Comparison of Different Anticoagulation Regimens in Pregnant Patients With Prosthetic Heart Valves: A Randomized Clinical Trial
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
- 否
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
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
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
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
MEHMET OZKAN
Principal Investigator, MD., Prof., Head of Cardiology
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
