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Prediction of Bleeding in Placenta Previa

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05403203
Enrollment
100
Registered
2022-06-03
Start date
2022-09-01
Completion date
2023-10-31
Last updated
2022-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Previa Bleeding

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

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years

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

Design outcomes

Primary

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

MeasureTime frameDescription
The effect on morbidity of pregnant women .baselineMorbidities 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

Contacts

Primary Contactyoussef khalaf, master
youssefkhalaf99@gmail.com01018061561
Backup ContactMohamed Mahmoud Fahmy Fathalla, prof
mfathalla@aun.edu.eg01154320395

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026