跳至主要内容
临床试验/NCT05403203
NCT05403203Unknown不适用

Prediction of Need of Blood Transfusion > 4 Units of Packed RBCS in Cases Diagnosed With Placenta Previa During Cesarean Section .

Assiut University0 个研究点目标入组 100 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Ability of a score of the study to predict the need for blood transfusion > 4 units of packed RBCs

研究概览

简要总结

To assess the ability of clinical and sonographic variables to predict the need of blood transfusion > 4 units of packed RBCS in women undergoing cesarian section for placenta previa .

详细描述

Womenwith placenta previa after 32 weeks will be assessed for participation if they are eligible an adequate data will be taken :

  • Clinical factors : including maternal age, abortion history, cesarean section history, gestational age at delivery, whether the operation will be carried out as an emergency surgery, and whether bleeding has started before the operation, will evaluated. The number of abortion history will be counted only if a dilatation and curettage was performed. Preoperative hemoglobin and hematocrit values will be checked. The amount of PRBCs transfused during operation will be measured.

-Ultrasonographic factor: Adiagnosis of placenta previa was made when the placenta covered the internal orifice of the cervix after 32 weeks' gestation. We will check for the presence of a hypoechoic area between the myometrium and the placenta. The vascularity of the placenta will be classified as normal or hypervascular on color Doppler imaging. We will examine the location of placenta ( anterior . posterior. Anterior with lateral deviation. Posterior with lateral deviation) and presence ofintraplacental lacunae (an irregular area of low echogenicity larger than 1 cm × 1 cm in the placental parenchyma)

  • Intraoperative factor:

Assess surgeon years of experience Management plan hemostatic sutures other conservative management hysterectomy (primary or secondary) Assessment of amount of blood taken in 24 h from operation

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women with placenta previa after 32 weeks
  • women with placenta accreta after 32 weeks

排除标准

  • abruption placenta
  • unavilable or limited avilability of blood group

结局指标

主要结局

Ability of a score of the study to predict the need for blood transfusion > 4 units of packed RBCs

时间窗: baseline

It is a questionnaire Data collection of full personal history and obstetric and gynocological history and sonographic data . The data will be collected and entered on Microsoft access data base to be analysed using the Statistical Package for Social Science (SPSS Inc. ,Chicago,version 21) groups difference will be assessed by independent sample t-test and Chi square for prediction of receiving \>4 units 0f packed RBCS will be assessed by logistic Regression then a scoring system of factors that will prove independently significant . The predictive accuracy of the scoring system will be analysed using ROC curve

次要结局

  • The effect on morbidity of pregnant women .(baseline)
  • The effect on mortality of pregnant women .(Baseline)

研究者

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

Youssef khalaf makary

Principal investigator

Assiut University

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Prediction of Bleeding in Placenta Previa | 临床试验