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Clinical Trial Summary

The goal of this observational study is to make us more aware of the short and long-term outcomes for women having an uncomplicated healing process after a rupture or birth cut in the perineum after giving birth in relation to a healing process with a dehisced wound treated with conservative management or secondary suturing. Participants will be asked to do - A gynecological examination at one month after birth and 9-12 months after birth. - Have a picture taken of the healing process - Answer a questionnaire at one month, three months, and 9-12 months after birth


Clinical Trial Description

The best way to manage perineal wound dehiscence after childbirth is unknown. Currently, there is no agreed best practice recommendation for managing perineal wound dehiscence due to a lack of evidence comparing conservative management with secondary suturing. Therefore, studies are urgently needed to compare the benefits and risks of both treatments. This study has the potential to significantly impact women´s health for those suffering from perineal wound dehiscence. The investigators want to include 100 women who have had a primary repair of a second-degree tear or episiotomy with a normal/uncomplicated healing process, 100 women with a second-degree tear or episiotomy identified with a dehisced wound treated with secondary resuturing, and 100 women with a second-degree tear or episiotomy identified with a dehisced wound treated with conservative management. All women who meet the inclusion criteria are recommended the same treatment and follow-up as currently present as standard care at the four hospitals that the investigators are recruiting from. The study deviates from the standard of care by offering two extra clinical examinations, one questionnaire evaluation without clinical examination, and a follow-up with pictures of the perineal tear healing process. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06026423
Study type Observational
Source Herlev Hospital
Contact Lærke V. Moestrup, PhD student
Phone +45 21351767
Email laerke.vinberg.moestrup@regionh.dk
Status Recruiting
Phase
Start date September 15, 2023
Completion date September 1, 2026