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Clinical Trial Summary

The purpose of this study is to determine whether a modified perineum protection device can reduce tearing during delivery.


Clinical Trial Description

RCT investigation using a modified device during delivery of the baby's head (an earlier model has proved successful) and assess whether the use can decrease delivery tears as measured in length. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT02013752
Study type Interventional
Source Helsingborgs Hospital
Contact Knut Haadem, M.D. PhD
Phone 0046739549946
Email knut.haadem@telia.se
Status Recruiting
Phase Phase 2/Phase 3
Start date March 2015
Completion date December 2015