Can Ultrasound Predict Labor Outcome in Operative Vaginal Deliveries?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- Time from start of vacuum assisted traction to delivery
研究概览
简要总结
To assess whether ultrasound methods can predict outcome of operative vaginal deliveries in nulliparous women at term with singleton pregnancies and prolonged second stage of labor.
To compare different ultrasound assessments Compare digital assessments and ultrasound findings. Investigate if movement of the fetal head during active pushing is a predictive factor
Null hypotheses:
- Ultrasound measurements cannot predict outcomes of operative vaginal delivery.
- Ultrasound is not better than digital examination in predicting delivery outcome.
- Movement of fetal head with active pushing is not a predictive factor.
详细描述
The physician responsible for the labor will perform digital examinations (fetal station and position and cervical dilatation). Fetal station will be related to the ischial spine from -5 to +4 as described by WHO and illustrated in Figure 111. Another obstetrician or midwife blinded to the results from the clinical examination will perform the ultrasound measurements. The physician responsible for the labor will be blinded to the ultrasound measurements.
Ultrasound examinations between contractions
Due to considerations described below, only one recording/acquisition will be performed of each of the following:
A) Head position B) Head-perineum distance C) Midline angle D) Angle of progression E) 3D sagittal transperineal acquisition In addition single scans are performed during active pushing as described under B) and D) (and a 3D sagittal scan when possible).
A) Head position Position will be assessed in 2D with a transabdominal scan as described by Akmal4 and 3D in a transperineal scan as described by Ghi et al22. Fetal head position will be recorded as a clock dividing the circle in 24 divisions
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
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •prolonged second stage of labour
排除标准
- •Suspected asphyxia before the start of vacuum extraction
结局指标
主要结局
Time from start of vacuum assisted traction to delivery
时间窗: Active second stage of labor to1 hour after delivery
The duration of a vacuum extraction will be measured. Therefore, the time frame is for this variable is only the second stage of labor. However, the time frame including all variables will be from the start of active second stage of labor - 1 hour after delivery.
次要结局
- Successful/failed vaginal operative delivery (vaginal delivery vs. cesarean section(Active second stage of labour)