NCT02326077暂停不适用
Intrapartum Ultrasonography - Sonopartogram. Longitudinal Evaluation of the Mechanism of Active Labor Using Ultrasound Parameters
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
- 是
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
研究点 (2)
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