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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
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The purpose of this study is to compare delayed vs. immediate insertion of the Copper T 380 IUD after termination of pregnancy after 12 weeks.
Patients presenting to ParkMed Women's Clinic and the Reproductive Choice clinic at Bellevue Hospital for second trimester termination will be offered participation in this study. They will be randomized to either delayed or immediate Copper T 380A IUD insertion. The subjects will be seen at a 6 month follow-up visit and Copper T 380A IUD placement will be verified by physical exam. At this 6 month follow-up visit, subjects will fill out a satisfaction questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A/Immediate | Active Comparator | The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure |
|
| B/Delayed | Active Comparator | The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copper T 380A IUD | Device | Copper T 380A IUD will be placed at the 2-4 week post-operative visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Use of IUD | Number of participants using Copper T380A IUD 6 months after surgery | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Expulsion | IUD was not removed by provider but fell out on its own. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miriam L. Cremer, MD, MPH | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellevue Hospital | New York | New York | 10016 | United States | ||
| Parkmed Women's Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | A/Immediate | The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure. |
| FG001 | B/Delayed | The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure. Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
215 subjects were enrolled and randomized to the A/Immediate or B/Delayed group.
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| ID | Title | Description |
|---|---|---|
| BG000 | A/Immediate | The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure. |
| BG001 | B/Delayed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Use of IUD | Number of participants using Copper T380A IUD 6 months after surgery | Posted | Number | participants | 6 months |
|
6 months
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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 | A/Immediate | The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Expulsion | Reproductive system and breast disorders | Non-systematic Assessment |
IUD presence not always confirmed by a provider at 6-month visit but self-reported.
Study not powered to detect a difference in expulsion rates due to prohibitively high sample size.
Very high-risk population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miriam Cremer MD MPH | Basic Health International | (646) 593-8694 | miriam.cremer@gmail.com |
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| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
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| New York |
| New York |
| 10017 |
| United States |
The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure. Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Gestational age | Mean | Full Range | weeks |
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| Secondary | Expulsion | IUD was not removed by provider but fell out on its own. | The analysis here includes the 64/71 A/Immediate arm and 26/88 B/Delayed arm who received an IUD. In the A/Immediate arm, 5 women changed their mind post-randomization and in 2 cases, the provider chose not to place it. In the B/Delayed arm, reasons included not returning for follow-up visit, changing mind, and provider not wanting to place IUD. | Posted | Number | percentage of expulsions | 6 months |
|
|
|
| 0 |
| 104 |
| 2 |
| 104 |
| EG001 | B/Delayed | The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure. Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit. | 0 | 111 | 0 | 111 |
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