Post Partum
Conditions
Brief summary
Objective: To compare the effectiveness of pelviperineal physiotherapy hypopressive exercise, and pelvic health education for the prevention and treatment of postpartum pelvic floor dysfunction in primiparous women after vaginal delivery.
Detailed description
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.
Interventions
OTHERPFM training
See information included in arm/group descriptions.
OTHERHE
See information included in arm/group descriptions.
BEHAVIORALEducational strategy
See information included in arm/group descriptions.
Sponsors
University of Alcala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
3 groups: 2 experimental groups and 1 control group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptoms and quality of life | 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention. | It will be assessed by PFDI-20 Spanish version that is both a symptom inventory and a measure of the degree of bother and distress caused by pelvic floor symptoms. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300 and the higher the score, the worse quality of life. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions collecting data about UI, POP and colorectal and anal symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in life impact of pelvic floor dysfunction | 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention. | It will be assessed by the PFIQ-7 Spanish version. The PFIQ-7 consists of 3 scales of 7 questions each taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The 3 scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300). |
| Pelvic floor muscle contraction and strenght | 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention. | Vaginal palpation will qualify PFM contraction and strength. using the Modified Oxford Score ranging from 0 to 5, according to the muscles contraction and strength. |
| Changes in sexual function | 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention. | It will be assessed using the Spanish version of the Female Sexual Function Index (FSFI). The FSFI consists of 19 items assessing six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain, with higher scores indicating better sexual function. |
| Change in pelvic floor muscle strength and tone | 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention. | It will be measured with dynamometry (gr) |
Countries
Spain
Outcome results
None listed