Role of Rehabilitation for the Repair of Pelvic Floor Injuries Associated to Vaginal Delivery Identified by 3/4D Transperineal Ultrasound

Not Applicable

Completed

• Conditions: Pelvic Floor Disorders; Ultrasound Therapy; Complications; Physical Disorder; Obstetric Labor Complications

• 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

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-08-01
• Study Completion: 2016-09-30
• Status Verified: 2018-07
• Study First Submitted: 2018-07-05
• Study First Submitted QC: 2018-07-17
• Last Update Submitted: 2018-07-18
• Study First Posted: 2018-07-19
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

• Vaginal delivery
• Cephalic presentation
• Primiparity
• At term gestation (37-42 weeks)
• No prior pelvic floor corrective surgery
• Written informed consent

Exclusion Criteria

• Pregnancies with severe maternal or fetal pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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