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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
194
Application of BabySlide during vacuum-assisted births for perineal protection
University Hospital Zurich
Zurich, Switzerland
rate of vaginal tears
assessment of the rate of vaginal tears in the posterior compartment by inspection
Time frame: at day of birth
rate of low-grade perineal tears
assessment of the rate of low-grade perineal tears by inspection
Time frame: at day of birth
rate of high-grade perineal tears
assessment of the rate of high-grade perineal tears by inspection
Time frame: at day of birth
Maternal adverse effects
assessment of maternal adverse effects of the BabySlide by medical staff
Time frame: within 1-4 days after birth
Fetal adverse effects
assessment of fetal adverse effects of the BabySlide by medical staff
Time frame: within 1-4 days after birth
Maternal comfort with the BabySlide
Assessment of maternal comfort with the BabySlide by a questionnaire
Time frame: within 1-4 days after birth
User abilitiy
Assessment of the user ability of the BabySlide by a questionnaire
Time frame: directly after the procedure
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