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临床试验/NCT02240927
NCT02240927Unknown不适用

Comparison of Different Anticoagulation Regimens in Pregnant Patients With Prosthetic Heart Valves: A Randomized Clinical Trial

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Fetal Complications

研究概览

简要总结

Pregnancy is associated with increased risk of thrombosis among women with mechanical prosthetic heart valves.However, the best anticoagulant treatment strategies for pregnant patients with prosthetic heart valves have been controversial. In this study the investigators wanted to identify the most effective and safe regimen among different anticoagulant regimens.

详细描述

Four different anticoagulant treatment regimens for pregnant patients with prosthetic heart valves have been described. In the first arm warfarin is stopped and enoxaparine is started in 1mg/kg dose twice a day which is monitored by weekly anti-Xa levels (between 0.7-1.2) during the first trimester and followed by only warfarin after first trimester. In the second arm, if the patient's warfarin consumption is more than 5 mg before pregnancy, warfarin dose is decreased to 2.5 mg during the first trimester combined with enoxaparine in 1mg/kg dose twice a day; adjusted by measurements of anti-Xa levels (between 0.5-1) weekly until the end of 12th week of pregnancy . In the third arm warfarin dose is decreased to 4 mg during the first trimester combined with enoxaparine given in a similar manner. If the patient's therapeutic warfarin dose is less than 5 mg before pregnancy, warfarin is continued in the same dose during all the pregnancy in the 4th arm. All patients are followed by serial transesophageal echocardiography performed at 0,3,6 and 9. months of pregnancy. Informed consent is taken from all patients. After delivery the babies are examined by a experinced pediatrician and pediatric cardiologist for any congenital anomalies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant patients with prosthetic heart valves

排除标准

  • 未提供

研究组 & 干预措施

Enoxaparine and 2.5 mg warfarin

Active Comparator

If the patient's therapeutic warfarin dose is more than 5 mg before pregnancy, warfarin dose is decreased to 2.5 mg during the first trimester and combined with enoxaparine in 1mg/kg dose twice a day. Enoxaparine dose is adjusted according to anti-factor Xa levels (between 0.5-1.0). Full dose warfarin is continued after first trimester and dose is regulated according to INR (between 2.5-4)

干预措施: Enoxaparine and 2.5 mg Warfarin (Drug)

Enoxaparine and 4 mg warfarin

Active Comparator

If the patient's warfarin consumption dose is more than 5 mg before pregnancy, warfarin dose is decreased to 4 mg during the first trimester and combined with enoxaparine in 1mg/kg dose twice a day. Enoxaparine dose is adjusted according to anti-factor Xa levels (between 0.5-1). Full dose warfarin is continued after first trimester and dose is regulated according to INR level (between 2.5-4).

干预措施: Enoxaparine and 4mg Warfarin (Drug)

Warfarin

Active Comparator

If the patient's therapeutic warfarin dose is less than 5 mg before pregnancy, warfarin is continued in the same dose during all the pregnancy and the dose is adjusted according to INR level (between 2.5-4).

干预措施: Warfarin (Drug)

结局指标

主要结局

Fetal Complications

时间窗: 12 months

Any congenital anomalia which may be attributed to warfarin or enoxaparine usage during pregnancy

Successful pregnancy

时间窗: 12 month

In the absence of fetal and maternal fatal or nonfatal major complications successful pregnancy

Maternal Complications

时间窗: Participants will be followed during pregnancy and postpartum period, an expected average of 12 months

* Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion, abortus, placental hemorrhage, Assessment of an increase in thrombus burden more than 50% and/or progression of PVT obstruction by transesophageal echocardiography. * Nonfatal minor complication: Bleeding without need for transfusion, TIA.

次要结局

未报告次要终点

研究者

发起方
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

MEHMET OZKAN

Principal Investigator, MD., Prof., Head of Cardiology

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

研究点 (1)

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