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临床试验/NCT03071783
NCT03071783已完成不适用

Intra-operative Feed Back on Traction Force During Vacuum Extraction: a Randomized Control Study of Mid and Low Metal Cup Deliveries.

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
800
试验地点
2
主要终点
Composite neonatal brain damage

研究概览

简要总结

The objective of the clinical investigation is to test whether intra-operative traction force feed back during vacuum extraction leads to a significant decrease in incidence of brain damage in neonates.

By randomization, half of the vacuum extraction patients will be assigned to delivery using a new intelligent handle for vacuum extractions, and half will be assigned to conventional method without traction force measurement.

详细描述

The most common indications for vacuum extraction are dystocia and/or fetal asphyxia. The safety of assisted vaginal delivery with vacuum extraction has been discussed since its introduction almost fifty years ago. Serious complications such as asphyxia, intracranial hemorrhage and seizures are overrepresented at vacuum extraction compared to spontaneous vaginal delivery.

Little has been done to improve the procedure since the introduction. Safety measures recommended include restricting total time and number of pulls, a full 34 week gestation, and station of the head at the spines or below. A general advice is also to avoid excessive traction force. There is no general agreement to what a safe traction force might be. With exceeding force there seems to be an increased risk for rupture of the sagittal sinus and tearing of the falx at its attachment to the tentorium. Furthermore, when the fetal head is becoming exceedingly elongated and flattened, and as the cup pops off it might cause damage to the brain and blood vessels.

During the procedure the obstetrician is under significant stress and the subjective element of the evaluation of traction force is a concern. The difficult decision of whether to continue a heavy extraction or abort the operation is made under stressful conditions and based mostly on subjective impressions.

To provide the obstetrician with more objective information, the investigators developed a new device consisting of an intelligent handle hooked to the chain of a regular metal cup.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Medical or social reasons for vacuum extraction with a metal cup, gestational age ≥37+0 weeks, singleton, cephalic

排除标准

  • Multiple pregnancy, breech presentation, gestational age <37+0

研究组 & 干预措施

Vacuum extraction intelligent system

Experimental

Measurement and intra-operative feed back of vacuum extraction data: notification signal based an algorithm calculation using traction force (peak and time force integral) and time.

干预措施: Vacuum extraction intelligent system (Device)

conventional

No Intervention

conventional handle

结局指标

主要结局

Composite neonatal brain damage

时间窗: From start of extraction through 28 days after delivery (or until discharge from the hospital)

Composite consists of: Hypoxic ischemic encephalopathy (HIE), intracranial hemorrhage (ICH), seizures, perinatal mortality and subgaleal hematoma as routinely diagnosed in patient chart

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Magnus Westgren

Professor

Karolinska Institutet

研究点 (2)

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