Role of Intrapartum Ultrasound in the Efficacy of an Instrumental Delivery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Maternal and neonatal morbidity
研究概览
简要总结
Investigators will perform a multicentric randomized controlled trial comparing the effect of transabdominal and transperineal ultrasound in pregnant women in the second stage of labor, in whom it was decided an operative delivery. Our objective is to evaluate the impact of intrapartal ultrasound measurements, as an auxiliary to clinical evaluation, in the efficacy of an instrumental delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women at term, in labor (≥ 37 weeks of gestation dated by a first trimester ultrasound
- •live singleton pregnancy
- •fetus in a cephalic presentation
- •in the second stage of labor, after the decision to perform an instrumental delivery
排除标准
- •fetal malformations
- •emergency situation
研究组 & 干预措施
Study group
The study group will be constituted by pregnant women in whom the operative delivery will be preceded by a transabdominal and transperineal ultrasound to evaluate fetal head position and fetal head station, by means of determination of the 'angle of progression'.
干预措施: Transabdominal and transperineal ultrasound (Other)
Control group
The control group will be constituted by pregnant women in whom the operative delivery will be carried out based solely on clinical criteria, namely transvaginal digital examination.
结局指标
主要结局
Maternal and neonatal morbidity
时间窗: 2 years
Severe postpartum hemorrhage, perineal trauma, prolonged hospital stay
Neonatal morbidity
时间窗: 2 years
low 5-minute Apgar score, umbilical artery metabolic acidosis, birth trauma and neonatal intensive care unit admission
次要结局
未报告次要终点