Application of a Perineal Protection Device in Vacuum-assisted Births

Phase 3

Completed

• Conditions: Vaginal Tear; Perineal Tear
• Interventions: Device: BabySlide

• Registration Number: NCT04370340
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-04-30
• Study Start: 2020-08-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 194

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®

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	BabySlide	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
rate of high-grade perineal tears	at day of birth	assessment of the rate of high-grade perineal tears by inspection
Fetal adverse effects	within 1-4 days after birth	assessment of fetal adverse effects of the BabySlide by medical staff
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
User abilitiy	directly after the procedure	Assessment of the user ability of the BabySlide by a questionnaire

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland