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临床试验/NCT07074522
NCT07074522已完成不适用

Transvaginal Ultrasound Assessment of Caesarean Section Uterine Scar Closed by Single Versus Double Layer

Tanta University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Uterine scar thickness

研究概览

简要总结

This study aimed to evaluate uterine scar thickness and integrity using transvaginal ultrasonography in women randomly assigned to single versus double-layer closure of the uterine incision, with a comparison between the two groups.

详细描述

Cesarean section (CS) is one of the most commonly performed major abdominal operations in women in both high and low-income countries.

Single-layer closure using a running locking stitch is associated with decreased operative time and fewer additional haemostasis sutures. An extensive Canadian study found a fourfold increase in the risk of uterine rupture in a woman who had a single layer in their previous pregnancy.

Transvaginal ultrasound is a validated tool for evaluating uterine scar defects, commonly referred to as a niche. It is used to asses the uterine scar thickness in a women with previous cesarean delivery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Age from 20 to 40 years old.
  • •Pregnant women underwent their first cesarean section.

排除标准

  • •Body mass index (BMI) ≥ 30 kg /m
  • •Multiple gestations.
  • •Uterine malformation.
  • •Placenta previa.
  • •Placenta accreta.
  • •Uterine or cervical fibroid.
  • •Any previous uterine operation or any medical disease that compromises wound healing, such as diabetes mellitus, collagen diseases, anemia, or corticosteroid therapy.

研究组 & 干预措施

Single layer group

Experimental

Patients who underwent single-layer closure of the transverse lower segment during cesarean section.

干预措施: Single-layer closure (Procedure)

Double layer group

Experimental

Patients who underwent double-layer closure of the transverse lower segment during cesarean section.

干预措施: Double-layer closure (Procedure)

结局指标

主要结局

Uterine scar thickness

时间窗: 6 months postoperatively

Uterine scar thickness was evaluated by transvaginal ultrasound six weeks, three months, and six months postoperative.

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

Said Abd El Kareem Said Saad

Resident of Obstetrics and Gynecology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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