Application of a Perineal Protection Device in Vacuum-assisted Births

NCT04370340 | Completed Phase 3

• 1 other identifier: PeriProtectTrial
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• rate of high-grade perineal tears

  at day of birth

• Maternal adverse effects

  within 1-4 days after birth

• Fetal adverse effects

  within 1-4 days after birth

• Maternal comfort with the BabySlide

  within 1-4 days after birth

• User abilitiy

  directly after the procedure

Study Arms (2)

control

NO INTERVENTION

intervention

ACTIVE COMPARATOR

Device: BabySlide

Interventions

BabySlide DEVICE

Application of BabySlide during vacuum-assisted births for perineal protection

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- 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®

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Study Officials

• Nina Kimmich, Dr.

  University Hospital Zurich, Department od Obstetrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 30, 2020
• Study Start: August 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-11

Locations

CH (1)