Application of a Perineal Protection Device in Vacuum-assisted Births

University of Zurich (UZH)

Status and phase

Completed

Phase 3

Conditions

Vaginal Tear

Perineal Tear

Treatments

Device: BabySlide

Study type

Interventional

Funder types

Other

Identifiers

NCT04370340

PeriProtectTrial

Details and patient eligibility

About

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.

Enrollment

194 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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®