Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT03754556
Status:
COMPLETED
Last Update Posted:
2020-12-04
First Post:
2018-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D014595', 'term': 'Uterine Perforation'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014597', 'term': 'Uterine Rupture'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007434', 'term': 'Intrauterine Devices'}], 'ancestors': [{'id': 'D003274', 'term': 'Contraceptive Devices, Female'}, {'id': 'D003273', 'term': 'Contraceptive Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'phone': '(+) 1-888-8422937', 'title': 'Therapeutic Area Head', 'organization': 'Bayer AG'}, 'certainAgreement': {'otherDetails': 'PI shall ensure that a written manuscript of any intended publication will be provided to BAYER at least 30 days prior to the intended submission or presentation in order to allow BAYER to review it. PI further agrees, upon written request from BAYER, not to submit such abstract or manuscript for publication or to make such presentation for the reasonably required time in order to allow for actions to be taken, which are necessary for BAYER to preserve rights to patents.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Retrospective analysis of data from 2001 to 2018', 'description': 'This research study used secondary data from which personal identifiers were removed. The outcomes of uterine perforation and IUD expulsion are reported in the study results. Based on current guidelines from ISPE and the EMA, non-interventional studies conducted using electronic claims and health care records do not require reporting of adverse events or reactions', 'eventGroups': [{'id': 'EG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Crude Incidence Rate of Uterine Perforation Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94817', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'Breastfeeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.25', 'groupId': 'OG000', 'lowerLimit': '3.89', 'upperLimit': '4.62'}]}]}, {'title': 'Not breastfeeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '2.11', 'upperLimit': '2.94'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)', 'unitOfMeasure': 'per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who were within 52 weeks postpartum and were or were not breastfeeding at the time of IUD insertion'}, {'type': 'PRIMARY', 'title': 'Cumulative Incidence of Uterine Perforation Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94817', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'Breastfeeding, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.60', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '0.67'}]}]}, {'title': 'Not breastfeeding, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000', 'lowerLimit': '0.29', 'upperLimit': '0.43'}]}]}, {'title': 'Breastfeeding, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.61', 'groupId': 'OG000', 'lowerLimit': '1.43', 'upperLimit': '1.81'}]}]}, {'title': 'Not breastfeeding, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.71', 'upperLimit': '1.08'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions', 'unitOfMeasure': 'number of outcomes/IUD insertions (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who were within 52 weeks postpartum and were or were not breastfeeding at the time of IUD insertion'}, {'type': 'PRIMARY', 'title': 'Adjusted Hazard Ratio (HR) for Breastfeeding Status and Uterine Perforation-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94817', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.37', 'groupId': 'OG000', 'lowerLimit': '1.12', 'upperLimit': '1.66'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Propensity score-adjusted hazard ratio to evaluate whether the risk of uterine perforation among women who were breastfeeding at the time of first observed IUD insertion differs from the risk of uterine perforation among women who were not breastfeeding at the time of first observed IUD insertion', 'unitOfMeasure': 'ajusted hazard ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who had given birth in the previous 52 weeks and had breastfeeding status "yes" or "no" were included in this analysis'}, {'type': 'PRIMARY', 'title': 'Crude Incidence Rate of Uterine Perforation Categorized by Postpartum Timing-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': '≤ 6 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20060', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.14', 'groupId': 'OG000', 'lowerLimit': '4.44', 'upperLimit': '5.92'}]}]}, {'title': '> 6 weeks and ≤ 14 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56047', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.77', 'groupId': 'OG000', 'lowerLimit': '3.42', 'upperLimit': '4.15'}]}]}, {'title': '> 14 weeks and ≤ 52 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21717', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.24', 'groupId': 'OG000', 'lowerLimit': '1.80', 'upperLimit': '2.75'}]}]}, {'title': '> 52 weeks postpartum or no delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228834', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.68', 'groupId': 'OG000', 'lowerLimit': '0.61', 'upperLimit': '0.76'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)', 'unitOfMeasure': 'per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with first observed IUD insertions at different postpartum timing or women without recorded delivery within the past 52 weeks'}, {'type': 'PRIMARY', 'title': 'Cumulative Incidence of Uterine Perforation Categorized by Postpartum Timing-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': '≤ 6 weeks postpartum (pp), 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20060', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '0.84'}]}]}, {'title': '> 6 weeks and ≤ 14 weeks pp, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56047', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000', 'lowerLimit': '0.48', 'upperLimit': '0.61'}]}]}, {'title': '> 14 weeks and ≤ 52 weeks pp, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21717', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '0.43'}]}]}, {'title': '> 52 weeks pp or no delivery, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228834', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.08'}]}]}, {'title': '≤ 6 weeks pp, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20060', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.89', 'groupId': 'OG000', 'lowerLimit': '1.55', 'upperLimit': '2.31'}]}]}, {'title': '> 6 weeks and ≤ 14 weeks pp, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56047', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.42', 'groupId': 'OG000', 'lowerLimit': '1.25', 'upperLimit': '1.61'}]}]}, {'title': '> 14 weeks and ≤ 52 weeks pp, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21717', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.74', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '0.97'}]}]}, {'title': '> 52 weeks pp or no delivery, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228834', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '0.34'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions', 'unitOfMeasure': 'number of outcomes/IUD insertions (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with first observed IUD insertions at different postpartum timing or women without recorded delivery within the past 52 weeks'}, {'type': 'PRIMARY', 'title': 'Adjusted Hazard Ratio (HR) for Postpartum Timing and Uterine Perforation-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': '≤ 6 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20060', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.29', 'groupId': 'OG000', 'lowerLimit': '4.50', 'upperLimit': '8.79'}]}]}, {'title': '> 6 weeks and ≤ 14 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56047', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.65', 'groupId': 'OG000', 'lowerLimit': '3.49', 'upperLimit': '6.20'}]}]}, {'title': '> 14 weeks and ≤ 52 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21717', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.94', 'groupId': 'OG000', 'lowerLimit': '2.16', 'upperLimit': '4.01'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Adjusted for propensity scores and breastfeeding status, to evaluate whether the risk of uterine perforation among women who had a first observed IUD insertion within different time