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临床试验/NCT03266432
NCT03266432Unknown不适用

Thromboelastometry Guided Disseminated Intravascular Coagulation Prevention After Cesarean Section in Pregnant Women With Placenta Previa

Assiut University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年8月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
prevention of Postoperative development of DIC

研究概览

简要总结

Evaluation of the use of thromboelastometry for early identification of the underlying coagulopathy and to guide individualized transfusion therapy to prevent DIC development during ICU stay after cesarean section in women with placenta previa who require a massive blood transfusion.

详细描述

Placenta previa is defined as complete or partial implantation of the placenta in the lower segment of the uterus, Patients present with bleeding per vagina occurring usually in the second and third trimester. Bleeding in placenta previa is associated with maternal morbidity and mortality. Transfusion therapy is integral in the acute management of major obstetric hemorrhage. The most important pregnancy related condition leading to bleeding with high mortality and morbidity rates is DIC. Patients exhibit a tendency for severe bleeding associated with the consumption of platelets and coagulation factors. Massive blood transfusions are listed as the main maternal morbidity indicators6.Therefore, early detection of these predictors of DIC and timely intervention of this life-threatening condition is very important. DIC is a clinical-laboratory diagnosis, and laboratory changes need to be interpreted with knowledge of the patient's underlying disorder. Several laboratory parameters are analyzed together as part of a diagnostic algorithm that includes: Prothrombin time (PT), Activated partial thromboplastin time (aPTT), the platelet count, fibrinogen level, and a marker of fibrin degradation, e.g., D-dimer or the soluble fibrin monomer (SFM) 8. None of these markers are taken in isolation, and a combination of results at different time points is particularly helpful in determining the presence of DIC, owing to the multifaceted nature of DIC9, These reasons highlight a strong need for the development of a point-of-care testing system to accurately and reliably diagnose DIC. Thromboelastography (TEM) provides an extended reflection of clot initiation, propagation, and lysis in whole blood. TEM uses three tests: FIBTEM to reveal impaired fibrinogen function, INTEM to reveal coagulation factor deficiency and EXTEM to reveal extrinsic pathway defects

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • ASA physical status I or II
  • Age: ≥ 18 years
  • Patients with all types of placenta previa
  • Eligible for general anesthesia
  • Elective cesarean section
  • Singleton term pregnancy
  • Normal coagulation profile: prothrombin time (PT), activated partial thromboplastin time (aPTT), the platelet count, fibrinogen level

排除标准

  • Parturient refusal
  • Known coagulopathy
  • Women with a history of cardiac, respiratory, renal, neurologic or endocrine diseases.
  • Eclampsia and preeclampsia
  • Emergency surgeries
  • Foetal abnormalities
  • Drug induced thrombocytopenia as antibiotics

研究组 & 干预措施

60 pregnant women

Other

60 pregnant women diagnosed with placenta previa will take from them 3 blood samples : one pre intervention and two samples postintervention

干预措施: blood samples (Other)

结局指标

主要结局

prevention of Postoperative development of DIC

时间窗: from time of operation till 48 hours postopertive

prevention according to the results of thromboelastometry

次要结局

  • Systolic blood pressure(from time of operation till 48 hours postoperative)
  • prevention of Complications of massive transfusion(from time of operation till 48 hours postoperative)
  • diastolic blood pressure(from time of operation till 48 hours postoperative)
  • heart rate(from time of operation till 48 hours postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Kilany

Assistant lecturer

Assiut University

研究点 (2)

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