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临床试验/NCT02827591
NCT02827591已完成不适用

Multimodale Beurteilung Der Stabilität Von Uterusnarbengewebe Bei Z.n. Sectio Caesarea

Martin-Luther-Universität Halle-Wittenberg1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
In vitro Ultrasonic Elastic Modulus versus in vitro tensile property measurements of LUS

研究概览

简要总结

This prospective, clinical, observational trial compares the measured value with quantitative ultrasonic (preoperatively) Elastic modulus E (kPA) with the measured value with quantitative ultrasonic Elastic modulus E (kPA) in vitro (postoperatively) and with the experimental measurement done in vitro (postoperatively) of lower uterine segment of women who underwent second cesarean section.

详细描述

In 1991, 126.297 (15.3%) women delivered by caesarean section in Germany. Since then, the rate of caesarean section increased steadily over the next 20 years, reaching up to 32.2% in 2011. The absolute risk of uterine rupture in vaginal birth after Caesarean section is 1 in 100 deliveries. The risk of perinatal death or the outcome of extremely neurological impairment is 1 in 1000 deliveries.

Statistically more than 300 pregnant women with a prior caesarean delivery visit daily ultrasound departments of german hospitals to investigate the C-section scar before delivery. They have one important question: Is it possible to predict successful trial of labor after cesarean delivery? The information for the risk of uterine rupture remains insufficient based only on ultrasonography assessment.

What are the possibilities of additional parameters to examine the stability of uterine scar tissue? Currently, there is no defined cut-off value of scar thickness for the prediction of uterine rupture. It remains questionable whether the thickness of the lower uterine segment is the determinant factor for the stability of the scar and the probability of rupture. However, another important factor is the functional elasticity or the structure of the connective tissue. It has not been further investigated until now (both quantitatively and qualitatively).

Objective of this project: Multimodalities of assessments, including ultrasonography and elastography, validate the accuracy of uterine scar stability in women with previous history of Caesarean section in vitro and in vivo.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnancy after previous cesarean section
  • pregnancy between 37 0/7 and 42 0/7 weeks of gestation
  • primary or secondary indication for cesarean section
  • ability to give informed consent in german or english

排除标准

  • emergency caesarean section
  • <18 years old

结局指标

主要结局

In vitro Ultrasonic Elastic Modulus versus in vitro tensile property measurements of LUS

时间窗: within 1 hour after Cesarean Section

The measured value of lower uterine segment with quantitative ultrasonic Elastic modulus E (kPA) in vitro versus the experimental tensile property measurements of lower uterine segment done in vitro. (Spearman's rank correlation coefficient)

次要结局

  • Difference - In vivo Ultrasonic Elastic Modulus versus in vitro tensile property measurements of LUS(within 1 hour after Cesarean Section)

研究者

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

Gregor Seliger

Dr. med., chief resident

Martin-Luther-Universität Halle-Wittenberg

研究点 (1)

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