A study of thromboelastographic parameters in patients with pre-eclampsia undergoing caesarean delivery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of pre-eclamptic patients with deranged thromboelastographic parameters 24 hours post operatively.
研究概览
简要总结
Pre-eclampsia is a disorder of pregnancy associated with new-onset hypertension, which occurs most often after 20 weeks of gestation accompanied by new-onset proteinuria and other signs or symptoms of pre-eclampsia in the absence of proteinuria.Pre-eclampsia complicates 3.8% of pregnancies in India and represents a significant cause of maternal and perinatal morbidity and mortality.
Women with pre-eclampsia are at a greater risk of cerebrovascular and cardiovascular events, organ failure and disseminated intravascular coagulation. Foetus of these mothers are at greater risk of fetal growth retardation, prematurity and intrauterine death.
The aetiology of pre-eclampsia remains unclear. Currently, generally accepted theories assume that abnormal placental implantation in the early stage of pregnancy causes systemic vascular endothelial cell disorder and dysfunction and may lead to the development of hypertension, proteinuria, blood hypercoagulability, and other clinical manifestations. These changes start reverting with the delivery of the baby. However, most of the thromboembolic complications occur postdelivery. Therefore, it is important to recognise women at risk for these fatal complications.
Thromboelastography (TEG) has become a reliable point-of-care assay for detecting various coagulopathies. The advantages of thromboelastography over traditional coagulation parameters include provision of reliable evidence to diagnose disease related to coagulation defects, as well as real-time assessment to know whether the patient is hypocoagulable, hypercoagulable or fibrinolytic. Limited information exists regarding thromboelastography parameters throughout pregnancy among patients with pre-eclampsia.
Since patients with pre-eclampsia are at risk of thromboembolic complications moreso after Caesarean delivery, it is important to recognise the women at risk and to know whether this hypercoagulable state persists through the entire puerperium. After extensive search of literature, till date there are few studies comparing TEG parameters in patients with pre-eclampsia preoperatively, 24 hours and 5th day postoperatively after Caesarean delivery. Therefore, the present study has been planned to compare TEG parameters in the postpartum period as compared to their pre-operative status in patients with pre-eclampsia.
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
- •Age >18 years.
- •Third trimester(≥32 weeks of gestation) patients with diagnosed pre-eclampsia undergoing Caesarean delivery.
排除标准
- •Patients prescribed preoperative unfractionated heparin,oral anticoagulants or receiving magnesium therapy.
- •Patients with a history of deep vein thrombosis,more than two abortions and smoking.
- •Patients with sepsis.
- •Patients with major blood loss during surgery or requiring postoperative ventilation.
结局指标
主要结局
Percentage of pre-eclamptic patients with deranged thromboelastographic parameters 24 hours post operatively.
时间窗: pre delivery,24 hour and 5th day post caesarean delivery
次要结局
- Thromboelastographic parameters (Mean ± SD) preoperatively, 24 hours and 5th day postoperatively in patients with pre-eclampsia after Caesarean delivery.(Correlation between coagulation parameters (platelet count, PT, INR, aPTT) with Maximum amplitude, Reaction time, Thrombogenic Potential Index and Coagulation Index; and D-dimer and bleeding time with Reaction time, Thrombogenic Potential Index and Coagulation Index preoperatively and 24 hours postoperatively.)