跳至主要内容
临床试验/NCT05096910
NCT05096910Unknown不适用

COSMOSS Study, Comparison Of Suture Materials on Sectio Scars. A Multicenter Prospective Randomized Controlled Study

Uludag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月4日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Isthmocele Rate

研究概览

简要总结

This multicenter prospective randomized controlled trial aims to investigate the ishtmocele rates after c-section delivery depending on using different suture materials for the uterine closure.

详细描述

The study involves 5 health centers (two universities, three private hospitals). Patients who will undergo their first cesarean section because of any etiology (except emergent cases) will be included in the study. Operation Nurse will randomize the patients into two groups depending on the monofilament or poly filament suture material. Patients will be checked by transvaginal ultrasound on a postoperative day one, postoperative first month, and postoperative sixth month. As the primary result, the istmocele rates will be compared between the study groups.

研究设计

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

入排标准

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

入选标准

  • 18-40 yrs women
  • Primary elective cesarean section
  • First delivery
  • Without any systemic diseases

排除标准

  • emergent delivery
  • previous c-section history
  • congenital uterine abnormality

结局指标

主要结局

Isthmocele Rate

时间窗: 6 months

diagnosis of isthmocele during 6th month ultrasound check.

次要结局

未报告次要终点

研究者

发起方
Uludag University
申办方类型
Other
责任方
Principal Investigator
主要研究者

GÜRKAN UNCU,PROF. MD

M.D, Professor

Uludag University

研究点 (1)

Loading locations...

相似试验