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临床试验/NCT03911622
NCT03911622Unknown不适用

Role of Magnetic Resonance Imaging in Evaluation of Uterine Cesarean Section Scar Niche

Assiut University0 个研究点目标入组 30 人开始时间: 2019年4月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
MRI pelvis examination (sagittal T2WI ) using 1.5 tesla system Torso phased-array body coil with the patient in the supine position and a moderately full urinary bladder

研究概览

简要总结

To evaluate cesarean section scar and the lower uterine segment in non pregnant woman by MRI to :

  1. Assess the clinical symptoms like postmenstrual spotting or prolonged menstrual bleeding, dysmenorrhea, chronic pelvic pain and dyspareunia and its relation to the presence of cesarean scar defects and its characteristics .
  2. development of scoring system and correlating it with the symptoms .

详细描述

With increasing cesarean section rate nowadays, the risks of cesarean scar defect (CSD) should increase. CSD is defined by ultrasound imaging as a triangular hypoechoic defect in the myometrium at the site of the previous cesarean section scar. However, patients with CSD are sometimes asymptomatic. Yet, some patients with CSD can have symptoms of abnormal uterine bleeding, pelvic pain, infertility, uterine rupture, and potential risks of adverse pregnancy outcome .There is an association between the size of a niche and postmenstrual spotting. women with a history of CS, the depth and shape of the niche were not significant factors, while a larger niche volume was described in women with postmenstrual spotting. in women with gynecological symptoms, the niches were significantly wider in women with postmenstrual spotting, dysmenorrhea or chronic pelvic pain, and the prevalence of postmenstrual spotting or prolonged menstrual bleeding was higher with a larger diameter of the niche .Magnetic resonance imaging (MRI) has recently shown a promise tool for evaluation of uterine scar thickness. As opposed to ultrasonography (USG), which is the current gold standard for this purpose, MRI reduces observer dependence and has a superior multiplanar capability.

MRI can be used for assessment of lower uterine segment. It provides accurate tissue characterization, independent of patient body mass index .

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • previous lower uterine segment cesarean section before .
  • At least 6 months after the last cesarean section .
  • still regularly menstruating .
  • Absence of other gynecological disease or intrauterine lesions like endometriosis , uterine fibroid .

排除标准

  • Post menopausal women .
  • hysterectomy .
  • Presence of other gynecological disease like endometriosis , uterine fibroids .
  • any general contraindication to MRI as presence of any paramagnetic substance as pacemakers or in severely ill patients or those with claustrophobia, arrhythmic patients .
  • intrauterine devices .
  • bleeding tendency.

结局指标

主要结局

MRI pelvis examination (sagittal T2WI ) using 1.5 tesla system Torso phased-array body coil with the patient in the supine position and a moderately full urinary bladder

时间窗: baseline

Scar shape were classified as "U" shape, "V" shape and mixed shape, judging from the transitional region from scar to normal uterine or cervical wal

次要结局

  • transabdominal and transvaginal ultrasound examination(baseline)
  • clinical evaluation(baseline)

研究者

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

Kero Wagdy

resident doctor

Assiut University

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Mri in Evaluation of Cesarean Section Scar Niche | 临床试验