Skip to content

Repair by Rehabilitation of Pelvic Floor Lesions After Vaginal Delivery Identified by Transperineal Ultrasound 3/4 D

Repair by Rehabilitation of Pelvic Floor Lesions After Vaginal Delivery Identified by Transperineal Ultrasound 3/4 D

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03686956
Enrollment
92
Registered
2018-09-27
Start date
2018-08-01
Completion date
2019-06-01
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Trauma, Pelvic Floor Disorders, Physical Activity, Physical Disorder

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.

Interventions

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.

Sponsors

Hospital Universitario de Valme
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the changes in pressure in the contractility evaluated by manometry (mm Hg)6 months after randomisationTo evaluate the changes in pressure in the contractility evaluated by manometry (mm Hg), of the medical floor produced by the treatment of postpartum physiotherapy of the pelvic floor
Changes in muscle thickness (millimeters) of the levator ani muscle6 months after randomisationChanges in muscle thickness (millimeters) of the levator ani muscle, measured with transperineal ultrasound 3-4D

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026