Evaluation of Pre-dose and Post-dose Anti-factor Xa Levels With Enoxaparin Use During Pregnancy
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Purpose
Venous thromboembolism is a condition that causes formation of blood clots in the body. It may have life threatening consequences if the leg veins, lungs or the brain blood vessels are involved. In pregnancy, a woman's baseline risk for forming blood clots is increased.
Women with a known prior blood clot during pregnancy, artificial heart valves or other genetic conditions are at a very high risk for these complications during their pregnancy. It has been well established that these women benefit from medical treatment with a blood thinning medication in their pregnancies to prevent further formation of blood clots. These medications are called Heparins and are given as shots. Prior studies have suggested that a type of Heparin called "low molecular weight heparin" (Enoxaparin=Lovenox®) is well suited for use in pregnancy as it does not affect the baby and has a very low complication rate.
The standard dose given for treatment of these patients has been established previously. However, there is a concern that complications may occur if the concentration of this medication falls below its effective level. It is of particular importance in pregnancy, as the rate of breakdown of this medication increases in pregnancy and may lead to lowering of its effective levels.
Our study will evaluate the blood levels of enoxaparin before and after administration of this medication in pregnant women who are receiving this drug for treatment. This will determine whether an increase in the dose or an increase in the frequency of dosing might further improve the standard of care.
| Condition |
|---|
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Pregnancy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Estimated Enrollment: | 15 |
| Study Start Date: | April 2004 |
| Study Completion Date: | December 2007 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Obstetrics clinic
Inclusion Criteria:
- Nulliparous or multiparous women with intrauterine pregnancies who are receiving twice daily treatment doses of enoxaparin (1 mg/kg ± 20% SC BID).
- Subjects who consent to the study.
Exclusion Criteria:
- Women who are not pregnant.
- Women who are receiving enoxaparin at prophylactic doses (i.e., 30 mg twice daily or 40 mg daily).
- Women who are currently receiving another LMWH or UFH.
- Women who are receiving other concomitant anticoagulant medications, such as warfarin, lepirudin, or argatroban.
- Subjects who are unable or unwilling to give informed consent.
- Women who, in the judgment of the investigators, would not be in the best interest of the patient to participate in the study.
Contacts and Locations| United States, California | |
| Long Beach Memorial Medical Center | |
| Long Beach, California, United States, 90806 | |
| Principal Investigator: | Afshan B Hameed, MD | University of California, Irvine |
More Information
No publications provided by University of California, Irvine
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00319176 History of Changes |
| Other Study ID Numbers: | 162-04 |
| Study First Received: | April 26, 2006 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
|
Pregnancy Enoxaparin Anticoagulation |
Additional relevant MeSH terms:
|
Enoxaparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013