Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT03462758
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2018-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Early vs. Interval Postpartum IUD Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'familyplanningresearch@health.ucsd.edu', 'phone': '858-329-4464', 'title': 'Dr. Sarah Averbach, MD, MAS', 'organization': 'University of California, San Diego'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 Months', 'eventGroups': [{'id': 'EG000', 'title': 'Interval Postpartum IUD Placement', 'description': 'IUD placed 6-8 weeks postpartum (standard of care, interval placement)\n\nIUD: Postpartum IUD placement', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 145, 'otherNumAffected': 0, 'seriousNumAtRisk': 145, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Early Postpartum IUD Placement', 'description': 'IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)\n\nIUD: Postpartum IUD placement', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 0, 'seriousNumAtRisk': 149, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With an IUD Expulsion (Complete) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interval Postpartum IUD Placement', 'description': 'IUD placed 6-8 weeks postpartum (standard of care, interval placement)\n\nIUD: Postpartum IUD placement'}, {'id': 'OG001', 'title': 'Early Postpartum IUD Placement', 'description': 'IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)\n\nIUD: Postpartum IUD placement'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months postpartum', 'description': 'Complete IUD expulsion will be defined as an IUD which no longer in the uterus on speculum exam and transvaginal ultrasound will be performed on all patients at 6 months postpartum to confirm IUD use', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intention to treat (MITT) analysis: those who received an IUD within 6 months of delivery whose outcome was known at the end of the study period.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Using an IUD at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interval Postpartum IUD Placement', 'description': 'IUD placed 6-8 weeks postpartum (standard of care, interval placement)\n\nIUD: Postpartum IUD placement'}, {'id': 'OG001', 'title': 'Early Postpartum IUD Placement', 'description': 'IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)\n\nIUD: Postpartum IUD placement'}], 'classes': [{'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months postpartum', 'description': 'IUD utilization will be defined as intrauterine use of an IUD at 6 months postpartum. A speculum exam and transvaginal ultrasound will be performed on all patients at 6 months postpartum to confirm IUD use', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentages based on total study sample rather than MITT analysis.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With an IUD Expulsion (Partial) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interval Postpartum IUD Placement', 'description': 'IUD placed 6-8 weeks postpartum (standard of care, interval placement)\n\nIUD: Postpartum IUD placement'}, {'id': 'OG001', 'title': 'Early Postpartum IUD Placement', 'description': 'IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)\n\nIUD: Postpartum IUD placement'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Partial IUD expulsions will be diagnosed in any participant found to have an IUD in which part of the body of the IUD is noted to be coming through the external cervical os on speculum exam.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intention to treat (MITT) analysis: those who received an IUD within 6 months of delivery whose outcome was known at the end of the study period.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With a Pelvic Infection Within 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interval Postpartum IUD Placement', 'description': 'IUD placed 6-8 weeks postpartum (standard of care, interval placement)\n\nIUD: Postpartum IUD placement'}, {'id': 'OG001', 'title': 'Early Postpartum IUD Placement', 'description': 'IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)\n\nIUD: Postpartum IUD placement'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Pelvic infection requiring antibiotics will be ascertained by patient report and/or medical record review.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intention to treat (MITT) analysis: those who received an IUD within 6 months of delivery whose outcome was known at the end of the study period.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With IUD Assessed on a Five-point "Likert" Scale for Satisfaction, an Ordinal Scale That Measure Levels of Agreement/Disagreement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interval Postpartum IUD Placement', 'description': 'IUD placed 6-8 weeks postpartum (standard of care, interval placement)\n\nIUD: Postpartum IUD placement'}, {'id': 'OG001', 'title': 'Early Postpartum IUD Placement', 'description': 'IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)\n\nIUD: Postpartum IUD placement'}], 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Participants are asked how much they agree with the statement "I am satisfied with using this IUD." Answers are valued 1-5, with 1 Strongly Agree, 2 Agree, 3 Neutral, 4 Disagree, and 5 Strongly Disagree. 1=Strongly Agree is considered the best outcome, 5=Strongly disagree is considered the worst outcome. Outcome reported is those who were very satisfied or satisfied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intention to treat (MITT) analysis: those who received an IUD within 6 months of delivery whose outcome was known at the end of the study period.