Application of a Perineal Protection Device in Vacuum-assisted Births

NCT ID: NCT04370340

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-09-30

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.

Conditions

Vaginal Tear; Perineal Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

control

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention

Group Type: ACTIVE_COMPARATOR

BabySlide

Intervention Type: DEVICE

Application of BabySlide during vacuum-assisted births for perineal protection

Interventions

BabySlide

Application of BabySlide during vacuum-assisted births for perineal protection

Intervention Type: DEVICE

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®

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nina Kimmich, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Department od Obstetrics

Locations

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

PeriProtectTrial

Identifier Type: -

Identifier Source: org_study_id