Application of a Perineal Protection Device in Vacuum-assisted Births: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 2
- 主要终点
- rate of vaginal tears
研究概览
简要总结
Visible birth tears are common in vaginal births, especially in vacuum-assisted births. One aim of obstetrical work is to minimize such injuries by an adequate birth management , for example with a proper perineal support. The medical device "BabySlide®" was developed as an auxilliary device for perineal support and already evaluated in a multicenter randomized controlled trial in Schweden in pregnant women during vaginal birth. It could be seen, that the application of the device significantly reduced the rate of vagibal tears and low-grade perineal tearsin the intervention group (with application of the BabySlide®) in contrast to the controlo group (without application of the BabySlide®) by about 10%. In this study, solely 10% of births were ended by vacuum assistance. However, birth tears appear much more often in vacuum-assisted births than in normal spontaneous births. Therefore, the aim of this study is to evaluate the application of the device explicitly in vacuum-assisted births and to investigate if the application should be recommende in vacuum extractions in general in the future.
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
- 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
- 是
入选标准
- •Schwangere Frauen ab 18 Jahren
- •Schwangerschaftsalter ab 36+0 SSW bei Geburt
- •Einlingsschwangerschaft
- •Schädellage des Kindes bei Geburt
- •Anstreben einer Vaginalgeburt am USZ
- •Geburtsbeendigung per Vakuumextraktion (Saugglocke)
- •Schriftliche Einwilligung der teilnehmenden Person nach erfolgter Aufklärung (ausreichende Deutsch- bzw. Englischkenntnisse)
排除标准
- •- Geburtsbeendigung per Spontangeburt, Forcepsextraktion (Zange) oder Sectio caesarea (Kaiserschnitt)
- •Maternale Erkrankung des Bindegewebes (z.B. Kollagenosen)
- •Äusserliche fetale Fehlbildungen, die den Geburtsablauf und die Grössenverhältnisse von Kind zu Geburtskanal verändern
- •Intrauteriner Fruchttod des Kindes
- •Vaginale, perineale und/oder vulväre Voroperationen (ausser Naht von Geburtsverletzungen)
- •St.n. Beckenboden-Operation oder Inkontinenz-Operation
- •St.n. Infibulation
- •Anwendung des EPI-NO® Dammtrainers während der Schwangerschaft
- •Bekannte Allergien gegenüber einem der Inhaltsstoffe des BabySlide®
结局指标
主要结局
rate of vaginal tears
时间窗: at day of birth
assessment of the rate of vaginal tears in the posterior compartment by inspection
rate of low-grade perineal tears
时间窗: at day of birth
assessment of the rate of low-grade perineal tears by inspection
次要结局
- rate of high-grade perineal tears(at day of birth)
- Fetal adverse effects(within 1-4 days after birth)
- Maternal comfort with the BabySlide(within 1-4 days after birth)
- Maternal adverse effects(within 1-4 days after birth)
- User abilitiy(directly after the procedure)