跳至主要内容
临床试验/NCT02326077
NCT02326077暂停不适用

Intrapartum Ultrasonography - Sonopartogram. Longitudinal Evaluation of the Mechanism of Active Labor Using Ultrasound Parameters

University of Medicine and Pharmacy Craiova2 个研究点 分布在 2 个国家目标入组 4,000 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
4,000
试验地点
2
主要终点
Sonopartogram. Longitudinal assessment of the mechanism of labor using ultrasound parameters.

研究概览

简要总结

Objectives:

  • Evaluation of the correlation between the sonographic parameter and clinical findings (e.g. digital examination) in any cephalic (not only occipital anterior) position
  • Examination of the relationship between various sonographic parameters
  • Determination of intraobserver and interobserver variation in obtaining the sonographic measurements
  • Analysis of the temporal variation of the different sonographic measurements in normal spontaneous vaginal delivery versus obstructed labor in fetuses with occiput anterior versus those with persistent occiput posterior
  • Establishment of a sonopartogram that should replace in an objective way Friedmann
  • Establishment of cut-off values that may help clinicians to choose between vaginal operative delivery or caesarean section
  • Another interesting aspect of intrapartum transperineal ultrasound imaging is whether there is a psychological benefit to the patient in being able to follow on the ultrasound screen how fetal head descent and position are being assessed objectively.

详细描述

Objectives:

  • Evaluation of the correlation between the sonographic parameter and clinical findings (e.g. digital examination) in any cephalic (not only occipital anterior)
  • Examination of the relationship between various sonographic parameters
  • Determination of intraobserver and interobserver variation in obtaining the sonographic measurements
  • Analysis of the temporal variation of the different sonographic measurements in normal spontaneous vaginal delivery versus obstructed labor in fetuses with occiput anterior versus those with persistent occiput posterior
  • Establishment of a sonopartogram that should replace in an objective way Friedmann
  • Determination of cut-off values that may help clinicians to choose between vaginal operative delivery or caesarean section
  • Investigation whether there is a psychological benefit to the patient in being able to follow on the ultrasound screen how fetal head descent and position are being assessed objectively.

Methods:

Unselected population Personal characteristics: GA, BMI, age, gesta, para Gestational age of more than 37 completed weeks dated by first- and/or mid-trimester scan.

Each patient provide informed consent before the ultrasound measurements. Transperineal ultrasound imaging and digital examinations in laboring patients with a singleton fetus in cephalic/pelvic presentation. Patients examined in their labor rooms.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • active labor
  • singleton pregnancy
  • eutrophic fetus
  • cephalic presentation

排除标准

  • indication for elective caesarean section
  • non-cephalic presentation
  • prior caesarean delivery
  • fetal hypotrophy or macrosomy
  • multiple pregnancies

结局指标

主要结局

Sonopartogram. Longitudinal assessment of the mechanism of labor using ultrasound parameters.

时间窗: 5 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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