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- Ensayo clínico NCT07826247
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Patients With Placenta Previa
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age: 18-40 years
- Placenta previa diagnosed by ultrasound
- Singleton pregnancy
- Gestational age >28 weeks
- Previous cesarean delivery
- Hemodynamically stable on admission
Exclusion Criteria:
- Intrauterine fetal demise (IUFD)
- Intrauterine growth restriction (IUGR)
- Premature rupture of membranes (PROM)
- Chorioamnionitis
- Patients with known blood disease or bleeding tendency
- Hypertension (HTN)
- Diabetes mellitus (DM)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Patients with Placenta Previa and Previous Cesarean Delivery
This cohort consists of pregnant women aged 18 to 40 years with a singleton pregnancy at >28 weeks gestational age.
Participants must be diagnosed with placenta previa via ultrasound, have a history of previous cesarean delivery, and be hemodynamically stable on admission.
Participants will undergo an antenatal ultrasound to assess for signs of placenta accreta spectrum (PAS).
Venous blood samples will be collected upon admission to evaluate complete blood count (CBC) parameters (including calculation of inflammatory indices like NLR, PLR, SII, and SIRI) and a coagulation profile (PT, PC, INR, aPTT, and D-dimer).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Diagnostic Accuracy of the Systemic Immune-Inflammation Index (SII) for Predicting Placenta Accreta Spectrum
Periodo de tiempo: Within 12 weeks of enrollment
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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.
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Within 12 weeks of enrollment
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Markers for PAS in Previa
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