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Can Ultrasound Predict Labor Outcome in Operative Vaginal Deliveries?

2016年10月26日 更新者:Helse Stavanger HF

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.

研究概览

地位

完全的

详细说明

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

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.

Head-perineum distance will be assessed with transperineal ultrasound. The women will be examined lying flat (or almost flat) in bed with flexed hips and knees position. The bladder should be emptied immediately before the ultrasound examination.

Head-perineum distance will be measured as the shortest distance between the outer bony limit of the fetal skull and the perineum with a transabdominal transducer placed transperineally between the labia in a transverse view (posterior fourchette - posterior commissure of the labia minor)

Midline angle will be measured as described by Ghi22. In a transverse transperineal scan the angle between the midline of the fetal head and a sagittal line through the maternal pelvis will be measured. This recording will also be performed in a transverse scan.

Angle of progression will be measured as described by Barbera and Kalache as the angle between the long axis of the symphysis pubis and the tangent of the skull in a transperineal sagittal scan.

The following outcome variables will be recorded upon delivery Main outcome

  • Time from start of vacuum assisted traction to delivery (the entire body is delivered) Secondary outcomes
  • Number of contraction before delivery
  • Number of cup detachments
  • Successful/failed vaginal operative delivery
  • Forceps applied/not applied
  • Perineal tears
  • APGAR score of newborn.
  • Arterial umbilical cord blood pH and BD (base deficit) values.
  • Position at delivery

Statistics:

The time interval between start of operative vaginal delivery and delivery will be evaluated for the fetal head-perineum distance and angle of progression using survival analyses (Kaplan-Meier analyses and Cox regression analyses).

Categorical variables will be analyzed using Chi-square test and Fischer exact test, and continuous variable will be analyzed using T-test or Mann-Whitney U-test.

The predictive values for a successful operative vaginal delivery will be evaluated using receiver-operating characteristics (ROC) curves. The area under the curve (AUC, - 95% CI) is considered to have discriminatory potential if the lower limit of the CI exceeded 0.5.

Ultrasound measurements, digital assessment of station and dilatation, induction of labor, maternal age, gestational age and birth weight will be analyzed in logistic regression analyses with vaginal delivery vs. cesarean section as dependent variable.

研究类型

观察性的

注册 (实际的)

223

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Stavanger、挪威、4313
        • Stavanger University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

16年 至 45年 (孩子、成人)

接受健康志愿者

有资格学习的性别

女性

取样方法

概率样本

研究人群

Nulliparous women with a singleton live fetus in cephalic presentation at term (≥ 37 weeks) with prolonged active second stage and a clinical decision to expedite delivery by vacuum due to poor progression

描述

Inclusion Criteria:

  • prolonged second stage of labour

Exclusion Criteria:

  • Suspected asphyxia before the start of vacuum extraction

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
Women in active second stage of labour
Ultrasound examinations

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Time from start of vacuum assisted traction to delivery
大体时间: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.
Active second stage of labor to1 hour after delivery

次要结果测量

结果测量
措施说明
大体时间
Successful/failed vaginal operative delivery (vaginal delivery vs. cesarean section
大体时间:Active second stage of labour
Successful or failed operative deliveries will be recorded. The time frame is also for this variable only the second stage of labor.
Active second stage of labour

其他结果措施

结果测量
措施说明
大体时间
Apgar score
大体时间:first ten minutes after delivery
Apgar score is assessed after 1,5 and 10 minutes
first ten minutes after delivery
ph and base excess in umibical cord
大体时间:first 5 minutes after delivery
blood test from the umbilical board
first 5 minutes after delivery
birth weight and head circumference
大体时间:First hour after delivery
First hour after delivery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年11月1日

初级完成 (实际的)

2016年7月1日

研究完成 (实际的)

2016年7月1日

研究注册日期

首次提交

2013年6月9日

首先提交符合 QC 标准的

2013年6月14日

首次发布 (估计)

2013年6月17日

研究记录更新

最后更新发布 (估计)

2016年10月28日

上次提交的符合 QC 标准的更新

2016年10月26日

最后验证

2016年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2012/1865
  • 2012/186 (其他标识符:REK-VEST)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

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