Treatment of Scarring and Dysfunction of the Pelvic Floor in Postpartum, Through Physical Therapy or by Medical Recommendations in Consultation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- change in VAS from the start to the end
研究概览
简要总结
Recruitment of patients who have suffered third- and fourth-degree perineal tear during childbirth, and who have given birth at the Hospital Universitario Marqués de Valdecilla (Santander, Spain). They are distributed randomly in two groups an experimental group who apply techniques of physiotherapy and a control group, receiving medical treatment.
At the same time is recruited the same number of patients who have not suffered tear and whose birth has been instrumental, dividing into two groups, control and experimental. And the same number of patients who have given birth but have not suffered tear or instrumental delivery, divided also into control group and experimental.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who have dysfunctions in the pelvic floor after childbirth
- •Patients who have given birth at the Hospital Universitario Marqués de Valdecilla
- •Patients who do not have any medical alteration that does not indicate the treatment
排除标准
- •Patients who do not have pelvic floor dysfunctions after childbirth
- •Patients who have not given birth at the Hospital Universitario Marqués de Valdecilla
- •Patients who have any medical changes that counter the treatment
结局指标
主要结局
change in VAS from the start to the end
时间窗: in the begining, at thirth month, at sixth month and at the finish (one year later)
Pain
Change in SF36 from de start to the end
时间窗: in the begining, at thirth month, at sixth month and at the finish (one year later)
quality of life sorth form
Change in EPIQ from de start to the end
时间窗: in the begining, at thirth month, at sixth month and at the finish (one year later)
Epidemiology of Prolapse and Incontinence Questionnaire
Change in OXFORD from the start to the end
时间窗: in the begining, at thirth month, at sixth month and at the finish (one year later)
muscle strength
次要结局
未报告次要终点
研究者
MARÍA DEL PILAR VIDALES COLINAS
Principal Investigator
Universidad de León