Ignite Creation Date:
2025-12-18 @ 9:19 AM
Ignite Modification Date:
2025-12-23 @ 6:12 PM
Study NCT ID:
NCT04370340
Status:
None
Last Update Posted:
2022-11-02 00:00:00
First Post:
2020-04-21 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of a Perineal Protection Device in Vacuum-assisted Births
Sponsor:
None
Organization:
Study Overview
Official Title:
Application of a Perineal Protection Device in Vacuum-assisted Births: a Prospective Randomized Controlled Trial
Status:
None
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: