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临床试验/NCT06466343
NCT06466343招募中不适用

Immunohistopathologic Findings of Cesarean Scar Niche

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
the incidence and type of different pathological variations within examined CS niche specimens.

研究概览

简要总结

Niche is iatrogenic pouch like defect, present on the uterine isthmus' anterior wall where a previous caesarean section scar was made. Still, a niche has generally been defined as the myometrium's depression of at least 2 mm (Lumbanraja et al., 2024).

The literature is lacking in information about the accurate histopathologic characteristics of cesarean scar niche ridges that have been removed by hysteroscopy, as well as what critical findings to highlight and what gynaecologists can anticipate from pathology reports of cesarean scar niche specimens (AbdullGaffar & Almulla ,2022).

In this study the aim of the work is to study the histopathologic findings in cesarean scar niche specimens repaired by hysteroscopy in our institution, identify the causes of local thinning of the uterine scar after c-section to direct gynecologists regarding the efficacy of their hysteroscopic corrective repair of cesarean scar niche concerning the amelioration of symptoms, restoration of fertility, and patient follow-up.

详细描述

Subjects & Methods Study will be conducted on non-pregnant women with symptomatic uterine scar niche after lower segment CS at Obstetrics and Gynecology department at Sohag University Hospitals.

Patient recruitment:

All eligible patients attending at the Obstetrics and Gynecology outpatient clinic at the department will be approached by the attending physician A through explanation about the nature of the study to each patient. All patients agreeing to participate in the study will be asked to sign the informed written consent before enrollment in the study.

Ultrasound examination:

Uterine scar niche will be diagnosed by transvaginal Logic P7, GE US (frequency 50/60Hz) postmenstrual. In longitudinal plane of the uterus at anterior wall at site of CS, the depth, width, and residual myometrial thickness will be measured. All measures will be done by single operator.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Any Women with history of previous CS once or more with period more than one year from the last CS and had CS scar defect diagnosed by TVUS.

排除标准

  • All women diagnosed with pelvic inflammatory disease, suspected with gynecological malignancy, postmenopausal women, women with heart disease, liver disease, renal impairment or bleeding tendency will be excluded from the study.

结局指标

主要结局

the incidence and type of different pathological variations within examined CS niche specimens.

时间窗: three weeks

measure the incidence and type of different pathological variations within examined CS niche specimens.

次要结局

  • correlation of predominant pathological variation with symptoms of patient and radiological findings.(2 weeks)

研究者

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

Mohamed Abdelnasser Galal

Assistant lecturer

Sohag University

研究点 (1)

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