Application of a Perineal Protection Device in Vacuum-assisted Births

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

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.

Study Overview

• Status: Completed
• Conditions: Perineal Tear; Vaginal Tear
• Intervention / Treatment: Device: BabySlide

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Active Comparator: intervention	Device: BabySlide; Application of BabySlide during vacuum-assisted births for perineal protection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of vaginal tears	assessment of the rate of vaginal tears in the posterior compartment by inspection	at day of birth
rate of low-grade perineal tears	assessment of the rate of low-grade perineal tears by inspection	at day of birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of high-grade perineal tears	assessment of the rate of high-grade perineal tears by inspection	at day of birth
Maternal adverse effects	assessment of maternal adverse effects of the BabySlide by medical staff	within 1-4 days after birth
Fetal adverse effects	assessment of fetal adverse effects of the BabySlide by medical staff	within 1-4 days after birth
Maternal comfort with the BabySlide	Assessment of maternal comfort with the BabySlide by a questionnaire	within 1-4 days after birth
User abilitiy	Assessment of the user ability of the BabySlide by a questionnaire	directly after the procedure

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Nina Kimmich, Dr., University Hospital Zurich, Department od Obstetrics

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PeriProtectTrial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No