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With an IUD Perforation at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interval Postpartum IUD Placement', 'description': 'IUD placed 6-8 weeks postpartum (standard of care, interval placement)\n\nIUD: Postpartum IUD placement'}, {'id': 'OG001', 'title': 'Early Postpartum IUD Placement', 'description': 'IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)\n\nIUD: Postpartum IUD placement'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'IUD perforations through the uterus will be diagnosed when an IUD visible is not visible on transvaginal ultrasound of the uterus but is visible on x-ray of the abdomen or pelvis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intention to treat (MITT) analysis: those who received an IUD within 6 months of delivery whose outcome was known at the end of the study period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interval Postpartum IUD Placement', 'description': 'IUD placed 6-8 weeks postpartum (standard of care, interval placement)\n\nIUD: Postpartum IUD placement'}, {'id': 'FG001', 'title': 'Early Postpartum IUD Placement', 'description': 'IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)\n\nIUD: Postpartum IUD placement'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '203'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '54'}]}], 'dropWithdraws': [{'type': 'Chose no or other method of contraception', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Lost to follow-up before IUD placement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Unsuccessful IUD placement attempt', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Medical contraindication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to follow-up after IUD placement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}], 'recruitmentDetails': 'Participants were recruited from inpatient postpartum hospital units of the study sites. The first participant was enrolled on March 26, 2018 and the final participant was enrolled on July 29, 2021.', 'preAssignmentDetails': '404 patients enrolled in the study, all of whom met inclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Interval Postpartum IUD Placement', 'description': 'IUD placed 6-8 weeks postpartum (standard of care, interval placement)\n\nIUD: Postpartum IUD placement'}, {'id': 'BG001', 'title': 'Early Postpartum IUD Placement', 'description': 'IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)\n\nIUD: Postpartum IUD placement'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30.0', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '29.8', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '29.9', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}], 'categories': [{'title': 'High school degree or less', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}, {'title': 'College degree', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Graduate degree', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Full time', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}, {'title': 'Unemployed/Retired', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'Part time', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Student', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of most recent delivery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Vaginal', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}, {'title': 'Cesarean', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Multiparous', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}, {'title': 'Primiparous', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of IUD', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'title': '52-mg levonorgestrel', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}, {'title': 'Copper', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': '19.5-mg/13.5-mg levonorgestrel', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All participants who had an IUD placed at any time between randomization and 6-month follow-up.'}, {'title': 'Ultrasonography used', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'title': 'During placement', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'After placement only', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'None', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All participants who had an IUD placed at any time between randomization and 6-month follow-up.'}, {'title': 'Lactating at time of IUD insertion', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Excluding missing values on lactation status.'}, {'title': 'Clinician performing IUD insertion', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Faculty physician', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}, {'title': 'Advanced practice clinician', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Resident physician', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Excluding missing values on clinician type.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-01', 'size': 377849, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-20T16:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 404}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2018-01-24', 'resultsFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2018-03-05', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-20', 'studyFirstPostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With an IUD Expulsion (Complete) at 6 Months', 'timeFrame': '6 months postpartum', 'description': 'Complete IUD expulsion will be defined as an IUD which no longer in the uterus on speculum exam and transvaginal ultrasound will be performed on all patients at 6 months postpartum to confirm IUD use'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants Using an IUD at 6 Months', 'timeFrame': '6 months postpartum', 'description': 'IUD utilization will be defined as intrauterine use of an IUD at 6 months postpartum. A speculum exam and transvaginal ultrasound will be performed on all patients at 6 months postpartum to confirm IUD use'}, {'measure': 'Proportion of Participants With an IUD Expulsion (Partial) at 6 Months', 'timeFrame': '6 months', 'description': 'Partial IUD expulsions will be diagnosed in any participant found to have an IUD in which part of the body of the IUD is noted to be coming through the external cervical os on speculum exam.'