periods postpartum differs from the risk of uterine perforation among women who had their first observed IUD insertion more than 52 weeks postpartum, including women without a recorded delivery within the past 52 weeks. Reference group: IUD insertion \\> 52 weeks postpartum', 'unitOfMeasure': 'ajusted hazard ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with first observed IUD insertions at different postpartum timing or women without recorded delivery within the past 52 weeks'}, {'type': 'PRIMARY', 'title': 'Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 14-week Cut Point and Uterine Perforation-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.44', 'groupId': 'OG000', 'lowerLimit': '2.70', 'upperLimit': '4.40'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Adjusted for propensity scores and breastfeeding status, to estimate the risk of uterine perforation among women who had a first observed IUD insertion early in the postpartum period (i.e., up to 14 weeks postpartum) versus those who had a first observed IUD insertion late in the postpartum period (i.e., more than 14 weeks postpartum, including women without recorded delivery within the past 52 weeks). Reference group: IUD insertion \\>14 weeks postpartum or with no recorded delivery', 'unitOfMeasure': 'adjusted hazard ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with first observed IUD insertions at different postpartum timing or women without recorded delivery within the past 52 weeks'}, {'type': 'PRIMARY', 'title': 'Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 36-week Cut Point and Uterine Perforation-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.36', 'groupId': 'OG000', 'lowerLimit': '3.45', 'upperLimit': '5.51'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Adjusted for propensity scores and breastfeeding status, to estimate the risk of uterine perforation among women who had a first observed IUD insertion ≤ 36 weeks postpartum versus women who had a first observed IUD insertion \\> 36 weeks postpartum, including women without recorded delivery within the past 52 weeks. Reference group: IUD insertion \\>36 weeks postpartum or with no recorded delivery', 'unitOfMeasure': 'adjusted hazard ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with first observed IUD insertions at different postpartum timing or women without recorded delivery within the past 52 weeks'}, {'type': 'PRIMARY', 'title': 'Adjusted Incidence Rate Ratio (IRR) for Uterine Perforation-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'Overall, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.72', 'groupId': 'OG000', 'lowerLimit': '3.74', 'upperLimit': '5.96'}]}]}, {'title': 'Overall, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.10', 'groupId': 'OG000', 'lowerLimit': '3.43', 'upperLimit': '4.90'}]}]}, {'title': 'Breastfeeding, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.11', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '2.47'}]}]}, {'title': 'Not breastfeeding, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.61', 'groupId': 'OG000', 'lowerLimit': '5.03', 'upperLimit': '8.76'}]}]}, {'title': 'Breastfeeding, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.47', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '3.07'}]}]}, {'title': 'Not breastfeeding, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.86', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '5.93'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Adjusted for propensity score, overall and stratified by breastfeeding status at the time of IUD insertion for ≤ 36 weeks postpartum at IUD insertion versus \\> 36 weeks postpartum or with no recorded delivery, at 1 year and 5 years of follow-up. Reference group: \\> 36 weeks or no delivery', 'unitOfMeasure': 'adjusted incidence rate ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with first observed IUD insertions at different postpartum timing or women without recorded delivery within the past 52 weeks'}, {'type': 'PRIMARY', 'title': 'Adjusted Incidence Rate Difference (IRD) for Uterine Perforation-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'Overall, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.75', 'groupId': 'OG000', 'lowerLimit': '3.05', 'upperLimit': '4.45'}]}]}, {'title': 'Overall, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.28', 'groupId': 'OG000', 'lowerLimit': '1.93', 'upperLimit': '2.63'}]}]}, {'title': 'Breastfeeding, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.63', 'groupId': 'OG000', 'lowerLimit': '-3.39', 'upperLimit': '4.64'}]}]}, {'title': 'Not breastfeeding, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.92', 'groupId': 'OG000', 'lowerLimit': '3.22', 'upperLimit': '4.63'}]}]}, {'title': 'Breastfeeding, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000', 'lowerLimit': '-0.46', 'upperLimit': '3.21'}]}]}, {'title': 'Not breastfeeding, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.33', 'groupId': 'OG000', 'lowerLimit': '1.97', 'upperLimit': '2.69'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Propensity score-adjusted incidence rate differences (per 1,000 person-years) for uterine perforation for women ≤ 36 weeks postpartum at IUD insertion compared with those who were \\> 36 weeks postpartum or with no recorded delivery, 1 year of follow-up and 5 years of follow-up, overall and stratified by breastfeeding status. Reference group: \\> 36 weeks or no delivery', 'unitOfMeasure': 'per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with first observed IUD insertions at different postpartum timing or women without recorded delivery within the past 52 weeks'}, {'type': 'PRIMARY', 'title': 'Crude Incidence Rate of Uterine Perforation Stratified by IUD Type-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322898', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'LNG-IUD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259534', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.64', 'groupId': 'OG000', 'lowerLimit': '1.53', 'upperLimit': '1.76'}]}]}, {'title': 'Copper IUD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63664', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.27', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '1.48'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)', 'unitOfMeasure': 'per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with either LNG-IUD (levonorgestrel-releasing intrauterine system) or copper IUD insertions'}, {'type': 'PRIMARY', 'title': 'Cumulative Incidence of Uterine Perforation Stratified by IUD Type-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322898', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'LNG-IUD, 1 year of follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259234', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '0.24'}]}]}, {'title': 'Copper IUD, 1 year of follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63664', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.13', 'upperLimit': '0.20'}]}]}, {'title': 'LNG-IUD, 5 years of follow up', 'denoms': [{'units': 'Participants', 'counts': 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'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with either LNG-IUD (levonorgestrel-releasing intrauterine system) or copper IUD insertions'}, {'type': 'PRIMARY', 'title': 'Crude Incidence Rate of Uterine Perforation Stratified by Menorrhagia Status-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32552', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.77', 'upperLimit': '1.28'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294106', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.63', 'groupId': 'OG000', 'lowerLimit': '1.53', 'upperLimit': '1.74'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)', 'unitOfMeasure': 'per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with menorrhagia (heavy menstrual bleeding) status (yes/no) in the 12 months before IUD insertion'}, {'type': 'PRIMARY', 'title': 'Cumulative Incidence of Uterine Perforation Stratified by Menorrhagia Status-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 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menorrhagia (heavy menstrual bleeding) status (yes/no) in the 12 months before IUD insertion'}, {'type': 'PRIMARY', 'title': 'Effect Modification of Breastfeeding Status on Postpartum Timing for Uterine Perforation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94817', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': '≤ 