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临床试验/NCT03686956
NCT03686956已完成不适用

Repair by Rehabilitation of Pelvic Floor Lesions After Vaginal Delivery Identified by Transperineal Ultrasound 3/4 D

Hospital Universitario de Valme2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2018年8月1日最近更新:
适应症

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

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

发起方
Hospital Universitario de Valme
申办方类型
Other
责任方
Principal Investigator
主要研究者

José Antonio García Mejido

Dr.

Hospital Universitario de Valme

研究点 (2)

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