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Completed

NCT Number: NCT04370340

Application of a Perineal Protection Device in Vacuum-assisted Births

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.

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Key information

Conditions

Vaginal Tear Perineal Tear

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

BabySlide

Device

Application of BabySlide during vacuum-assisted births for perineal protection

Primary outcomes

  1. rate of vaginal tears

    Time frame: at day of birth

    assessment of the rate of vaginal tears in the posterior compartment by inspection

  2. rate of low-grade perineal tears

    Time frame: at day of birth

    assessment of the rate of low-grade perineal tears by inspection

Secondary outcomes

  1. rate of high-grade perineal tears

    Time frame: at day of birth

    assessment of the rate of high-grade perineal tears by inspection

  2. Maternal adverse effects

    Time frame: within 1-4 days after birth

    assessment of maternal adverse effects of the BabySlide by medical staff

  3. Fetal adverse effects

    Time frame: within 1-4 days after birth

    assessment of fetal adverse effects of the BabySlide by medical staff

  4. Maternal comfort with the BabySlide

    Time frame: within 1-4 days after birth

    Assessment of maternal comfort with the BabySlide by a questionnaire

  5. User abilitiy

    Time frame: directly after the procedure

    Assessment of the user ability of the BabySlide by a questionnaire

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 30, 2020
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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