14 weeks, breastfeeding yes vs.no', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94817', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.28', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '1.61'}]}]}, {'title': '> 14 to ≤ 52 weeks, breastfeeding yes vs.no', 'denoms': [{'units': 'Participants', 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'populationDescription': 'Women who had given birth in the previous 52 weeks and had breastfeeding status "yes" or "no" were included in this analysis'}, {'type': 'PRIMARY', 'title': 'Effect Modification of IUD Type on Postpartum Timing for Uterine Perforation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322898', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'LNG-IUD, ≤ 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.78', 'groupId': 'OG000', 'lowerLimit': '4.74', 'upperLimit': '9.70'}]}]}, {'title': 'LNG-IUD, > 6 to ≤ 14 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42760', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.11', 'groupId': 'OG000', 'lowerLimit': '3.75', 'upperLimit': '6.95'}]}]}, {'title': 'LNG-IUD, > 14 to ≤ 52 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000', 'lowerLimit': '2.21', 'upperLimit': '4.42'}]}]}, {'title': 'Copper IUD, ≤ 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4228', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.30', 'groupId': 'OG000', 'lowerLimit': '2.38', 'upperLimit': '7.75'}]}]}, {'title': 'Copper IUD, > 6 to ≤ 14 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12934', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.61', 'groupId': 'OG000', 'lowerLimit': '1.56', 'upperLimit': '4.36'}]}]}, {'title': 'Copper IUD, > 14 to ≤ 52 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5379', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.01', 'groupId': 'OG000', 'lowerLimit': '1.05', 'upperLimit': '3.85'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Adjusted for propensity score and breastfeeding status, to evaluate the extent to which type of IUD (LNG-IUD vs. copper IUD) modified the association between uterine perforation and postpartum timing of IUD insertion for women with IUD insertion at different time periods postpartum (i.e., ≤ 6 weeks, \\> 6 and ≤ 14 weeks, \\> 14 and ≤ 52 weeks) versus IUD insertion more than 52 weeks postpartum, including no recorded delivery within the past 52 weeks, at the time of the first observed IUD insertion. 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[{'value': '64186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.23', 'groupId': 'OG000', 'lowerLimit': '9.68', 'upperLimit': '10.81'}]}]}, {'title': 'Not breastfeeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.58', 'groupId': 'OG000', 'lowerLimit': '13.62', 'upperLimit': '15.59'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)', 'unitOfMeasure': 'per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who were within 52 weeks postpartum and were or were not breastfeeding at the time of IUD insertion'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of IUD Expulsion Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94817', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'Breastfeeding, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.55', 'groupId': 'OG000', 'lowerLimit': '1.44', 'upperLimit': '1.65'}]}]}, {'title': 'Not breastfeeding, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.45', 'groupId': 'OG000', 'lowerLimit': '2.27', 'upperLimit': '2.65'}]}]}, {'title': 'Breastfeeding, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.49', 'groupId': 'OG000', 'lowerLimit': '3.25', 'upperLimit': '3.73'}]}]}, {'title': 'Not breastfeeding, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.57', 'groupId': 'OG000', 'lowerLimit': '4.22', 'upperLimit': '4.95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions', 'unitOfMeasure': 'number of outcomes/IUD insertions (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who were within 52 weeks postpartum and were or were not breastfeeding at the time of IUD insertion'}, {'type': 'SECONDARY', 'title': 'Adjusted Hazard Ratio (HR) for Breastfeeding Status and IUD Expulsion-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94817', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '0.78'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Propensity score-adjusted to evaluate whether the risk of IUD expulsion among women who were breastfeeding at the time of first observed IUD insertion differs from the risk of IUD expulsion among women who were not breastfeeding at the time of first observed IUD insertion', 'unitOfMeasure': 'adjusted hazard ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who had given birth in the previous 52 weeks and had breastfeeding status "yes" or "no" were included in this analysis'}, {'type': 'SECONDARY', 'title': 'Crude Incidence Rate of IUD Expulsion Categorized by Postpartum Timing-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': '≤ 3 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2788', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.54', 'groupId': 'OG000', 'lowerLimit': '40.54', 'upperLimit': '53.18'}]}]}, {'title': '4 days to ≤ 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17272', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.88', 'groupId': 'OG000', 'lowerLimit': '9.78', 'upperLimit': '12.08'}]}]}, {'title': '≤ 6 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20060', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.33', 'groupId': 'OG000', 'lowerLimit': '14.10', 'upperLimit': '16.65'}]}]}, {'title': '> 6 weeks and ≤ 14 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56047', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.29', 'groupId': 'OG000', 'lowerLimit': '8.73', 'upperLimit': '9.87'}]}]}, {'title': '> 14 weeks and ≤ 52 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21717', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.36', 'groupId': 'OG000', 'lowerLimit': '13.22', 'upperLimit': '15.57'}]}]}, {'title': '> 52 weeks postpartum or no delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228834', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.93', 'groupId': 'OG000', 'lowerLimit': '14.57', 'upperLimit': '15.29'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)', 'unitOfMeasure': 'per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with first observed IUD insertions at different postpartum timing or women without recorded delivery within the past 52 weeks'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of IUD Expulsion Categorized by Postpartum Timing-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': '≤ 3 days, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2788', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.84', 'groupId': 'OG000', 'lowerLimit': '6.83', 'upperLimit': '9.00'}]}]}, {'title': '4 days to ≤ 6 weeks, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17272', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.87', 'groupId': 'OG000', 'lowerLimit': '3.40', 'upperLimit': '4.42'}]}]}, {'title': '≤ 6 weeks postpartum (pp), 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20060', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.46', 'groupId': 'OG000', 'lowerLimit': '2.24', 'upperLimit': '2.71'}]}]}, {'title': '> 6 weeks and ≤ 14 weeks pp, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56047', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.40', 'groupId': 'OG000', 'lowerLimit': '1.30', 'upperLimit': '1.51'}]}]}, {'title': '> 14 weeks and ≤ 52 weeks pp, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21717', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.33', 'groupId': 'OG000', 'lowerLimit': '2.12', 'upperLimit': '2.56'}]}]}, {'title': '> 52 weeks pp or no delivery, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228834', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.49', 'groupId': 'OG000', 'lowerLimit': '2.42', 'upperLimit': '2.56'}]}]}, {'title': '≤ 3 days, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2788', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.73', 'groupId': 'OG000', 'lowerLimit': '9.12', 'upperLimit': '12.61'}]}]}, {'title': '4 days to ≤ 6 weeks, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17272', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.61', 'groupId': 'OG000', 'lowerLimit': '1.42', 'upperLimit': '1.84'}]}]}, {'title': '≤ 6 weeks pp, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20060', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.81', 'groupId': 'OG000', 'lowerLimit': '4.33', 'upperLimit': '5.33'}]}]}, {'title': '> 6 weeks and ≤ 14 weeks pp, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56047', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.18', 'groupId': 'OG000', 'lowerLimit': '2.95', 'upperLimit': '3.42'}]}]}, {'title': '> 14 weeks and ≤ 52 weeks pp, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21717', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.55', 'groupId': 'OG000', 'lowerLimit': '4.12', 'upperLimit': '5.02'}]}]}, {'title': '> 52 weeks pp or no delivery, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228834', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.88', 'groupId': 'OG000', 'lowerLimit': '4.74', 'upperLimit': '5.02'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions', 'unitOfMeasure': 'number of outcomes/IUD insertions (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with first observed IUD insertions at different postpartum timing or women without recorded delivery within the past 52 weeks'}, {'type': 'SECONDARY', 'title': 'Adjusted Hazard Ratio (HR) for Postpartum Timing and IUD Expulsion-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'Within 49 days, ≤ 6 weeks postpartum (pp)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20060', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.93', 'groupId': 'OG000', 'lowerLimit': '1.59', 'upperLimit': '2.35'}]}]}, {'title': 'Within 49 days, > 6 weeks and ≤ 14 weeks pp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56047', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '1.05'}]}]}, {'title': 'Within 49 days, > 14 weeks and ≤ 52 weeks pp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21717', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000', 'lowerLimit': '1.14', 'upperLimit': '1.68'}]}]}, {'title': 'After 49 days, ≤ 6 weeks pp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20060', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.32', 'groupId': 'OG000', 'lowerLimit': '1.15', 'upperLimit': '1.53'}]}]}, {'title': 'After 49 days, > 6 weeks and ≤ 14 weeks pp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56047', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.92', 'upperLimit': '1.16'}]}]}, {'title': 'After 49 days, > 14 weeks and ≤ 52 weeks pp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21717', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.39', 'groupId': 'OG000', 'lowerLimit': '1.23', 'upperLimit': '1.57'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Adjusted for propensity score and breastfeeding status, to evaluate whether the risk of IUD expulsion before and after 49 days of insertion among women who had a first observed IUD insertion within different time periods postpartum differs from the risk of IUD expulsion among women who had their first observed IUD insertion more than 52 weeks postpartum, including women without a recorded delivery within the past 52 weeks Reference group: IUD insertion \\> 52 weeks postpartum', 'unitOfMeasure': 'adjusted hazard ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with first observed IUD insertions at different postpartum timing or women without recorded delivery within the past 52 weeks'}, {'type': 'SECONDARY', 'title': 'Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 14-week Cut Point and IUD Expulsion-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '0.94'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Adjusted for propensity scores, to estimate the risk of IUD expulsion among women who had a first observed IUD insertion early in the postpartum period (i.e., up to 14 weeks postpartum) versus those who had a first observed IUD insertion late in the postpartum period (i.e., more than 14 weeks postpartum, including women without recorded delivery within the past 52 weeks). Reference group: IUD insertion \\>14 weeks postpartum or with no recorded delivery', 'unitOfMeasure': 'adjusted hazard ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with first observed IUD insertions at different postpartum timing or women without recorded delivery within the past 52 weeks'}, {'type': 'SECONDARY', 'title': 'Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 36-week Cut Point and IUD Expulsion-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.95', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '1.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Adjusted for propensity scores, to estimate the risk of IUD expulsion among women who had a first observed IUD insertion ≤ 36 weeks postpartum versus women who had a first observed IUD insertion \\> 36 weeks postpartum, including women without recorded delivery within the past 52 weeks. Reference group: IUD insertion \\>36 weeks postpartum or with no recorded delivery', 'unitOfMeasure': 'adjusted hazard ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with first observed IUD insertions at different postpartum timing or women without recorded delivery within the past 52 weeks'}, {'type': 'SECONDARY', 'title': 'Adjusted Incidence Rate Ratio (IRR) for IUD Expulsion-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'Overall, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.21', 'groupId': 'OG000', 'lowerLimit': '1.12', 'upperLimit': '1.30'}]}]}, {'title': 'Overall, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.20', 'groupId': 'OG000', 'lowerLimit': '1.13', 'upperLimit': '1.28'}]}]}, {'title': 'Breastfeeding, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.60', 'groupId': 'OG000', 'lowerLimit': '0.44', 'upperLimit': '0.85'}]}]}, {'title': 'Not breastfeeding, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.25', 'groupId': 'OG000', 'lowerLimit': '1.16', 'upperLimit': '1.35'}]}]}, {'title': 'Breastfeeding, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '1.10'}]}]}, {'title': 'Not breastfeeding, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.23', 'groupId': 'OG000', 'lowerLimit': '1.15', 'upperLimit': '1.31'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Overall and stratified by breastfeeding status at the time of IUD insertion for IUD expulsion for ≤ 36 weeks postpartum at IUD insertion versus \\> 36 weeks postpartum or with no recorded delivery, at 1 year and 5 years of follow-up Reference group: \\> 36 weeks or no delivery', 'unitOfMeasure': 'adjusted incidence rate ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with first observed IUD insertions at different postpartum timing or women without recorded delivery within the past 52 weeks'}, {'type': 'SECONDARY', 'title': 'Adjusted Incidence Rate Difference (IRD) for IUD Expulsion-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'Overall, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.28', 'groupId': 'OG000', 'lowerLimit': '2.50', 'upperLimit': '6.06'}]}]}, {'title': 'Overall, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.37', 'groupId': 'OG000', 'lowerLimit': '1.53', 'upperLimit': '3.22'}]}]}, {'title': 'Breastfeeding, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.79', 'groupId': 'OG000', 'lowerLimit': '-19.43', 'upperLimit': '-2.15'}]}]}, {'title': 'Breastfeeding, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.62', 'groupId': 'OG000', 'lowerLimit': '-6.51', 'upperLimit': '1.26'}]}]}, {'title': 'Not breastfeeding, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.11', 'groupId': 'OG000', 'lowerLimit': '3.27', 'upperLimit': '6.94'}]}]}, {'title': 'Not breastfeeding, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.65', 'groupId': 'OG000', 'lowerLimit': '1.78', 'upperLimit': '3.53'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Adjusted incidence rate differences (per 1,000 person-years) for IUD expulsion for women ≤ 36 weeks postpartum at IUD insertion compared with those who were \\> 36 weeks postpartum or with no recorded delivery, 1 year of follow-up and 5 years of follow-up, overall and stratified by breastfeeding status Reference group: \\> 36 weeks or no delivery', 'unitOfMeasure': 'per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with first observed IUD insertions at different postpartum timing or women without recorded delivery within the past 52 weeks'}, {'type': 'SECONDARY', 'title': 'Crude Incidence Rate of IUD Expulsion Stratified by IUD Type-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322898', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'LNG-IUD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259534', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.95', 'groupId': 'OG000', 'lowerLimit': '13.63', 'upperLimit': '14.28'}]}]}, {'title': 'Copper IUD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63664', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.08', 'groupId': 'OG000', 'lowerLimit': '13.44', 'upperLimit': '14.75'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)', 'unitOfMeasure': 'per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with either LNG-IUD (levonorgestrel-releasing intrauterine system) or copper IUD insertions'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of IUD Expulsion Stratified by IUD Type-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322898', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'LNG-IUD, 1 year of follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259234', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.30', 'groupId': 'OG000', 'lowerLimit': '2.24', 'upperLimit': '2.36'}]}]}, {'title': 'Copper IUD, 1 year of follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63664', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.30', 'groupId': 'OG000', 'lowerLimit': '2.18', 'upperLimit': '2.44'}]}]}, {'title': 'LNG-IUD, 5 years of follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259234', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.52', 'groupId': 'OG000', 'lowerLimit': '4.40', 'upperLimit': '4.65'}]}]}, {'title': 'Copper IUD, 5 years of follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63664', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.82', 'groupId': 'OG000', 'lowerLimit': '4.56', 'upperLimit': '5.10'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions', 'unitOfMeasure': 'number of outcomes/IUD insertions (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with either LNG-IUD (levonorgestrel-releasing intrauterine system) or copper IUD insertions'}, {'type': 'SECONDARY', 'title': 'Adjusted Hazard Ratio (HR) for IUD Type and IUD Expulsion-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322898', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '0.65', 'upperLimit': '0.73'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Propensity score adjusted to evaluate whether the risk of IUD expulsion among women with LNG-releasing IUD at the time of first observed IUD insertion differs from the risk of IUD expulsion among women with copper IUD at the time of first observed IUD insertion', 'unitOfMeasure': 'adjusted hazard ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with either LNG-IUD (levonorgestrel-releasing intrauterine system) or copper IUD insertions'}, {'type': 'SECONDARY', 'title': 'Crude Incidence Rate of IUD Expulsion Stratified by Menorrhagia Status-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32552', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.56', 'groupId': 'OG000', 'lowerLimit': '38.03', 'upperLimit': '41.13'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294106', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.10', 'groupId': 'OG000', 'lowerLimit': '10.83', 'upperLimit': '11.38'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)', 'unitOfMeasure': 'per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with menorrhagia (heavy menstrual bleeding) status (yes/no) available in the 12 months before IUD insertion'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of IUD Expulsion Stratified by Menorrhagia Status-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'Yes, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32552', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.89', 'groupId': 'OG000', 'lowerLimit': '6.60', 'upperLimit': '7.20'}]}]}, {'title': 'No, 1 year of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294106', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.78', 'groupId': 'OG000', 'lowerLimit': '1.73', 'upperLimit': '1.84'}]}]}, {'title': 'Yes, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32552', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.89', 'groupId': 'OG000', 'lowerLimit': '11.40', 'upperLimit': '12.41'}]}]}, {'title': 'No, 5 years of follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294106', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.72', 'groupId': 'OG000', 'lowerLimit': '3.61', 'upperLimit': '3.83'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions', 'unitOfMeasure': 'number of outcomes/IUD insertions (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with menorrhagia (heavy menstrual bleeding) status (yes/no) available in the 12 months before IUD insertion'}, {'type': 'SECONDARY', 'title': 'Adjusted Hazard Ratio (HR) for Menorrhagia Status and IUD Expulsion-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.79', 'groupId': 'OG000', 'lowerLimit': '2.62', 'upperLimit': '2.98'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Propensity score adjusted to evaluate whether the risk of IUD expulsion among women using an IUD who have at least one diagnosis code indicating menorrhagia in the 12 months before IUD insertion differs from the risk of IUD expulsion among women who do not have this indication', 'unitOfMeasure': 'adjusted hazard ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with menorrhagia (heavy menstrual bleeding) status (yes/no) available in the 12 months before IUD insertion'}, {'type': 'SECONDARY', 'title': 'Effect Modification of IUD Type on Breastfeeding Status for IUD Expulsion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94205', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'LNG-IUD, breastfeeding yes vs.no', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72201', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '0.80'}]}]}, {'title': 'Copper IUD, breastfeeding yes vs.no', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22004', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.66', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '0.80'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Propensity score-adjusted hazard ratios to evaluate the extent to which type of IUD (LNG-IUD vs. copper IUD) modified the association between IUD expulsion and breastfeeding among women who were and were not breastfeeding at the time of first observed IUD insertion', 'unitOfMeasure': 'adjusted hazard ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who had given birth in the previous 52 weeks and had breastfeeding status "yes" or "no" were included in this analysis'}, {'type': 'SECONDARY', 'title': 'Effect Modification of IUD Type on Postpartum Timing for IUD Expulsion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322898', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'LNG-IUD, ≤ 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.59', 'groupId': 'OG000', 'lowerLimit': '1.38', 'upperLimit': '1.82'}]}]}, {'title': 'LNG-IUD, > 6 to ≤ 14 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42760', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '1.14'}]}]}, {'title': 'LNG-IUD, > 14 to ≤ 52 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.40', 'groupId': 'OG000', 'lowerLimit': '1.23', 'upperLimit': '1.58'}]}]}, {'title': 'Copper IUD, ≤ 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4228', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.23', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '1.53'}]}]}, {'title': 'Copper IUD, > 6 to ≤ 14 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12934', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '1.13'}]}]}, {'title': 'Copper IUD, > 14 to ≤ 52 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5379', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.35', 'groupId': 'OG000', 'lowerLimit': '1.13', 'upperLimit': '1.63'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'Adjusted for propensity score and breastfeeding status, to evaluate the extent to which type of IUD (LNG-IUD vs. copper IUD) modified the association between IUD expulsion and postpartum timing of IUD insertion for women with IUD insertion at different time periods postpartum (i.e., ≤ 6 weeks, \\> 6 and ≤ 14 weeks, \\> 14 and ≤ 52 weeks) versus IUD insertion more than 52 weeks postpartum, including no recorded delivery within the past 52 weeks, at the time of the first observed IUD insertion. Reference group: LNG-IUD or