Application of a Perineal Protection Device in Vacuum-assisted Births

Study Overview
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Brief Summary
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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.

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

Conditions
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Vaginal Tear, Perineal Tear

Intervention / Treatment
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* Device: BabySlide


Participation Criteria
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Eligibility Criteria
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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®

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |