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

• ClinicalTrials.gov Identifier: NCT03592160
• Recruitment Status: Completed
• First Posted: July 19, 2018
• Last Update Posted: July 20, 2018
• Sponsor: Hospital Universitario de Valme
• Collaborator: Instituto de Salud Carlos III
• Information provided by (Responsible Party): José Antonio García Mejido, Hospital Universitario de Valme

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pelvic Floor Disorders; Ultrasound Therapy; Complications; Physical Disorder; Obstetric Labor Complications	Other: Physiotherapy treatment	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Role of Rehabilitation for the Repair of Pelvic Floor Injuries Associated to Vaginal Delivery Identified by 3/4D Transperineal Ultrasound
• Actual Study Start Date: January 1, 2016
• Actual Primary Completion Date: August 1, 2016
• Actual Study Completion Date: September 30, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: 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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures :

1. Contractility [ Time Frame: 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 :

1. Changes in the levator ani muscle [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Spain

Hospital Nuestra Señora de Valme

Sevilla, Spain, 41014

Sponsors and Collaborators

Hospital Universitario de Valme

Instituto de Salud Carlos III

Investigators

• Principal Investigator: José Antonio García Mejido; Hospital Universitario Nuestra Señora de Valme

More Information

• Responsible Party: José Antonio García Mejido, Principal Investigator, Hospital Universitario de Valme
• ClinicalTrials.gov Identifier: NCT03592160
• Other Study ID Numbers: Rehabilitación avulsion
• First Posted: July 19, 2018
• Last Update Posted: July 20, 2018
• Last Verified: July 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pelvic Floor Disorders; Obstetric Labor Complications; Disease; Pathologic Processes; Pregnancy Complications