Application of a Perineal Protection Device in Vacuum-assisted Births

Perineal Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04370340
• Other study ID #: PeriProtectTrial
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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®

Related Conditions & MeSH terms

• Perineal Tear
• Vaginal Tear

Intervention

Device:
• BabySlide
Application of BabySlide during vacuum-assisted births for perineal protection

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of vaginal tears	assessment of the rate of vaginal tears in the posterior compartment by inspection	at day of birth
Primary	rate of low-grade perineal tears	assessment of the rate of low-grade perineal tears by inspection	at day of birth
Secondary	rate of high-grade perineal tears	assessment of the rate of high-grade perineal tears by inspection	at day of birth
Secondary	Maternal adverse effects	assessment of maternal adverse effects of the BabySlide by medical staff	within 1-4 days after birth
Secondary	Fetal adverse effects	assessment of fetal adverse effects of the BabySlide by medical staff	within 1-4 days after birth
Secondary	Maternal comfort with the BabySlide	Assessment of maternal comfort with the BabySlide by a questionnaire	within 1-4 days after birth
Secondary	User abilitiy	Assessment of the user ability of the BabySlide by a questionnaire	directly after the procedure