Copper IUD, \\> 52 weeks or no delivery', 'unitOfMeasure': 'adjusted hazard ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with either LNG-IUD (levonorgestrel-releasing intrauterine system) or copper IUD insertions'}, {'type': 'SECONDARY', 'title': 'Number of Indicators of a Potentially Difficult Insertion, Overall, by Breastfeeding Status, and by Postpartum Timing of IUD Insertion-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29777', 'groupId': 'OG000'}]}]}, {'title': 'Breastfeeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1686', 'groupId': 'OG000'}]}]}, {'title': 'Not breastfeeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1077', 'groupId': 'OG000'}]}]}, {'title': '≤ 6 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20060', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '573', 'groupId': 'OG000'}]}]}, {'title': '> 6 weeks and ≤ 14 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56047', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1261', 'groupId': 'OG000'}]}]}, {'title': '> 14 weeks and ≤ 52 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21717', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1146', 'groupId': 'OG000'}]}]}, {'title': '> 52 weeks postpartum or no delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228834', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26797', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'To describe the prevalence of indicators of a difficult IUD insertion (e.g., need for cervical dilation, ultrasound guidance, paracervical block, clinician not indicating difficulty, use of misoprostol among all users)', 'unitOfMeasure': 'indicators', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with first observed IUD insertions'}, {'type': 'SECONDARY', 'title': 'Number of Indicators of a Potentially Difficult Insertion, Overall, by IUD Type and by Menorrhagia Status-first Observed IUD Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29777', 'groupId': 'OG000'}]}]}, {'title': 'LNG-IUD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259234', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24666', 'groupId': 'OG000'}]}]}, {'title': 'Copper IUD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63664', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4648', 'groupId': 'OG000'}]}]}, {'title': 'With menorrhagia in the past year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32552', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3754', 'groupId': 'OG000'}]}]}, {'title': 'Without menorrhagia in the past year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294106', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26023', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 11 years', 'description': 'To describe the prevalence of indicators of a difficult IUD insertion (e.g., need for cervical dilation, ultrasound guidance, paracervical block, clinician not indicating difficulty, use of misoprostol among all users)', 'unitOfMeasure': 'indicators', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with first observed IUD insertions'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '326658'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '326658'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was a retrospective cohort study, using the data from three health care systems: Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and one research institute with access to a health information exchange, Regenstrief Institute (RI)', 'preAssignmentDetails': 'Between 01 January 2001 and 30 April 2018, 326658 participants were identified: 322898 participants with intrauterine device (IUD) type available and 94817 participants with breastfeeding status available (and IUD insertion within 12 months postpartum)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '326658', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Women With IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '≤ 28 years', 'measurements': [{'value': '119469', 'groupId': 'BG000'}]}, {'title': '> 28 to ≤ 36 years', 'measurements': [{'value': '107871', 'groupId': 'BG000'}]}, {'title': '> 36 to ≤ 50 years', 'measurements': [{'value': '99318', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '326658', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian/Pacific Islander', 'measurements': [{'value': '38911', 'groupId': 'BG000'}]}, {'title': 'Hispanic black', 'measurements': [{'value': '696', 'groupId': 'BG000'}]}, {'title': 'Hispanic white', 'measurements': [{'value': '42501', 'groupId': 'BG000'}]}, {'title': 'Hispanic other', 'measurements': [{'value': '56180', 'groupId': 'BG000'}]}, {'title': 'Non-Hispanic black', 'measurements': [{'value': '28323', 'groupId': 'BG000'}]}, {'title': 'Non-Hispanic white', 'measurements': [{'value': '137102', 'groupId': 'BG000'}]}, {'title': 'Other or multiple', 'measurements': [{'value': '16357', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '6588', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Breastfeeding status', 'classes': [{'categories': [{'title': 'Yes (for those ≤ 52 weeks postpartum)', 'measurements': [{'value': '64186', 'groupId': 'BG000'}]}, {'title': 'No (for those ≤ 52 weeks postpartum)', 'measurements': [{'value': '30631', 'groupId': 'BG000'}]}, {'title': 'Undetermined (for those ≤ 52 weeks postpartum)', 'measurements': [{'value': '3007', 'groupId': 'BG000'}]}, {'title': 'No delivery in the past year', 'measurements': [{'value': '228834', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Postpartum time of IUD insertion', 'classes': [{'categories': [{'title': '0 to 3 days', 'measurements': [{'value': '2788', 'groupId': 'BG000'}]}, {'title': '4 days to ≤ 6 weeks', 'measurements': [{'value': '17272', 'groupId': 'BG000'}]}, {'title': '> 6 to ≤ 14 weeks', 'measurements': [{'value': '56047', 'groupId': 'BG000'}]}, {'title': '> 14 to ≤ 52 weeks', 'measurements': [{'value': '21717', 'groupId': 'BG000'}]}, {'title': '> 52 weeks or no delivery', 'measurements': [{'value': '228834', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Menorrhagia', 'classes': [{'categories': [{'title': '≤ 12 months before insertion', 'measurements': [{'value': '32552', 'groupId': 'BG000'}]}, {'title': '> 12 months or no diagnosis', 'measurements': [{'value': '294106', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'IUD type', 'classes': [{'categories': [{'title': 'Levonorgestrel (LNG)-IUD', 'measurements': [{'value': '259234', 'groupId': 'BG000'}]}, {'title': 'Copper IUD', 'measurements': [{'value': '63664', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '3760', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-29', 'size': 9919688, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-10T21:07', 'hasProtocol': True}, {'date': '2018-10-24', 'size': 9984824, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-11-10T21:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 326658}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2018-11-23', 'resultsFirstSubmitDate': '2020-11-10', 'studyFirstSubmitQcDate': '2018-11-23', 'lastUpdatePostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-10', 'studyFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Crude Incidence Rate of Uterine Perforation Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)'}, {'measure': 'Cumulative Incidence of Uterine Perforation Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions'}, {'measure': 'Adjusted Hazard Ratio (HR) for Breastfeeding Status and Uterine Perforation-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Propensity score-adjusted hazard ratio to evaluate whether the risk of uterine perforation among women who were breastfeeding at the time of first observed IUD insertion differs from the risk of uterine perforation among women who were not breastfeeding at the time of first observed IUD insertion'}, {'measure': 'Crude Incidence Rate of Uterine Perforation Categorized by Postpartum Timing-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)'}, {'measure': 'Cumulative Incidence of Uterine Perforation Categorized by Postpartum Timing-first Observed IUD Insertions', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions'}, {'measure': 'Adjusted Hazard Ratio (HR) for Postpartum Timing and Uterine Perforation-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Adjusted for propensity scores and breastfeeding status, to evaluate whether the risk of uterine perforation among women who