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Spots Global Cancer Trial Database for Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour

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Trial Identification

Brief Title: Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour

Official Title: Dehisced Perineal Tear After Vaginal Labour (HEAL) - Conservative Treatment or Resuturing

Study ID: NCT06026423

Study Description

Brief 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

Detailed 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Department of Obstetrics and Gynaecology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, , Denmark

Contact Details

Name: Hanna M. Jangö, MD, PhD

Affiliation: Copenhagen University Hospital - Herlev and Gentofte

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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