard']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6 weeks postpartum IUD insertion', 'description': 'Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider.', 'interventionNames': ['Device: Mirena', 'Device: Paragard']}], 'interventions': [{'name': 'Mirena', 'type': 'DEVICE', 'otherNames': ['levonorgestrel intrauterine system'], 'description': 'A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.', 'armGroupLabels': ['6 weeks postpartum IUD insertion', 'Immediate postplacental IUD insertion']}, {'name': 'Paragard', 'type': 'DEVICE', 'otherNames': ['Copper T380A IUD'], 'description': 'A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.', 'armGroupLabels': ['6 weeks postpartum IUD insertion', 'Immediate postplacental IUD insertion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Jeffrey Jensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Director', 'investigatorFullName': 'Jeffrey Jensen', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}