had a first observed IUD insertion within different time periods postpartum differs from the risk of uterine perforation among women who had their first observed IUD insertion more than 52 weeks postpartum, including women without a recorded delivery within the past 52 weeks. Reference group: IUD insertion \\> 52 weeks postpartum'}, {'measure': 'Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 14-week Cut Point and Uterine Perforation-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Adjusted for propensity scores and breastfeeding status, to estimate the risk of uterine perforation among women who had a first observed IUD insertion early in the postpartum period (i.e., up to 14 weeks postpartum) versus those who had a first observed IUD insertion late in the postpartum period (i.e., more than 14 weeks postpartum, including women without recorded delivery within the past 52 weeks). Reference group: IUD insertion \\>14 weeks postpartum or with no recorded delivery'}, {'measure': 'Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 36-week Cut Point and Uterine Perforation-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Adjusted for propensity scores and breastfeeding status, to estimate the risk of uterine perforation among women who had a first observed IUD insertion ≤ 36 weeks postpartum versus women who had a first observed IUD insertion \\> 36 weeks postpartum, including women without recorded delivery within the past 52 weeks. Reference group: IUD insertion \\>36 weeks postpartum or with no recorded delivery'}, {'measure': 'Adjusted Incidence Rate Ratio (IRR) for Uterine Perforation-first Observed IUD Insertions', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Adjusted for propensity score, overall and stratified by breastfeeding status at the time of IUD insertion for ≤ 36 weeks postpartum at IUD insertion versus \\> 36 weeks postpartum or with no recorded delivery, at 1 year and 5 years of follow-up. Reference group: \\> 36 weeks or no delivery'}, {'measure': 'Adjusted Incidence Rate Difference (IRD) for Uterine Perforation-first Observed IUD Insertions', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Propensity score-adjusted incidence rate differences (per 1,000 person-years) for uterine perforation for women ≤ 36 weeks postpartum at IUD insertion compared with those who were \\> 36 weeks postpartum or with no recorded delivery, 1 year of follow-up and 5 years of follow-up, overall and stratified by breastfeeding status. Reference group: \\> 36 weeks or no delivery'}, {'measure': 'Crude Incidence Rate of Uterine Perforation Stratified by IUD Type-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)'}, {'measure': 'Cumulative Incidence of Uterine Perforation Stratified by IUD Type-first Observed IUD Insertions', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions'}, {'measure': 'Adjusted Hazard Ratio (HR) for IUD Type and Uterine Perforation-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Propensity score-adjusted hazard ratio to evaluate whether the risk of uterine perforation among women with LNG-releasing IUD at the time of first observed IUD insertion differs from the risk of uterine perforation among women with copper IUD at the time of first observed IUD insertion'}, {'measure': 'Crude Incidence Rate of Uterine Perforation Stratified by Menorrhagia Status-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)'}, {'measure': 'Cumulative Incidence of Uterine Perforation Stratified by Menorrhagia Status-first Observed IUD Insertions', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions'}, {'measure': 'Adjusted Hazard Ratio (HR) for Menorrhagia Status and Uterine Perforation-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Propensity score-adjusted hazard ratio to evaluate whether the risk of uterine perforation among women using an IUD who have at least one diagnosis code indicating menorrhagia in the 12 months before IUD insertion differs from the risk of uterine perforation among women who do not have this indication'}, {'measure': 'Effect Modification of Breastfeeding Status on Postpartum Timing for Uterine Perforation', 'timeFrame': 'Up to 11 years', 'description': 'Propensity score-adjusted hazard ratios to evaluate the extent to which breastfeeding status (yes vs. no) modified the association of uterine perforation for women with IUD insertion at different time periods postpartum (i.e., IUD insertion ≤ 14 weeks versus IUD insertion \\> 14 weeks postpartum) among women with a recorded delivery within the past 52 weeks at the time of the first observed IUD insertion'}, {'measure': 'Effect Modification of IUD Type on Breastfeeding Status for Uterine Perforation', 'timeFrame': 'Up to 11 years', 'description': 'Propensity score-adjusted hazard ratios to evaluate the extent to which type of IUD (LNG-IUD vs. copper IUD) modified the association between uterine perforation and breastfeeding among women who were and were not breastfeeding at the time of first observed IUD insertion'}, {'measure': 'Effect Modification of IUD Type on Postpartum Timing for Uterine Perforation', 'timeFrame': 'Up to 11 years', 'description': 'Adjusted for propensity score and breastfeeding status, to evaluate the extent to which type of IUD (LNG-IUD vs. copper IUD) modified the association between uterine perforation and postpartum timing of IUD insertion for women with IUD insertion at different time periods postpartum (i.e., ≤ 6 weeks, \\> 6 and ≤ 14 weeks, \\> 14 and ≤ 52 weeks) versus IUD insertion more than 52 weeks postpartum, including no recorded delivery within the past 52 weeks, at the time of the first observed IUD insertion. Reference group: LNG-IUD or Copper IUD, \\> 52 weeks or no delivery'}], 'secondaryOutcomes': [{'measure': 'Crude Incidence Rate of IUD Expulsion Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)'}, {'measure': 'Cumulative Incidence of IUD Expulsion Stratified by Breastfeeding Status Among Women Within 52 Weeks Postpartum-first Observed IUD Insertions', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions'}, {'measure': 'Adjusted Hazard Ratio (HR) for Breastfeeding Status and IUD Expulsion-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Propensity score-adjusted to evaluate whether the risk of IUD expulsion among women who were breastfeeding at the time of first observed IUD insertion differs from the risk of IUD expulsion among women who were not breastfeeding at the time of first observed IUD insertion'}, {'measure': 'Crude Incidence Rate of IUD Expulsion Categorized by Postpartum Timing-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)'}, {'measure': 'Cumulative Incidence of IUD Expulsion Categorized by Postpartum Timing-first Observed IUD Insertions', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions'}, {'measure': 'Adjusted Hazard Ratio (HR) for Postpartum Timing and IUD Expulsion-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Adjusted for propensity score and breastfeeding status, to evaluate whether the risk of IUD expulsion before and after 49 days of insertion among women who had a first observed IUD insertion within different time periods postpartum differs from the risk of IUD expulsion among women who had their first observed IUD insertion more than 52 weeks postpartum, including women without a recorded delivery within the past 52 weeks Reference group: IUD insertion \\> 52 weeks postpartum'}, {'measure': 'Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 14-week Cut Point and IUD Expulsion-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Adjusted for propensity scores, to estimate the risk of IUD expulsion among women who had a first observed IUD insertion early in the postpartum period (i.e., up to 14 weeks postpartum) versus those who had a first observed IUD insertion late in the postpartum period (i.e., more than 14 weeks postpartum, including women without recorded delivery within the past 52 weeks). Reference group: IUD insertion \\>14 weeks postpartum or with no recorded delivery'}, {'measure': 'Adjusted Hazard Ratio (HR) for Postpartum Timing Risk 36-week Cut Point and IUD Expulsion-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Adjusted for propensity scores, to estimate the risk of IUD expulsion among women who had a first observed IUD insertion ≤ 36 weeks postpartum versus women who had a first observed IUD insertion \\> 36 weeks postpartum, including women without recorded delivery within the