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临床试验/NCT06475924
NCT06475924已完成不适用

Relation Between Position of the Uterus (Anteversion or Retroversion Flexion) and Degree of Cesarean Scar Niche : Cross -Sectional Study

Ain Shams University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2023年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
correlation between position of the uterus and large Cesarean Scar defect (CSD)

研究概览

简要总结

This study aims to determine the association between the size of caesarean scar niche and uterine position in childbearing women.

Research hypothesis: There is a relation between uterine position and degree of cesarean scar niche.

Research question: Is there a relation between uterine position and degree of cesarean scar niche?

详细描述

It has been noted that the cesarean scar defect in patients with retroflexed uteri appear to be larger than are those in patients with anteverted uteri.

This study will describe the association between position of the uterus whether share in degree of cesarean scar niche or not and associated symptoms.

Primary outcome:

The association between the position of the uterus (Anteverted/Retroverted) and large CSD (the ratio between the depth and adjacent myometrial thickness)

Secondary outcomes:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women in childbearing age.
  • At least six months postpartum.
  • With cesarean scar niche/defect (CSD) by transvaginal ultrasound that is defined as "indentation at the site in the cesarean section scar with a depth of at least 2 mm" that was agreed upon in 2019 by a European task force

排除标准

  • Severely Obese (Body mass index; BMI more than or equal to 35 kg/m2).
  • Women with abnormal uterine pathology, observed during the ultrasound examination that may have been responsible for abnormal uterine bleeding, including endometrial hyperplasia, polyps, malignancy or myomas.
  • Women with any cause of pelvic pain as pelvic inflammatory diseases, endometriosis or adenomyosis.
  • Women with history of classic upper segment cesarean section or hysterotomy.
  • Women with history of previous uterine scars rather than cesarean sections as myomectomy.
  • Women with bleeding tendency disorders, taking anticoagulants or having chronic medical conditions as liver diseases, or coagulopathies.

结局指标

主要结局

correlation between position of the uterus and large Cesarean Scar defect (CSD)

时间窗: through study completion, up to 6 months

By using transvaginal ultrasound, the uterus will be examined in a mid sagittal plane to evaluate the position of the uterus that will be described as (Anteverted: the uterus tilts forward at the cervix/ Retroverted: the uterus tilts backward at the cervix), which will be correlated to the presence of Large CSD (ratio between the depth (mm) and adjacent myometrial thickness (mm) more than or equal to 0.50)

次要结局

  • correlation between position of uterus and postmenstrual spotting(through study completion, up to 6 months)
  • correlation between position of uterus and Pelvic Pain(through study completion, up to 6 months)
  • correlation between position of uterus and Residual myometrial thickness(through study completion, up to 6 months)
  • correlation between position of uterus and Depth, Length, Width of SCD(through study completion, up to 6 months)
  • correlation between position of uterus and Abnormal Uterine Bleeding (AUB)(through study completion, up to 6 months)
  • correlation between position of uterus and secondary infertility(through study completion, up to 6 months)

研究者

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

Maya Abdelrazek

dr_maya89@med.asu.edu.eg

Ain Shams University

研究点 (1)

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