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The purpose of this retrospective chart review was to identify risks factors for patients associated to Cooper IUD fragmentation upon removal resulting in the requirement of a hysteroscopy evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hysteroscopy | Retrospective chart review for patients who necessitated a hysteroscopic procedure from 2004-2024. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Underwent a Hysteroscopy Procedure Resulting From Intrauterine Device (IUD) Fragmentation Upon Removal | Identify patient risk factors for Cooper IDU fragmentation upon removal requiring a hysteroscopy by completing a retrospective chart review. | January 2004- December 2024 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who underwent IUD removal at the University of Kansas Health System
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| Name | Affiliation | Role |
|---|---|---|
| Annabel Mancillas, MD MPH FACOG | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hysteroscopy | Necessitated a hysteroscopic procedure. Hysteroscopy: Retrospective chart review for those patients who had a hysteroscopy after IUD removal. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2024 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hysteroscopy | Necessitated a hysteroscopic procedure. Hysteroscopy: Retrospective chart review for those patients who had a hysteroscopy after IUD removal. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Customized | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Uterine abnormality | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Who Underwent a Hysteroscopy Procedure Resulting From Intrauterine Device (IUD) Fragmentation Upon Removal | Identify patient risk factors for Cooper IDU fragmentation upon removal requiring a hysteroscopy by completing a retrospective chart review. | Posted | Count of Participants | Participants | January 2004- December 2024 |
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January 2004-December 2024, retrospective chart review.
This study was a retrospective chart review in regards to the incidence of hysteroscopy procedures needed due to IUD fragmentation during removal, therefore Serious Adverse Events and All-Cause mortality were not collected as part of the study chart review process.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hysteroscopy | Necessitated a hysteroscopic procedure. Hysteroscopy: Retrospective chart review for those patients who had a hysteroscopy after IUD removal. | 0 | 0 | 0 | 0 | 0 | 44 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annabel Mancillas, MD MPH FACOG | The University of Kansas Medical Center | 913-588-6200 | amancillas@kumc.edu |
| Jan 21, 2026 |
| Prot_SAP_000.pdf |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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