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

Pelvic Floor Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592160
• Other study ID #: Rehabilitación avulsion
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: September 30, 2016

Study information

• Verified date: July 2018
• Source: Hospital Universitario de Valme
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 30, 2016
• Est. primary completion date: August 1, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Nuestra Señora de Valme	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario de Valme	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contractility	Assess the improvement in contractility / tone, evaluated by manometry, of the pelvic floor produced by the treatment of postpartum physiotherapy of the pelvic floor.	6 months after randomisation
Secondary	Changes in the levator ani muscle	To estimate the ultrasonographic changes in the levator ani muscle after rehabilitation, determining the maximum thicknesses and levator ani muscle area.	6 months after randomisation