Dehisced Perineal Tear After Vaginal Labour (HEAL) - Conservative Treatment or Resuturing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 2
- 主要终点
- Body image
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •None, first, third- and fourth-degree tear
- •Cesarean Section
研究组 & 干预措施
Normal/uncomplicated healing process
100 women with a second-degree tear or episiotomy primarily sutured after labor: identified with a normal/uncomplicated healing process
干预措施: Clinical examination and pictures (Other)
Normal/uncomplicated healing process
100 women with a second-degree tear or episiotomy primarily sutured after labor: identified with a normal/uncomplicated healing process
干预措施: Questionnaire (Other)
Dehisced wound treated with secondary resuturing
100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with secondary resuturing
干预措施: Clinical examination and pictures (Other)
Dehisced wound treated with secondary resuturing
100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with secondary resuturing
干预措施: Questionnaire (Other)
Dehisced wound treated with conservative management
100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with conservative management
干预措施: Clinical examination and pictures (Other)
Dehisced wound treated with conservative management
100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with conservative management
干预措施: Questionnaire (Other)
结局指标
主要结局
Body image
时间窗: 9-12 months
Measured by the Body-Image questionnaire FGSIS - Female Genital Self-Image Scale
次要结局
- Pain intensity(One month, three months, and 9-12 months)
- Prolapse(One month, three months, and 9-12 months)
- Urinary incontinence(One month, three months, and 9-12 months)
- Psychological well-being (maternal anxiety or depression)(Three months, and 9-12 months)
- Wound healing(One month)
- Re-admission(Within one month)
- Infection rate(One month)
- Dyspareunia(One month, three months, and 9-12months)
- Woman´s satisfaction with the aesthetic results of the perineal wound(One month, three months, and 9-12 months)
- Resuming sexual intercourse(One month, three months, and 9-12 months)
- Affected breastfeeding(One month, three months, and 9-12 months)
- Fecal incontinence(One month, three months, and 9-12 months)
- Pelvic floor muscle contraction(One month and 9-12 months)
- Consuming painkillers because of pain due to perineal tear(One month, three months, and 9-12 months)
研究者
Hanna Jangö
Staff specialist, Ph.D., Associated professor
Herlev Hospital