Evaluation of Pre-dose and Post-dose Anti-factor Xa Levels With Enoxaparin Use During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
Study Design This is a prospective, non-blinded, pilot study of gravid patients receiving treatment doses of enoxaparin therapy.
Subjects Subjects will include pregnant women at all gestational ages already receiving a treatment (therapeutic) dose regimen of enoxaparin (1 mg/kg ± 20% SC BID). Patients who are managed by one of the principal or co-investigators at Long Beach Memorial Medical Center Women's Hospital may be readily identified as potential candidates for the study. Additionally, other perinatologists, obstetricians, and resident physicians who prescribe enoxaparin for their patients may ask a co-investigator to consent a woman for the study. Women will be individually counseled by their physicians as to the best antithrombotic drug therapy to use during pregnancy, and in the case of enoxaparin use, may be asked to participate in this study.
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.