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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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This is a randomized controlled trial among women who deliver by cesarean at UNC Women's Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of the Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the 4-8 week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months later than women who plan on receiving an IUD 4-8 weeks after delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interval IUD Placement | No Intervention | Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery | |
| Immediate Postplacental IUD placement | Experimental | Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Postplacental Placement of an IUD during cesarean delivery | Device | Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta |
| Measure | Description | Time Frame |
|---|---|---|
| IUD Use | The use of an IUD at 6 months postpartum is the primary outcome measure | 6 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| IUD Expulsion | 0-6 months postpartum | |
| Women's Satisfaction With IUDs | 0-6 months postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erika Levi, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina, Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26241250 | Derived | Levi EE, Stuart GS, Zerden ML, Garrett JM, Bryant AG. Intrauterine Device Placement During Cesarean Delivery and Continued Use 6 Months Postpartum: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):5-11. doi: 10.1097/AOG.0000000000000882. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Interval IUD Placement | Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery |
| FG001 | Immediate Postplacental IUD Placement | Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Interval IUD Placement | Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery |
| BG001 | Immediate Postplacental IUD Placement |
| 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 | IUD Use | The use of an IUD at 6 months postpartum is the primary outcome measure | Posted | Number | participants | 6 months postpartum |
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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 | Interval IUD Placement | Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uterine Perforation | Reproductive system and breast disorders | Uterine Perforation with IUD placement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erika Levi, MD and Gretchen Stuart, MD | University of North Carolina | (919) 843-5633 | Erika.Levi@gmail.com |
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Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Secondary | IUD Expulsion | Posted | Number | participants | 0-6 months postpartum |
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| Secondary | Women's Satisfaction With IUDs | Posted | Number | percentage of participants satisfied | 0-6 months postpartum |
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| 0 |
| 56 |
| 1 |
| 56 |
| EG001 | Immediate Postplacental IUD Placement | Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta | 0 | 56 | 0 | 56 |
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