The Effect of a Levonorgestrel-releasing Intrauterine Device (IUD) Versus a Copper Containing IUD on Risk of Blood Clots
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 52 |
| Updated: | 4/2/2016 |
| Start Date: | December 2007 |
| End Date: | July 2012 |
| Contact: | Penny Fairhurst, RN |
| Email: | penny.fairhurst@vtmednet.org |
| Phone: | 802-847-0985 |
The Effect of a Levonorgestrel-releasing Intrauterine Device Versus a Copper Containing Intrauterine Device on Coagulation Parameters
This is a randomized controlled trial to assess the effect of a levonorgesterel-releasing
intrauterine device (LNG IUD, Mirena®) versus a copper IUD (Paraguard®) 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.
intrauterine device (LNG IUD, Mirena®) versus a copper IUD (Paraguard®) 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.
Inclusion Criteria:
- Women who desire long-term, reversible contraception
Exclusion Criteria:
- Women with coagulopathies
- History of thrombotic events
- Pregnancy
- Active pelvic infection
- Known hypersensitivity to progestin
- Undiagnosed vaginal bleeding
- Wilson's disease
- Sensitivity to copper
- Uterine anatomy that precludes insertion of an IUD
- Women with multiple sexual partners and history within the last 5 years of alcoholism
or drug abuse.
- Additionally, women must be greater than 3 months postpartum and have had two months
without oral contraceptive pills or 6 months without Depo Provera prior to
enrollment.
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