NCT04370340

Application of a Perineal Protection Device in Vacuum-assisted Births

Application of a Perineal Protection Device in Vacuum-assisted Births: a Prospective Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Vaginal Tear
• Perineal Tear

Interventions

Type	Name	Description
DEVICE	BabySlide	Application of BabySlide during vacuum-assisted births for perineal protection

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2020-04-30
• Last updated: 2022-11-02

Locations

1 site across 1 country: Switzerland