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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | ||
| intervention | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BabySlide | Device | Application of BabySlide during vacuum-assisted births for perineal protection |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nina Kimmich, Dr. | University Hospital Zurich, Department od Obstetrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Zurich | 8091 | Switzerland |
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| 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 |