Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Factor Xa levels
研究概览
简要总结
Pregnancy is associated with a increased risk of developing blood clots. There is nearly a 5 times greater risk of developing a blood clot in pregnancy. Lovenox is a medication that helps to prevent the body from developing clots. It is safe to use in pregnancy. Previous studies have demonstrated that despite recommendation of Lovenox, to prevent blood clots, the majority of patient's (70 to 90%) did not receive adequate levels of Lovenox at times throughout the day, which likely increases the risk of developing clots. The increase in blood volume and increase in kidney function that occurs in pregnancy may contribute to the inadequate levels. Currently the recommendation for pregnant and nonpregnant patients requiring Lovenox, is to calculate the daily dose of Lovenox and split the dose, giving half in the morning and the other half in the evening. This research study proposes that due to changes in the body during pregnancy that the daily Lovenox dosing be split into three times a day to achieve more consistent levels of Lovenox than twice a day in pregnant women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous or multiparous women with single intrauterine pregnancies who require therapeutic low molecular weight heparin during their pregnancy.
- •Participants must be age 18 or older.
排除标准
- •Women with multiples.
- •Women less than age 18
- •History of Heparin Induced Thrombocytopenia (HIT)
- •Allergy to enoxaparin
研究组 & 干预措施
Factor Xa levels in pregnant women with therapeutic Lovenox divided into three times a day dosing
Therapeutic Lovenox dosing split into three times a day dosing for 5 day. Xa levels a measured.
干预措施: Lovenox (Drug)
结局指标
主要结局
Factor Xa levels
时间窗: 4 hours after injection
次要结局
未报告次要终点
研究者
Afshan B. Hameed, M.D.
Maternal Fetal Medicine Physician
University of California, Irvine
