A comparative study of thromboelastographic parameters in healthy pregnant women undergoing Caesarean or vaginal delivery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Proportion of healthy pregnant women having deranged thromboelastographic parameters 24
研究概览
简要总结
The physiological changes in pregnancy result in a hypercoagulable state. The concentration of most coagulation factors increases, while factor XI and factor XIII decreases leading to activation of the clotting system. During the first 3 to 5 days postpartum, changes in various procoagulant factors may account for greater incidence of thrombotic complications during the puerperium.
It has been reported that the risk of thrombosis after vaginal delivery was 1 per 1000 while this risk reaches 3 per 1000 after Caesarean section. The mortality associated with venous thromboembolism after Caesarean section is increased 10-fold compared with women who undergo vaginal delivery.
The conventional blood coagulation tests (prothrombin time, activated partial thromboplastin time, international normalised ratio, platelet count, bleeding time) do not provide a complete picture of hemostasis due to their inability to assess some coagulation factors (such as Factor 13), platelet function and the activity of the fibrinolytic system.
On the other hand, thromboelastography (TEG) is a single test that quantitatively measures the ability of whole blood to form a clot and has become a reliable point-of-care assay for detecting various coagulopathies. In this regard, the advantage of thromboelastography over conventional coagulation parameters include real time assessment to know whether the patient is hypocoagulable, hypercoagulable or fibrinolytic. The aim of the present is to evaluate the role of TEG, in identifying haemostatic alterations in healthy pregnant women undergoing Caesarean delivery and vaginal delivery.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy pregnant women >18 years posted for Caesarean delivery under spinal anaesthesia or vaginal delivery.
排除标准
- •Patients undergoing assisted vaginal delivery (use of forceps and vacuum) 2)Patients receiving preoperative unfractionated heparin, oral anticoagulants or magnesium sulphate 3)Patients with a history of deep vein thrombosis or more than two abortions 4)Patients with history of smoking 5)Patients with hereditary thrombophilia, anti-phospholipid syndrome 6)Patients with sepsis 7)Patients with platelet count < 1 lakh/ mm3.
结局指标
主要结局
Proportion of healthy pregnant women having deranged thromboelastographic parameters 24
时间窗: Predelivery, 24 hours after delivery and day of discharge
hours after Caesarean delivery and those after vaginal delivery
时间窗: Predelivery, 24 hours after delivery and day of discharge
次要结局
- 1)Thromboelastographic parameters (Mean ± SD) pre-delivery, 24 hours post-delivery and on the day of discharge in healthy pregnant women after Caesarean or vaginal delivery.(2)Correlation between platelet count, PT, INR, aPTT with MA, R and CI and D-dimer and BT with R, CI and TPI pre-delivery and 24 hr post-delivery in healthy pregnant women undergoing Caesarean delivery and vaginal delivery.)