Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorAssiut University
About this trial
Placenta accreta spectrum (PAS) is a serious pregnancy complication where the placenta attaches too deeply into the wall of the uterus. This condition can lead to severe complications during delivery, including heavy bleeding, the need for blood transfusions, intensive care unit (ICU) admission, or the surgical removal of the uterus (hysterectomy).
Currently, doctors primarily use ultrasound to detect PAS before birth, but the accuracy of ultrasound can vary depending on the equipment and the doctor's experience. The main goal of this study is to determine if routine, simple blood tests can serve as an additional tool to help doctors predict which mothers are at the highest risk of developing PAS.
The study will involve pregnant women who have placenta previa (a low-lying placenta) and a history of a previous cesarean delivery. Researchers will collect a standard blood sample when the mother is admitted to the hospital to look at specific markers, including a complete blood count (CBC) and blood clotting (coagulation) factors.
By comparing these admission blood test results with the actual diagnosis of PAS confirmed during delivery, researchers hope to identify a reliable way to predict this condition. Improving the early detection of PAS could help medical teams better prepare for high-risk deliveries, optimize surgical planning, and ultimately improve health outcomes for mothers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18-40 years
Placenta previa diagnosed by ultrasound
Singleton pregnancy
Gestational age >28 weeks
Disqualifiers
Intrauterine fetal demise (IUFD)
Intrauterine growth restriction (IUGR)
Premature rupture of membranes (PROM)
Chorioamnionitis
Trial population
The study population consists of pregnant women aged 18 to 40 years presenting to the Women's Health Hospital at Assiut University. Eligible participants must have a singleton pregnancy at a gestational age greater than 28 weeks, a diagnosis of placenta previa confirmed by ultrasound, a history of previous cesarean delivery, and be hemodynamically stable upon admission. Patients will be excluded if they present with intrauterine fetal demise (IUFD), intrauterine growth restriction (IUGR), premature rupture of membranes (PROM), chorioamnionitis, known blood diseases or bleeding tendencies, hypertension, or diabetes mellitus.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
130 Participants
are grouped into 1 trial groupGroup A: Patients with Placenta Previa and Previous Cesarean Delivery
Trial outcomes
Primary outcomes
1
Diagnostic Accuracy of the Systemic Immune-Inflammation Index (SII) for Predicting Placenta Accreta Spectrum
Evaluation of the predictive value of the maternal Systemic Immune-Inflammation Index (SII) for diagnosing placenta accreta spectrum (PAS). The SII is calculated from the complete blood count (neutrophils × platelets / lymphocytes) collected on hospital admission. Diagnostic accuracy will be quantified using the Area Under the Receiver Operating Characteristic (ROC) curve to determine the optimal cut-off point, sensitivity, and specificity. The reference standard diagnosis of PAS is confirmed via intraoperative assessment at the time of delivery.
Time frame
Within 12 weeks of enrollmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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