Repair by Rehabilitation of Pelvic Floor Lesions After Vaginal Delivery Identified by Transperineal Ultrasound 3/4 D
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Changes in muscle thickness (millimeters) of the levator ani muscle
研究概览
简要总结
SUMMARY: (Objective, design, scope of the study, subjects of study, instrumentation, results, conclusions)
Objectives: To evaluate if the physiotherapy treatment in pelvic floor dysfunctions, identified by transperineal ultrasound 3 / 4D, in postpartum improve the tone and functionality of pelvic floor.
Design: Post-authorization, prospective, longitudinal randomized intervention study
Scope: Full-term deliveries at the University Hospital. Subjects of study: Full-term primiparous and full-term pregnancies with pelvic floor lesion, identified by transperineal ultrasound 3 / 4D, which are randomized between the physiotherapy treatment of pelvic floor and the non-work.
Variables: Primary variable: Assess the improvement in contractility / tone, evaluation by manometry and assess the anatomical improvement of the area of ?? the genital hiatus, stay by transperineal ultrasound 3 / 4D. Secondary variables: Identify the levator ani muscle injury rate, estimate the sonographic changes in the levator ani muscle through rehabilitation. Analyze the improvement of the symptoms associated with the public organic prolapse and evaluate the improvement of the quality of life.
Data analysis: To detect a difference of 10% in the reduction of the size of the index between the study groups (not intervened / intervened) after 6 months of intervention, standard deviation 10%, Error-alpha 5%, Error- beta 10% (P90%) we need 23 women in each group. Assuming a loss of 10% in the follow-up, the final size would be 52 women, 26 per group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Vaginal delivery
- •Cephalic presentation
- •Primiparity
- •At term gestation (37-42 weeks)
- •No prior pelvic floor corrective surgery
- •Written informed consent
排除标准
- •Pregnancies with severe maternal or fetal pathology
结局指标
主要结局
Changes in muscle thickness (millimeters) of the levator ani muscle
时间窗: 6 months after randomisation
Changes in muscle thickness (millimeters) of the levator ani muscle, measured with transperineal ultrasound 3-4D
To evaluate the changes in pressure in the contractility evaluated by manometry (mm Hg)
时间窗: 6 months after randomisation
To evaluate the changes in pressure in the contractility evaluated by manometry (mm Hg), of the medical floor produced by the treatment of postpartum physiotherapy of the pelvic floor
次要结局
未报告次要终点
研究者
José Antonio García Mejido
Dr.
Hospital Universitario de Valme
