질분만 후 회음부 열개 여성의 보존적 치료 또는 재수술 (HEAL)
질 분만 후 열개 회음부 열상(HEAL) - 보존적 치료 또는 재건
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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Herlev, 덴마크, DK-2730
- Department of Obstetrics and Gynaecology, Copenhagen University Hospital - Herlev and Gentofte
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Body image
기간: 9-12 months
|
Measured by the Body-Image questionnaire FGSIS - Female Genital Self-Image Scale |
9-12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Wound healing
기간: 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
기간: One month
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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
기간: 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
기간: 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
기간: 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
기간: 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
|
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Re-admission
기간: 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
기간: 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
기간: 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
|
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Fecal incontinence
기간: 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)
기간: 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
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|
Pain intensity
기간: 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
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|
Consuming painkillers because of pain due to perineal tear
기간: 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
기간: One month and 9-12 months
|
Measured by Modified Oxford scale |
One month and 9-12 months
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Hanna M. Jangö, MD, PhD, Copenhagen University Hospital - Herlev and Gentofte
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- H-23022460
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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