Clinical Trials Logo

Clinical Trial Summary

Objective: To find out the effectiveness of pelvic-perineal physiotherapy in prevention and treatment of postpartum pelvic floor dysfunction caused by vaginal delivery.


Clinical Trial Description

Design: Randomized, controlled and single blinded clinical trial. Participants will be randomly assigned to one of these groups: Experimental group: pelvic-perineal physical therapy plus hypopressive exercises plus training in lifestyle advice; Experimental group II: hypopressive exercises plus training in lifestyle advice; Control group: just training in lifestyle advice. In the 3 groups several physical therapy assessments will be undertaken: 1st before intervention, 2nd immediately after completing intervention; 3th, 4th, 5th and 6th after 3, 6, 12 and 24 months. Study subjects: Postnatal women (6 and 8 weeks after vaginal delivery), primiparous, whose vaginal delivery has occurred in the "PrÍncipe de Asturias" Hospital, which have not been already treated for pelvic floor dysfunction, and after reading, understanding and freely signing an informed consent form. Sample size: 240 subjects will be included (80 subjects per group). Allowing for 15% of drop-outs and taking into account that 17% of women in the intervention group may develop pelvic floor dysfunction (urinary incontinence) versus 40% in the control group, with an alpha risk of 0.05, a beta risk of 0.1 in a bilateral contrast using the arcsine approximation. Data analysis: A descriptive analysis will be done of all variables. A confidence level of 95% (p <0,05) will be established for all the cases. Effectiveness will be evaluated by comparing between the two groups of the change in outcome variables between visits. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03247660
Study type Interventional
Source University of Alcala
Contact
Status Completed
Phase N/A
Start date October 2016
Completion date December 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05521646 - Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative N/A
Recruiting NCT04488276 - Effects of Second-hand Smoke on a Pregnant Woman
Not yet recruiting NCT04160273 - Evaluation of Postpartum Posttraumatic Stress Disorder at Angers University Hospital (ESPT-PP) N/A
Completed NCT00730704 - Acceptance of Human Papillomavirus Vaccination in Postpartum Women N/A
Completed NCT04550364 - MUMMIBODIES. Eating Disorders, Pregnancy and Post Partum Period.
Recruiting NCT05236023 - Family Centred Healthcare - Zero Separation and Couplet Care N/A
Completed NCT03353012 - Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant Phase 4
Active, not recruiting NCT04244279 - The Efficacy of Ergonomic Intervention in Preventing Musculoskeletal Disorders Among Women After Giving Birth N/A
Completed NCT00433004 - Advance Supply of Emergency Contraception Compared to Routine Postpartum Care in Teens Phase 4