Clinical trial NCT04370340: Application of a Perineal Protection Device in Vacuum-assisted Births
Official title: Application of a Perineal Protection Device in Vacuum-assisted Births: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaginal Tear
Perineal Tear
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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®

Primary outcomes:
measure: rate of vaginal tears
timeFrame: at day of birth
measure: rate of low-grade perineal tears
timeFrame: at day of birth
Secondary outcomes:
measure: rate of high-grade perineal tears
timeFrame: at day of birth
measure: Maternal adverse effects
timeFrame: within 1-4 days after birth
measure: Fetal adverse effects
timeFrame: within 1-4 days after birth
measure: Maternal comfort with the BabySlide
timeFrame: within 1-4 days after birth
measure: User abilitiy
timeFrame: directly after the procedure
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University Hospital Zurich, Department od Obstetrics
name: Nina Kimmich, Dr.
role: PRINCIPAL_INVESTIGATOR
References: