Clinical trial NCT05403203: Prediction of Bleeding in Placenta Previa
Official title: Prediction of Need of Blood Transfusion > 4 Units of Packed RBCS in Cases Diagnosed With Placenta Previa During Cesarean Section .
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Previa Bleeding
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with placenta previa or accreta after 32 weeks

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

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

Primary outcomes:
measure: Ability of a score of the study to predict the need for blood transfusion > 4 units of packed RBCs
timeFrame: baseline
Secondary outcomes:
measure: The effect on morbidity of pregnant women .
timeFrame: baseline
measure: The effect on mortality of pregnant women .
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
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