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临床试验/NCT07826247
NCT07826247尚未招募不适用

Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Patients With Placenta Previa

Assiut University0 个研究点目标入组 130 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
130
主要终点
Diagnostic Accuracy of the Systemic Immune-Inflammation Index (SII) for Predicting Placenta Accreta Spectrum

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: 18-40 years
  • Placenta previa diagnosed by ultrasound
  • Singleton pregnancy
  • Gestational age >28 weeks
  • Previous cesarean delivery
  • Hemodynamically stable on admission

排除标准

  • 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)

研究组 & 干预措施

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).

结局指标

主要结局

Diagnostic Accuracy of the Systemic Immune-Inflammation Index (SII) for Predicting Placenta Accreta Spectrum

时间窗: Within 12 weeks of enrollment

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariam Khalifa Abdelnour Dous

Resident of Obstetrics and Gynecology

Assiut University

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