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临床试验/NCT01610453
NCT01610453已完成不适用

Prediction of Mode of Delivery With Transperineal Ultrasound in Women With Prolonged First Stage of Labour. A Multicentre Study

Helse Stavanger HF6 个研究点 分布在 4 个国家目标入组 150 人开始时间: 2012年1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
150
试验地点
6
主要终点
Percentage of Women With Vaginal Deliveries

研究概览

简要总结

Objectives

  1. To assess if head-perineum distance and angle of progression measured with transperineal ultrasound by the obstetrician on call can predict delivery mode in primiparous women with prolonged first stage of labour.
  2. To compare ultrasound assessments and clinical examinations.

详细描述

Variables Digitally assessed cervical dilatation, fetal station and position Ultrasound measured fetal head-perineum distance. Ultrasound measured angle of progression Ultrasound assessed position

Possible confounders Ethnicity, maternal age, gestational age, BMI, induction of labour, augmentation, epidural analgesia, birth weight, head circumference

A two-dimensional ultrasound measurement will be obtained with the ultrasound device available in the delivery department. Fetal head descent is measured as the shortest distance between the outer bony limit of the fetal skull and the perineum with a curved transabdominal transducer placed transperineally between the labia in a transverse view (1).

The fetal descent will also be assessed measuring "angle of progression" as suggested by Barbera et al. The ultrasound transducer will be placed on the perineum in a mid-sagittal position between the labia below the pubic symphysis. The angle between a line through the symphysis and a line from the posterior part of the symphysis tangentially to the fetal skull contour will be measured (2)

A transabdominal scan will also be performed determining the fetal position as described previously. Positions ≥ 02.30 and ≤ 03.30 hours should be recorded as left occiput transverse and positions ≥ 08.30 and ≤ 09.30 as right occiput transverse. Positions > 03.30 and <08.30 should be recorded as occiput posterior and positions > 09.30 and < 02.30 as occiput anterior.(3).

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
15 Years 至 48 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Primiparous women with single pregnancies and gestation age > 37 weeks and prolonged first stage of labor

排除标准

  • High risk pregnancies,
  • premature deliveries,
  • multiple pregnancies

结局指标

主要结局

Percentage of Women With Vaginal Deliveries

时间窗: active labor

Women were categorized in accordance to fetal descent measured by ultrasound. Head-perineum distance (HPD) ≤40 mm and angle of progression (AoP) ≥110 degrees were used as cut-off level. HPD was obtained in all 150 cases and AoP was successfully obtained in 145 cases.

次要结局

  • Percentage of Women With Cesarean Section(active labor)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (6)

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