临床试验/NCT02899481

NCT02899481终止不适用

Role of Intrapartum Ultrasound in the Efficacy of an Instrumental Delivery

University of Lisbon1 个研究点分布在 1 个国家目标入组 222 人开始时间: 2016年9月最近更新: 2020年6月23日

适应症

试验速览

阶段: 不适用
状态: 终止
发起方: University of Lisbon
入组人数: 222
试验地点: 1
主要终点: Maternal and neonatal morbidity

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

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

研究者

发起方

University of Lisbon

申办方类型

Other

责任方

Principal Investigator

主要研究者

Joana Barros

University of Lisbon

研究点 (1)

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