Early Versus Late Post Caesarean Section Oral Anticoagulation Initiation and Risk of Maternal Complications in Patients With Mechanical Heart Valve Prosthesis
试验速览
- 阶段
- 不适用
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Need for any other intervention e.g. redo valve replacement surgery in case of a stuck valve
研究概览
简要总结
A randomized cohort study applied to patients with mechanical heart valve prosthesis who will be delivered by caesarean section at or after 28 weeks of gestation . Using a table of random numbers, participants will be divided into 2 equal groups. Group A (57 patients) in which warfarin will be started day 2 after caesarean delivery (i.e. 24 hours postoperative), and group B (57 patients) in which warfarin will be started day 5 after caesarean delivery, then maternal complications are compared among these 2 groups.
详细描述
-Background and Rationale:
Cardiac valve replacement surgery has saved the lives of hundreds of thousands of patients with acquired (e.g. rheumatic) or congenital cardiac disorders (McLintock, 2011).
Pregnancy induces a state of hypercoagulability with a high risk of thromboembolism. The thromboembolic risks are much higher in patients with mechanical prosthetic heart valves (Hanania, 2001).
Vitamin K antagonists (VKAs) constitute the safest anticoagulation for mechanical heart valves (MHV) whether within or outside of pregnancy. However, these drugs can cross the placenta and can cause embryopathy, fetopathy, and bleeding. In the peripartum period, there is also an increase in the bleeding risk for both, the mother and the neonate. (Bhagra et al, 2017).
On the other hand, heparins, both unfractionated (UFH) and low molecular weight heparin (LMWH), do not cross the placenta and are considered safe for the fetus. However, heparin seems an inadequate anticoagulant when used for MHV over long periods such as in pregnancy. This is due in part to the thrombogenic nature of MHV (Arya, 2019).
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with mechanical prosthetic heart valves who are planned to deliver by caesarean delivery, provided that the gestational age at delivery is 28 weeks of gestation or more whether singleton or multi-fetal pregnancy.
排除标准
- •Patients with right-sided mechanical heart valves.
- •Patients with a history of any thrombotic events e.g. Stuck prosthetic valve, or cerebrovascular stroke, etc.
- •Patients with hypertensive disorders.
- •Diabetic patients.
- •Patients with known bleeding disorders or coagulation defects.
- •Patients with known thrombophilia.
- •Patients who refuse to share in the study.
研究组 & 干预措施
Day 2 warfarin group
warfarin will be administered on day 2 after caesarean section (in a dose that achieves therapeutic level as indicated by the cardiology consultant)
干预措施: Warfarin Sodium started on Day 2 after caesarean section (in a dose that achieves a therapeutic level as indicated by the cardiology consultant) (Drug)
Day 5 warfarin group
warfarin will be administered on day 5 after caesarean section (in a dose that achieves therapeutic level as indicated by the cardiology consultant)
干预措施: Warfarin Sodium started on day 5 after caesarean section (in a dose that achieves a therapeutic level as indicated by the cardiology consultant) (Drug)
结局指标
主要结局
Need for any other intervention e.g. redo valve replacement surgery in case of a stuck valve
时间窗: 14 days
Need for abdominal re-exploration or wound hematoma evacuation
时间窗: 14 days
Occurrence of intra-abdominal bleeding
时间窗: 14 days
Maternal death
时间窗: 14 days
Occurrence of subcutaneous and / or sub-rectus hematoma
时间窗: 14 days
Need for blood transfusion
时间窗: 14 days
Occurrence of a valve thrombosis or other thromboembolic manifestations e.g. stroke
时间窗: 14 days
次要结局
- Length of hospital stay since delivery till discharge(14 days)
- Estimation of the average total intraoperative and postoperative blood loss in the first 24 hours after caesarean section(24 hours)
研究者
Amr Samir Fouad
assistant lecturer
Cairo University