Role of Rehabilitation for the Repair of Pelvic Floor Injuries Associated to Vaginal Delivery Identified by 3/4D Transperineal Ultrasound
- Conditions
- Pelvic Floor DisordersUltrasound Therapy; ComplicationsPhysical DisorderObstetric Labor Complications
- Interventions
- Other: Physiotherapy treatment
- Registration Number
- NCT03592160
- Lead Sponsor
- Hospital Universitario de Valme
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 52
- Vaginal delivery
- Cephalic presentation
- Primiparity
- At term gestation (37-42 weeks)
- No prior pelvic floor corrective surgery
- Written informed consent
- Pregnancies with severe maternal or fetal pathology
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Physiotherapy treatment The therapy lasted two months, at a rate of two sessions per week, with a duration of 45 minutes per session. The program consisted of pelvic floor exercises assisted by manometric biofeedback, which were performed in supine position for 20 minutes. In addition, active lumbopelvic stabilization exercises, including the contraction of pelvic floor muscles was performed in supine, plank and quadruped position. Together with the treatment at the clinic, patients were asked to perform a series of exercises at home, consisting in: 8-12 sustained contractions of 6 seconds, with a subsequent rest period of double the work-time, followed by 3-5 fast contractions of 2 seconds with maximum intensity, resting double the work-time. Domiciliary exercises were performed in supine, siting and standing position.
- Primary Outcome Measures
Name Time Method Contractility 6 months after randomisation Assess the improvement in contractility / tone, evaluated by manometry, of the pelvic floor produced by the treatment of postpartum physiotherapy of the pelvic floor.
- Secondary Outcome Measures
Name Time Method Changes in the levator ani muscle 6 months after randomisation To estimate the ultrasonographic changes in the levator ani muscle after rehabilitation, determining the maximum thicknesses and levator ani muscle area.
Trial Locations
- Locations (1)
Hospital Nuestra Señora de Valme
🇪🇸Sevilla, Spain