Pelviperineal Physiotherapy in Postpartum

Design: Randomized, controlled and single blinded clinical trial. Participants will be randomly assigned to one of these groups: Experimental group: pelviperineal physical therapy plus pelvic health education and training in the Knack manoeuvre; Experimental group II: hypopressive exercises plus pelvic health education and training in the Knack manoeuvre; Control group: pelvic health education, training in the Knack manoeuvre, and general recommendations for pelvic floor muscle exercises at home. 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 and12 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: The sample size was calculated a priori using the PFDI-20 as the primary outcome. Based on a clinically meaningful between-group difference of 20 points and an SD of change of 31.2 points, 55 participants per group were required. A total of 165 participants were randomized (55 per group). Data analysis: A descriptive analysis will be performed for all variables. Intervention effects will be assessed using linear mixed-effects models for change from baseline, including group, time, and group-by-time interaction as fixed effects, with adjustment for the centered baseline value of the outcome and a participant-specific random intercept. A two-sided significance level of 0.05 will be used.

Inclusion criteria

• Postnatal women (6 and 8 weeks after vaginal delivery)
• Primiparous
• Whose vaginal delivery has occurred in the "Príncipe de Asturias" Hospital
• Women have not been already treated for pelvic floor dysfunction
• Women reading, understanding and freely signing an informed consent form

Exclusion criteria

• Postnatal women with medical diagnosis of pelvic floor dysfunction (PFD) prior to pregnancy and delivery
• Women with a history of conservative treatment or PFD surgery
• Women with concomitant or systemic disease that may affect the treatment (neurological, gynecological, urological or connective tissue), or with active or recurrent urinary infection without treatment at the time of the intervention proposed in this study, or hematuria.
• Women with perineal pain preventing vaginal dynamometry.
• Postnatal women with cognitive impairment or insufficient Spanish-language proficiency preventing adequate understanding of study procedures.
• Women with severe maternal complications or serious neonatal conditions.