First Stage 3D-ultrasound During Prolonged Labour.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound
研究概览
简要总结
This observational study is designed to correlate findings on ultrasound with manual palpation, and to consider if delivery outcome can be predicted with help of ultrasound. Specifically, the study will evaluate the significance of fetal head level (descent) in the pelvis, measured with ultrasound.
详细描述
AIM:
To correlate findings on ultrasound with manual palpation, and to consider if delivery outcome can be predicted with help of ultrasound. Specifically evaluate the significance of fetal head level (descent) in the pelvis, measured with ultrasound.
Objective:
Labours have traditionally been evaluated by manuals methods of the "delivery helper" - midwives or doctor. There are many factors that will prolong labour such as malcontractions, disproportion of the birth canal and malpresentation/position. In about 20% of primigravidae, the first stage will last longer than 10 hours.
In this study we want to evaluate different ultrasounds measurements to see if ultrasound can be used to predict the outcome of labour.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primi gravidae
- •>37th week
- •Cephalic presentation
- •Prolonged first stage according to WHO definitions.
排除标准
- •Multiple pregnancies
- •Intrauterine fetal death
结局指标
主要结局
Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound
时间窗: during labor
Fetal Head descent was first measured as the shortest distance between the outer bony limit of the fetal skull and the Perineum. Fetal head descent was re-assessed by measuring the angle of progression in a mid-sagittal plane. Fetal head-perineum distance was evaluated with using a cut-off of ≤40 mm, while the angle of progression was evaluated using a cut off of ≥ 110 degrees. The ROC curves plotted the percentage sensitivity against the percentage false positive rate for head-perineum distance and angle of progression as measured by ultrasound.
次要结局
- Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations)(6 hours post determination of prolonged labor)