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

NCT ID: NCT03592160

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2016-09-30

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.

Conditions

Pelvic Floor Disorders; Ultrasound Therapy; Complications; Physical Disorder; Obstetric Labor Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

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.

Group Type: EXPERIMENTAL

Physiotherapy treatment

Intervention Type: OTHER

Physiotherapy treatment consisted of pelvic floor exercises assisted by manometric biofeedback. In addition, active lumbopelvic stabilization exercises, including the contraction of pelvic floor muscles was performed in supine, plank and quadruped position.

Control group

The control group received an information brochure with recommendations, including the same program of pelvic floor exercises taught to the patients in the experimental group, but without carrying out any kind of supervision by the physiotherapist.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physiotherapy treatment

Physiotherapy treatment consisted of pelvic floor exercises assisted by manometric biofeedback. In addition, active lumbopelvic stabilization exercises, including the contraction of pelvic floor muscles was performed in supine, plank and quadruped position.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Hospital Universitario de Valme

OTHER

Sponsor Role: lead

Responsible Party

José Antonio García Mejido

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José Antonio García Mejido

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Nuestra Señora de Valme

Locations

Hospital Nuestra Señora de Valme

Seville, , Spain

Countries

Spain

Other Identifiers

Rehabilitación avulsion

Identifier Type: -

Identifier Source: org_study_id