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临床试验/NCT01394107
NCT01394107已完成不适用

Evaluation of the Impact of the Thromboprophylactic Dose of LMWH on Coagulation in Pregnant Women.

Charles University, Czech Republic2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Effect of standard prophylactic dose of LMWH on coagulation in pregnant women

研究概览

简要总结

The project aims to clarify the effect of the thromboprophylactic LMWH dose on coagulation in pregnant women just before birth, at the period of maximal physiological hypercoagulable state and with high risk of thromboembolism, the most common cause of maternal mortality in developed countries. Although LMWH are now routinely administered as prevention of thromboembolism, their effect on coagulation in pregnant women was not yet studied. The doses of LMWH in pregnancy are only derived in terms of coagulation from totally different groups of patients (surgical, orthopedic). We therefore will map the effect of thromboprophylactic LMWH dose on coagulation in pregnant women using recently available methods, especially a complex examination of coagulation within 24 h after LMWH application using thrombelastography, including examination with heparinase, and monitoring the effect of LMWH by measuring antiXa and TGT (thrombin generation time) activity. Based on these results we will also evaluate the possible influence of LMWH prophylaxis on the risk of spinal haematoma during neuraxial analgesia/anesthesia for delivery/Caesarean section. On the basis of our pilot results we can presume the current dosage of LMWH in pregnant women is inadequate and that it would be appropriate to adjust presently used dosage. At the same time we want to prove that the standard LMWH thromboprophylaxis in pregnant women does not increase the risk of spinal haematoma during neuraxial blockade. In both situations the targeted outcome is to increase the safety of pregnant women.

详细描述

AIMS OF THE PROJECT:

The aim of this project is to map the effect of the thromboprophylactic dose of LMWH on coagulation of women at the end of pregnancy, using recently available methods and laboratory tests, and simultaneously to evaluate the possible influence of LMWH on incidence of spinal hematoma. The methodology is based primarily on a complex examination of coagulation by thrombelastography (TEG), including comparative tests with heparinase, and on the monitoring effect of LMWH by measuring thrombin generation time (TGT) and levels of AntiXa. At the same time and, in cooperation with the Thrombotic Centre, standard and special laboratory hematology tests will be performed (INR, APTT, TT, fibrinogen, AT III, D-dimer, protein S, protein C, APC resistance, PFA, F VII, F VIII, PFA 100, TAT micro, vWf, APA, t-PA, PAI-1, blood count) together with genetic tests for FV Leiden and prothrombin II mutations.

HYPOTHESIS AND EXPECTED RESULTS:

We assume that with hypercoagulation and other influencing factors in pregnancy, the effect of LMWH on coagulation, compared to the population of non-pregnant women, will be significantly lower. Thus significantly lower will be also the effect of TED prophylaxis. For the same reason we assume that the current thromboprophylactic dosage of LMWH could not affect coagulation of pregnant women enough to increase the risk of spinal hematoma with neuraxial analgesia/anaesthesia administration.

SPECIFIC AIMS:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women undergoing planned caesarean section
  • 39th-40th week of pregnancy
  • age 18-40 years

排除标准

  • disapproval or non-cooperation of the mother
  • allergy to LMWH
  • coagulation disorders or the risk of
  • anticoagulant therapy in the last 3 months
  • signs of infection
  • history of cancer
  • signs of thrombosis or a history of thrombosis
  • the ongoing non-physiological pregnancy
  • significant obesity, or other severe comorbidity

研究组 & 干预措施

Pregnant

20 pregnant women with physiological ongoing pregnancy and undergoing planned caesarean section, without known coagulation disorders, will be included in to the study Inclusion criteria: pregnant women undergoing planned caesarean section, 39th-40th week of pregnancy, age 18-40 years, informed consent.

Control

20 healthy women in fertility age (18-40 years) undergoing elective surgery for other than oncology or inflammatory indication, without known risk factors for coagulation disorders, not using hormonal contraception, informed consent.

结局指标

主要结局

Effect of standard prophylactic dose of LMWH on coagulation in pregnant women

时间窗: 24 hours after LMWH application

To map the coagulation effect of standard prophylactic dose of LMWH in pregnant women at the end of pregnancy. Based on these results, to evaluate the possible prophylactic effect of LMWH on TED prevention in pregnant compared to non-pregnant women.

次要结局

  • Evaluation of the possible influence of LMWH on the potential risk of spinal hematoma development during neuraxial blockade in pregnancy.(24 hours after LMWH application)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan Blaha, MD, PhD.

M.D., PhD.

Charles University, Czech Republic

研究点 (2)

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