Clinical trial NCT03686956: Repair by Rehabilitation of Pelvic Floor Lesions After Vaginal Delivery Identified by Transperineal Ultrasound 3/4 D
Official title: Repair by Rehabilitation of Pelvic Floor Lesions After Vaginal Delivery Identified by Transperineal Ultrasound 3/4 D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Disorders
Obstetric Trauma
Physical Disorder
Physical Activity
Lead sponsor: Hospital Universitario de Valme
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To evaluate the changes in pressure in the contractility evaluated by manometry (mm Hg)
timeFrame: 6 months after randomisation
measure: Changes in muscle thickness (millimeters) of the levator ani muscle
timeFrame: 6 months after randomisation
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Nuestra Señora de Valme
Study officials:
affiliation: Hospital Universitario de Valme
name: José Antonio García Mejido
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sainz-Bueno JA, Bonomi MJ, Suarez-Serrano C, Medrano-Sanchez EM, Armijo A, Fernandez-Palacin A, Garcia-Mejido JA. Quantification of 3/4D ultrasound pelvic floor changes induced by postpartum muscle training in patients with levator ani muscle avulsion: a parallel randomized controlled trial. Quant Imaging Med Surg. 2022 Apr;12(4):2213-2223. doi: 10.21037/qims-21-877.