Traitement conservateur ou resuturation chez les femmes présentant une déhiscence de plaie périnéale après un travail vaginal (HEAL)
Déchirure périnéale déhiscée après un travail vaginal (HEAL) - Traitement conservateur ou resuturation
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
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Herlev, Danemark, DK-2730
- Department of Obstetrics and Gynaecology, Copenhagen University Hospital - Herlev and Gentofte
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
We want to include 100 women who have had a primary repair of a second-degree tear or episiotomy with an uncomplicated healing process. They will only be recruited from the Perineal Care Clinics at the Department of Obstetrics and Gynecology at the Copenhagen University Hospital - Herlev. Furthermore, we want to include 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. They will be recruited from the Perineal Care Clinics at the Department of Obstetrics and Gynecology at the Copenhagen University Hospitals - Rigshospitalet, Herlev Hospital, North Zealand Hospital, and Hvidovre Hospital. The women will come for a clinical examination to assess wound infection and healing 4 - 14 days post-partum.
La description
Inclusion Criteria:
- Women with a vaginal delivery who have had a primary repair of a second-degree perineal tear or episiotomy
- At least 18 years old
- Able to understand, read and speak Danish or English
- Able to give informed consent
Exclusion Criteria:
- None, first, third- and fourth-degree tear
- Cesarean Section
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Normal/uncomplicated healing process
100 women with a second-degree tear or episiotomy primarily sutured after labor: identified with a normal/uncomplicated healing process |
A clinical examination is needed to assess the healing process for the three groups. After assessing the healing process, we will take pictures of the tear for documentation. The participant will answer questions, serving as a baseline questionnaire, when arriving at the clinical examination one month post-partum. At three and 9-12 months post-postpartum, they will receive another questionnaire. The questionnaire will consist of validated questions regarding body image, pain, Urogynecological problems as symptoms of prolapse, urinary and anal incontinence, and questions about sexual problems. |
|
Dehisced wound treated with secondary resuturing
100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with secondary resuturing |
A clinical examination is needed to assess the healing process for the three groups. After assessing the healing process, we will take pictures of the tear for documentation. The participant will answer questions, serving as a baseline questionnaire, when arriving at the clinical examination one month post-partum. At three and 9-12 months post-postpartum, they will receive another questionnaire. The questionnaire will consist of validated questions regarding body image, pain, Urogynecological problems as symptoms of prolapse, urinary and anal incontinence, and questions about sexual problems. |
|
Dehisced wound treated with conservative management
100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with conservative management |
A clinical examination is needed to assess the healing process for the three groups. After assessing the healing process, we will take pictures of the tear for documentation. The participant will answer questions, serving as a baseline questionnaire, when arriving at the clinical examination one month post-partum. At three and 9-12 months post-postpartum, they will receive another questionnaire. The questionnaire will consist of validated questions regarding body image, pain, Urogynecological problems as symptoms of prolapse, urinary and anal incontinence, and questions about sexual problems. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Body image
Délai: 9-12 months
|
Measured by the Body-Image questionnaire FGSIS - Female Genital Self-Image Scale |
9-12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Wound healing
Délai: One month
|
The proportion of women with healed wounds at one month post-partum assessed by clinical examination and REEDA scale (Redness, Oedema, Ecchymosis, Discharge, Approximation of the wound edges). The REEDA scale contains five criteria each receiving a score between 0 and 3. The total score range from 0 - 15 with lower scores representing better-wound healing |
One month
|
|
Infection rate
Délai: One month
|
The proportion of women with an infected wound until one month post-partum assessed by clinical examination and measured by REEDA scale |
One month
|
|
Resuming sexual intercourse
Délai: One month, three months, and 9-12 months
|
Measured by the PISQ-12 questionnaire which is a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) |
One month, three months, and 9-12 months
|
|
Dyspareunia
Délai: One month, three months, and 9-12months
|
Measured by the PISQ-12 questionnaire which is a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) |
One month, three months, and 9-12months
|
|
Woman´s satisfaction with the aesthetic results of the perineal wound
Délai: One month, three months, and 9-12 months
|
Self-reported. The woman will be asked if she is satisfied with the aesthetic results of the perineal wound |
One month, three months, and 9-12 months
|
|
Affected breastfeeding
Délai: One month, three months, and 9-12 months
|
The woman will be asked whether she is breastfeeding or not |
One month, three months, and 9-12 months
|
|
Re-admission
Délai: Within one month
|
The women will be asked whether they have been readmitted to the hospital and why within four weeks p.p. |
Within one month
|
|
Prolapse
Délai: One month, three months, and 9-12 months
|
Measured by ICIQ-VS questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) |
One month, three months, and 9-12 months
|
|
Urinary incontinence
Délai: One month, three months, and 9-12 months
|
Measured by the ICIQ-UI SF questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) |
One month, three months, and 9-12 months
|
|
Fecal incontinence
Délai: One month, three months, and 9-12 months
|
Measured by ICIQ-B questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Bowel (ICIQ-B) |
One month, three months, and 9-12 months
|
|
Psychological well-being (maternal anxiety or depression)
Délai: Three months, and 9-12 months
|
Measured by Edinburgh Postnatal Depression Scale (EPDS). EPDS is a self-assessment questionnaire consisting of ten statements and the respondent is asked about their feelings over the last seven days. The answers are scored from 0-3 which gives an endpoint from 0-30. In Denmark, women are said to have depressive symptoms after delivery if they score 11 or higher |
Three months, and 9-12 months
|
|
Pain intensity
Délai: One month, three months, and 9-12 months
|
Self-reported pain intensity measured by Visual Analog Scale (VAS-score). Numeric rating scale from 0-10 (0 = no pain - 10 = pain as bad as can be) |
One month, three months, and 9-12 months
|
|
Consuming painkillers because of pain due to perineal tear
Délai: One month, three months, and 9-12 months
|
The participant will be asked whether she is consuming painkillers because of pain due to a perineal tear (Yes/No) |
One month, three months, and 9-12 months
|
|
Pelvic floor muscle contraction
Délai: One month and 9-12 months
|
Measured by Modified Oxford scale |
One month and 9-12 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Hanna M. Jangö, MD, PhD, Copenhagen University Hospital - Herlev and Gentofte
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Qualité des soins de santé, accès et évaluation
- Techniques d'investigation
- Méthodes épidémiologiques
- Thérapeutique
- Collecte de données
- Mécanismes d'évaluation des soins de santé
- Qualité des soins de santé
- Santé publique
- Environnement et santé publique
- Contrôle du comportement
- Immobilisation
- Enquêtes et questionnaires
- Retenue, physique
Autres numéros d'identification d'étude
- H-23022460
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .