- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Diagnostic Accuracy of the Systemic Immune-Inflammation Index (SII) for Predicting Placenta Accreta Spectrum
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Markers for PAS in Previa
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