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临床试验/NCT04861103
NCT04861103招募中4 期

Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)

University of California, Irvine1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年10月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Afshan B. Hameed, M.D.

Maternal Fetal Medicine Physician

University of California, Irvine

研究点 (1)

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