}, {'measure': 'Proportion of Participants With a Pelvic Infection Within 6 Months', 'timeFrame': '6 months', 'description': 'Pelvic infection requiring antibiotics will be ascertained by patient report and/or medical record review.'}, {'measure': 'Patient Satisfaction With IUD Assessed on a Five-point "Likert" Scale for Satisfaction, an Ordinal Scale That Measure Levels of Agreement/Disagreement', 'timeFrame': '6 months', 'description': 'Participants are asked how much they agree with the statement "I am satisfied with using this IUD." Answers are valued 1-5, with 1 Strongly Agree, 2 Agree, 3 Neutral, 4 Disagree, and 5 Strongly Disagree. 1=Strongly Agree is considered the best outcome, 5=Strongly disagree is considered the worst outcome. Outcome reported is those who were very satisfied or satisfied.'}, {'measure': 'Proportion of Participants With an IUD Perforation at 6 Months', 'timeFrame': '6 months', 'description': 'IUD perforations through the uterus will be diagnosed when an IUD visible is not visible on transvaginal ultrasound of the uterus but is visible on x-ray of the abdomen or pelvis.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Mirena', 'ParaGard', 'Skyla', 'Liletta', 'Kyleena', 'Intrauterine Device', 'Intrauterine System', 'Postpartum', 'Expulsion'], 'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '41000085', 'type': 'DERIVED', 'citation': 'Berkley HH, Lutgendorf MA, Kully G, Raiciulescu S, Stortz SK, Hinz E, Hofler LG, Averbach S. Pain With Early Postpartum Intrauterine Device Placement. O G Open. 2025 Jun 12;2(3):e088. doi: 10.1097/og9.0000000000000088. eCollection 2025 Jun.'}, {'pmid': '36943214', 'type': 'DERIVED', 'citation': 'Averbach S, Kully G, Hinz E, Dey A, Berkley H, Hildebrand M, Vaida F, Haider S, Hofler LG. Early vs Interval Postpartum Intrauterine Device Placement: A Randomized Clinical Trial. JAMA. 2023 Mar 21;329(11):910-917. doi: 10.1001/jama.2023.1936.'}]}, 'descriptionModule': {'briefSummary': "Intrauterine devices (IUDs) are historically placed at a six-week postpartum visit for women who desire intrauterine contraception after delivery. A two-week postpartum visit could be a convenient time for women to receive contraception, including IUDs. Offering women IUDs at two-weeks postpartum may decrease the risk of undesired pregnancy and rapid repeat pregnancy. This study will compare IUD insertion at two different times after delivery: two-weeks and six-weeks postpartum. This will allow researchers to assess whether the timing of IUD placement affects whether an IUD is expelled, or pushed out of it's ideal location.", 'detailedDescription': 'The purpose of this study is to determine the proportion of IUDs inserted in the Early Postpartum (EPP) period that are expelled at 6 months postpartum. This prospective, multi-site randomized trial will enroll approximately 404 women at three large academic hospitals in the United States.\n\nWomen will be recruited who are interested in receiving a levonorgestrel-IUD or a copper-IUD after delivery. Postpartum women who desire an IUD will be randomized to EPP IUD insertion (between 14-28 days PP) or interval postpartum IUD insertion (42-56 days PP) and the proportion of IUDs expelled will be compared between groups at 6 months postpartum. All women will be seen in clinic at 6-8 weeks and 6 months postpartum. Women randomized to EPP IUD placement will be seen at 2-3 weeks postpartum.\n\nProvider perspectives of EPP IUD placement will also be evaluated, as will whether these attitudes change after 6 to 9 months of providing early postpartum IUDs.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gave birth less than or equal to 10 days ago\n* Desires to use an IUD for Contraception (either copper or levonorgestrel)\n* Willing and able to sign an informed consent\n* Willing to comply with the study protocol\n* Age greater than or equal to 18 years\n* English or Spanish speaking\n\nExclusion Criteria:\n\n* Uterine anomaly or leiomyomata which would not allow placement of an IUD\n* Desire for repeat pregnancy in less than 6 months\n* Evidence of intrauterine infection (chorioamnionitis or postpartum endometritis) treated with antibiotics\n* Ruptured uterus at the time of delivery\n* Received a postpartum tubal ligation or immediate postpartum IUD or implant at delivery\n* Incarcerated women or women with significant cognitive impairment\n* 4th degree perineal laceration sustained at delivery\n* Any medical contraindication to IUD per the US Centers for Disease Control (CDC) Medical Eligibility Criteria\n* Suspicion for new pregnancy'}, 'identificationModule': {'nctId': 'NCT03462758', 'acronym': 'EPPIUD', 'briefTitle': 'Early vs. Interval Postpartum IUD Insertion', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Early vs. Interval Postpartum IUD Insertion: A Multi-site Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '172101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control Group', 'description': 'IUD placed 6-8 weeks postpartum (standard of care, interval placement)', 'interventionNames': ['Device: IUD']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)', 'interventionNames': ['Device: IUD']}], 'interventions': [{'name': 'IUD', 'type': 'DEVICE', 'otherNames': ['Mirena, Kyleena, Skyla, Liletta, ParaGard'], 'description': 'Postpartum IUD placement', 'armGroupLabels': ['Control Group', 'Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92134', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Naval Medical Center San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Sarah Averbach, MD, MAS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of New Mexico', 'class': 'OTHER'}, {'name': 'United States Naval Medical Center, San Diego', 'class': 'FED'}, {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, {'name': 'University of Chicago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sarah Averbach, MD MAS', 'investigatorAffiliation': 'University of California, San Diego'}}}}