Perineal Tear, Vaginal Tear
Conditions
Brief 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.
Interventions
DEVICEBabySlide
Application of BabySlide during vacuum-assisted births for perineal protection
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* \- 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®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of vaginal tears | at day of birth | assessment of the rate of vaginal tears in the posterior compartment by inspection |
| rate of low-grade perineal tears | at day of birth | assessment of the rate of low-grade perineal tears by inspection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fetal adverse effects | within 1-4 days after birth | assessment of fetal adverse effects of the BabySlide by medical staff |
| rate of high-grade perineal tears | at day of birth | assessment of the rate of high-grade perineal tears by inspection |
| User abilitiy | directly after the procedure | Assessment of the user ability of the BabySlide by a questionnaire |
| Maternal comfort with the BabySlide | within 1-4 days after birth | Assessment of maternal comfort with the BabySlide by a questionnaire |
| Maternal adverse effects | within 1-4 days after birth | assessment of maternal adverse effects of the BabySlide by medical staff |
Countries
Switzerland
Outcome results
None listed