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Clinical Trials/NCT05403203
NCT05403203
Unknown
Not Applicable

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

Assiut University0 sites100 target enrollmentSeptember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Placenta Previa Bleeding
Sponsor
Assiut University
Enrollment
100
Primary Endpoint
Ability of a score of the study to predict the need for blood transfusion > 4 units of packed RBCs
Last Updated
3 years ago

Overview

Brief Summary

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 .

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
October 2023
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Youssef khalaf makary

Principal investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • abruption placenta
  • unavilable or limited avilability of blood group

Outcomes

Primary Outcomes

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

Time Frame: 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

Secondary Outcomes

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

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