past 52 weeks. Reference group: IUD insertion \\>36 weeks postpartum or with no recorded delivery'}, {'measure': 'Adjusted Incidence Rate Ratio (IRR) for IUD Expulsion-first Observed IUD Insertions', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Overall and stratified by breastfeeding status at the time of IUD insertion for IUD expulsion for ≤ 36 weeks postpartum at IUD insertion versus \\> 36 weeks postpartum or with no recorded delivery, at 1 year and 5 years of follow-up Reference group: \\> 36 weeks or no delivery'}, {'measure': 'Adjusted Incidence Rate Difference (IRD) for IUD Expulsion-first Observed IUD Insertions', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Adjusted incidence rate differences (per 1,000 person-years) for IUD expulsion for women ≤ 36 weeks postpartum at IUD insertion compared with those who were \\> 36 weeks postpartum or with no recorded delivery, 1 year of follow-up and 5 years of follow-up, overall and stratified by breastfeeding status Reference group: \\> 36 weeks or no delivery'}, {'measure': 'Crude Incidence Rate of IUD Expulsion Stratified by IUD Type-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)'}, {'measure': 'Cumulative Incidence of IUD Expulsion Stratified by IUD Type-first Observed IUD Insertions', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions'}, {'measure': 'Adjusted Hazard Ratio (HR) for IUD Type and IUD Expulsion-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Propensity score adjusted to evaluate whether the risk of IUD expulsion among women with LNG-releasing IUD at the time of first observed IUD insertion differs from the risk of IUD expulsion among women with copper IUD at the time of first observed IUD insertion'}, {'measure': 'Crude Incidence Rate of IUD Expulsion Stratified by Menorrhagia Status-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Crude incidence rate was calculated as the number of outcomes occurring during the person-time at risk divided by the total person-time at risk (in person-years)'}, {'measure': 'Cumulative Incidence of IUD Expulsion Stratified by Menorrhagia Status-first Observed IUD Insertions', 'timeFrame': 'At 1 year and 5 years of follow-up', 'description': 'Crude estimates of the cumulative incidence, defined as number of outcomes occurring up to a time point out of the number of IUD insertions'}, {'measure': 'Adjusted Hazard Ratio (HR) for Menorrhagia Status and IUD Expulsion-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'Propensity score adjusted to evaluate whether the risk of IUD expulsion among women using an IUD who have at least one diagnosis code indicating menorrhagia in the 12 months before IUD insertion differs from the risk of IUD expulsion among women who do not have this indication'}, {'measure': 'Effect Modification of IUD Type on Breastfeeding Status for IUD Expulsion', 'timeFrame': 'Up to 11 years', 'description': 'Propensity score-adjusted hazard ratios to evaluate the extent to which type of IUD (LNG-IUD vs. copper IUD) modified the association between IUD expulsion and breastfeeding among women who were and were not breastfeeding at the time of first observed IUD insertion'}, {'measure': 'Effect Modification of IUD Type on Postpartum Timing for IUD Expulsion', 'timeFrame': 'Up to 11 years', 'description': 'Adjusted for propensity score and breastfeeding status, to evaluate the extent to which type of IUD (LNG-IUD vs. copper IUD) modified the association between IUD expulsion and postpartum timing of IUD insertion for women with IUD insertion at different time periods postpartum (i.e., ≤ 6 weeks, \\> 6 and ≤ 14 weeks, \\> 14 and ≤ 52 weeks) versus IUD insertion more than 52 weeks postpartum, including no recorded delivery within the past 52 weeks, at the time of the first observed IUD insertion. Reference group: LNG-IUD or Copper IUD, \\> 52 weeks or no delivery'}, {'measure': 'Number of Indicators of a Potentially Difficult Insertion, Overall, by Breastfeeding Status, and by Postpartum Timing of IUD Insertion-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'To describe the prevalence of indicators of a difficult IUD insertion (e.g., need for cervical dilation, ultrasound guidance, paracervical block, clinician not indicating difficulty, use of misoprostol among all users)'}, {'measure': 'Number of Indicators of a Potentially Difficult Insertion, Overall, by IUD Type and by Menorrhagia Status-first Observed IUD Insertions', 'timeFrame': 'Up to 11 years', 'description': 'To describe the prevalence of indicators of a difficult IUD insertion (e.g., need for cervical dilation, ultrasound guidance, paracervical block, clinician not indicating difficulty, use of misoprostol among all users)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Contraception', 'Breast-feeding', 'Electronic medical records', 'Uterine perforation', 'Expulsion of intrauterine device'], 'conditions': ['Intrauterine Devices']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer products'}]}, 'descriptionModule': {'briefSummary': 'Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).\n\nThe study analyzed the risks that the IUD was expelled or perforated the womb for the following group comparisons:\n\n* Women who were breastfeeding at the time of IUD insertion and within 52 weeks postpartum versus women who were not breastfeeding at the time of IUD insertion and within 52 weeks postpartum.\n* Women who had a first observed IUD insertion within different time periods after childbirth (i.e., ≤ 6 weeks, \\> 6 weeks and ≤ 14 weeks, \\> 14 weeks and ≤ 52 weeks) versus women who had their first observed IUD insertion more than 52 weeks after childbirth, including women without a recorded delivery within the past 52 weeks. An additional analysis involved 5-level postpartum timing (i.e., 0 to 3 days, 4 days to ≤ 6 weeks, \\> 6 weeks to ≤ 14 weeks, \\> 14 weeks to ≤ 52 weeks) versus the \\> 52 week postpartum group.\n\nThe study also analyzed the risks that the IUD was expelled or perforated the womb for different types of IUDs. In addition, the study aimed to assess the following interactions:\n\n* The extent to which the type of IUD (IUDs releasing the hormone LNG versus Copper IUDs) modified the risk that an IUD was expelled or perforated the womb in relation to breastfeeding and/ or in relation to the point in time when the IUD was inserted after childbirth.\n* The extent to which the breastfeeding status modified the risk that an IUD was expelled or perforated the womb in relation to the point in time when the IUD was inserted after childbirth.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with IUD-insertion', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with evidence in the database of insertion of an IUD (e.g. levonorgestrel-releasing, copper) during the study time window for each site\n* Enrolled in the database with electronic medical records available for review for at least 12 months before the IUD insertion\n\nExclusion Criteria:\n\n\\- Women with more than 50 years of age at the time of the IUD-insertion'}, 'identificationModule': {'nctId': 'NCT03754556', 'acronym': 'APEX IUD', 'briefTitle': 'Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Study on the Association of Uterine Perforation and Intrauterine Device (IUD) Expulsion With Breastfeeding Status at the Time of IUD Insertion and Postpartum Timing of IUD Insertion in Electronic Medical Record Databases - A Postmarketing Requirement for Mirena', 'orgStudyIdInfo': {'id': '19682'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with IUD', 'description': 'Women with an intrauterine device (IUD) and electronic health records in the Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and the Regenstrief Institute (RI) databases.', 'interventionNames': ['Device: Intrauterine device']}], 'interventions': [{'name': 'Intrauterine device', 'type': 'DEVICE', 'otherNames': ['Levonorgestrel, Copper IUD'], 'description': 'Intrauterine devices, e.g. BAY86-5028 (Mirena, Skyla, Kyleena), Liletta and ParaGard', 'armGroupLabels': ['Women with IUD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Northern California', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '91101', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Southern California', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Regenstrief Institute', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Kaiser Permanente Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}