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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03592160
Other study ID # Rehabilitación avulsion
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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