跳至主要内容
临床试验/NCT07832019
NCT07832019尚未招募不适用

Placenta-Cervical Interface Angle: A Novel Sonographic Marker for Predicting Placenta Accreta Spectrum Severity and Perinatal Outcomes

Necmettin Erbakan University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Predictive performance of the Placenta-Cervical Interface Angle (PCIA) for severe placenta accreta spectrum

研究概览

简要总结

Placenta accreta spectrum (PAS) is associated with substantial maternal and neonatal morbidity, and accurate antenatal prediction of its severity remains challenging. Although several sonographic markers exist, most are subjective and operator-dependent, and few predict surgical complexity or adverse perinatal outcomes. This prospective observational cohort study evaluates the Placenta-Cervical Interface Angle (PCIA), a novel geometric transvaginal ultrasound marker, defined as the angle between the longitudinal axis of the cervical canal and the tangent line drawn to the lower placental edge. The study assesses the predictive performance of the PCIA for severe PAS and its association with intraoperative morbidity and adverse perinatal outcomes.

详细描述

Pregnant women with placenta previa or an anteriorly located low-lying placenta followed at the Perinatology Clinic, Necmettin Erbakan University Faculty of Medicine, will be enrolled prospectively. Using transvaginal ultrasonography in the sagittal plane, the Placenta-Cervical Interface Angle (PCIA) will be measured as the angle formed between the longitudinal axis along the cervical canal and the tangent line to the lower placental edge. All measurements will be performed with an empty bladder in the lithotomy position using a Voluson 8 ultrasound system within the same gestational-age window. Classic sonographic PAS markers will also be assessed, including placental lacunae, bridging vessels, loss of the clear zone, myometrial thickness, bladder-wall invasion, and cervical length. Demographic and clinical variables (age, BMI, gravidity, parity, smoking, IVF versus spontaneous conception, prior cesarean and other uterine surgery) will be recorded. Surgical and perinatal outcomes, including operative time, estimated blood loss, red-blood-cell transfusion, intensive-care requirement, hysterectomy, and neonatal outcomes, will be recorded. To assess reproducibility, a second operator will repeat the measurement in approximately 20% of participants and the intraclass correlation coefficient (ICC) will be calculated. Data will be analyzed with SPSS. The predictive performance of the PCIA for severe PAS and adverse perinatal outcomes will be evaluated by ROC analysis, with the optimal cut-off determined by the Youden index; sensitivity, specificity, and positive and negative predictive values will be calculated. Multivariable logistic regression will be used to identify independent predictors. A p-value below 0.05 will be considered statistically significant.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Gestational age greater than 20 weeks
  • Placenta previa or low-lying placenta
  • Suspected placenta accreta spectrum
  • History of cesarean delivery

排除标准

  • Major fetal anomaly
  • Multiple pregnancy
  • Uterine malformation
  • Inadequate image quality
  • Active vaginal bleeding

研究组 & 干预措施

Pregnant women at risk of PAS

Pregnant women at or beyond 20 weeks of gestation with placenta previa or an anterior low-lying placenta and suspected placenta accreta spectrum, undergoing transvaginal measurement of the Placenta-Cervical Interface Angle and followed to delivery.

干预措施: Pregnant women at risk of PAS (Procedure)

结局指标

主要结局

Predictive performance of the Placenta-Cervical Interface Angle (PCIA) for severe placenta accreta spectrum

时间窗: From antenatal ultrasound (>=20 weeks) to postoperative histopathological confirmation at delivery

Diagnostic accuracy of the sonographically measured PCIA for predicting surgically or histologically confirmed severe PAS, expressed as area under the ROC curve (AUC), sensitivity, specificity, and positive and negative predictive values. The optimal cut-off is determined by the Youden index.

次要结局

  • Estimated intraoperative blood loss(At delivery / cesarean surgery)
  • Adverse neonatal outcome(At delivery and the immediate neonatal period)
  • Inter-observer reproducibility of PCIA measurement(At the time of antenatal ultrasound assessment)
  • Red blood cell transfusion(At delivery and during the perioperative period)
  • Operative time(At delivery / cesarean surgery)
  • Hysterectomy(At delivery / cesarean surgery)
  • Intensive care unit admission(During the postoperative hospital stay)

研究者

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

Hatice Şule Mazloomyar

Specialist, Obstetrics and Gynecology / Perinatology

Necmettin Erbakan University

研究点 (1)

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