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临床试验/NCT05996926
NCT05996926尚未招募不适用

Diagnostic Correlation Between Saline Infused Sonohystrography and Three Dimensional Transvaginal Ultrasound in the Assessment of Cesarean Section Scar Defect. A Study of a Diagnostic Test Accuracy

Cairo University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年8月30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
72
试验地点
1
主要终点
Diagnostic Accuracy of Cesarean Scar Defect Assessment Using 3D TVS

研究概览

简要总结

To compare accuracy of three dimensional transvaginal ultrasound versus the "gold standard" saline infused sonography for assessing the characteristics, frequency and appearance of caesarean scar defects in symptomatic patients with a history of cesarean section.

详细描述

Cesarean section (CS) is a frequently performed surgical procedure in obstetric practice. With a significant number of women undergoing this procedure annually, studying its impact on future reproductive capacity has become increasingly important.

The prevalence of cesarean deliveries is rising and constitutes about one-third of all births in both the USA and Italy. As the use of cesarean delivery increases, so do the associated complications, including cesarean scar pregnancy, morbidly adherent placenta, and Cesarean section scar dehiscence and rupture.

Cesarean scar defects (CSD) are described using various terms (pouch, niche, or isthmocoele) and are characterized by thinning of the myometrium or a uterine scar dehiscence, often appearing as a triangular shape within the endometrial cavity.

The exact prevalence of symptomatic Cesarean scar defects varies due to factors like population differences and lack of standardized criteria. Clinical presentations of Cesarean scar defects range from no symptoms to abnormal uterine bleeding, infertility, dyspareunia, and pelvic pain.

Women with a history of Cesarean section are considered high-risk during pregnancy and require specialized assessments to ensure scar integrity. Saline-infused sonography (Sonohystrography) is effective for demonstrating caesarean niches, although transvaginal ultrasound (TVS) is more accessible and commonly used.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between 20 and 45 years
  • Previous 1-3 cesarean sections
  • The duration from the last cesarean section ranging from 6 months to 5 years.

排除标准

  • Pregnancy (Positive pregnancy test)
  • Recent pelvic infection.
  • Active pelvic infection.
  • Recent surgery on the tubes or the uterus.
  • Active vaginal bleeding.
  • Menstruation.
  • Suspected malignancy.
  • Intrauterine device in situ.

结局指标

主要结局

Diagnostic Accuracy of Cesarean Scar Defect Assessment Using 3D TVS

时间窗: Intraoperatively

This outcome measure aims to evaluate the diagnostic accuracy of three-dimensional transvaginal ultrasound (3D TVS) as measurement tools in assessing Cesarean Scar Defects (CSD) and associated complications among symptomatic patients with a history of cesarean section. The assessment will involve identifying, classifying, and measuring Cesarean Scar Defects (CSD) characteristics using these specific measurement techniques.

Diagnostic Accuracy of Cesarean Scar Defect Assessment Using Saline-Infused Sonography

时间窗: Intraoperatively

This outcome measure aims to evaluate the diagnostic accuracy of saline-infused sonography (Sonohystrography) as measurement tools in assessing Cesarean Scar Defects (CSD) and associated complications among symptomatic patients with a history of cesarean section. The assessment will involve identifying, classifying, and measuring Cesarean Scar Defects (CSD) characteristics using these specific measurement techniques.

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

Israa Bahaa Hassan Sherif

Resident of Obstetrics and Gynecology, Nile specialized Hospital, Egypt

Cairo University

研究点 (1)

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