Prediction of Bleeding in Placenta Previa

• Conditions: Placenta Previa Bleeding

• Registration Number: NCT05403203
• Lead Sponsor: Assiut University

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

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-30
• Study First Posted: 2022-06-03
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-15
• Study Start: 2022-09-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ability of a score of the study to predict the need for blood transfusion > 4 units of packed RBCs	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 Outcome Measures

Name	Time	Method
The effect on morbidity of pregnant women .	baseline	Morbidities were defined as organ system dysfunctions related to severe obstetric hemorrhage and included: acute respiratory distress syndrome (impairment of respiratory function needing ventilation, oxygen supplementation, or decreased physical activity level as compared to pre-pregnancy), cerebral impairment (seizures, unconsciousness, or cognitive/motor loss), renal failure (creatinine \> 1.5 mg/dL or increased \>1.0 mg/dL above baseline, oliguria; \<120 mL output in 4-hour intervals), and heart failure (impairment of cardiac function according to New York Heart Disease Classification)
The effect on mortality of pregnant women .	Baseline