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This is a randomized controlled trial to assess the effect of a levonorgesterel-releasing intrauterine device (LNG IUD, MirenaĀ®) versus a copper IUD (ParaguardĀ®) on coagulation parameters known to be associated with risk of thrombosis (blood clots). Both the LNG IUD and the copper IUD are FDA approved devices for contraception.
Women enrolled in this study will be randomized to receive either the LNG IUD or the copper IUD. They will complete a one month bleeding diary prior to insertion of the IUD and again for one month while the IUD is in place. They will undergo phlebotomy (blood draw) at baseline (prior to insertion of the IUD), two and four months. Stored samples will be used to measure D-dimer, C-reactive protein (CRP), antithrombin (AT), factor VIIIc, activated partial thromboplastin time (aPTT) and activated partial thromboplastin time plus activated protein C (aPTT + APC). Both groups will undergo a GYN exam with screening for bacterial vaginosis and gonorrhea/chlamydia cultures prior to insertion of the IUD. A brief survey to assess the women's experience with the IUD, including symptomatology and satisfaction with the device, will be conducted at the four months after insertion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Levonorgestrel-containing intrauterine device insertion |
|
| 2 | Active Comparator | Copper containing intrauterine device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel-containing IUD (MirenaĀ®) | Device | Levonorgestrel-containing intrauterine device insertion |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome of this study will be change in coagulation parameters, with sample size calculations powered to detect a 35% change in D-dimer within groups and a 50% difference between groups. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with IUD device | 4 years | |
| Difference in bleeding patterns between groups | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Penny Fairhurst, RN | Contact | 802-847-0985 | penny.fairhurst@vtmednet.org |
| Name | Affiliation | Role |
|---|---|---|
| Kristen P Wright, MD | University of Vermont | Principal Investigator |
| Julia V. Johnson, MD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont | Recruiting | Burlington | Vermont | 05405 | United States |
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| Copper-containing IUD (ParaguardĀ®) | Device | Copper-containing intrauterine device insertion |
|
|
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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