Prenatal Pelvic Floor Prevention (3PN)

Study Overview
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Brief Summary
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Objective: Compare pelvic floor disorders (urinary incontinence, anal incontinence, genital prolapse, perineal pain, sexual troubles) 12 month after a first delivery between a group of women with prenatal pelvic floor exercises and a control group. Hypothesis: Prenatal pelvic floor exercises reduce postpartum urinary incontinence.

Detailed Description
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Justification: Pelvic floor disorders lead to handicap and medical care consumption. Pregnancy and delivery are the main etiologies. Pelvic floor exercises are proposed for prevention and may reduce immediate postpartum incontinence but we do not know if this preventive effect persists at 1 year. Principal criteria: Urinary incontinence score at 12 months post-partum (ICIQ-SF) Secondary criteria: Urinary incontinence prevalence at pregnancy end, 2 and 12 months post-partum Other pelvic floor disorders at pregnancy end, 2 and 12 months post-partum: symptoms questionnaires, QOL questionnaire, Pad-test, POP-Q. Mode of delivery, length of active second phase, perineal tears, Apgar score. Number of postpartum pelvic floor session, number of medical consultations, Kegel exercises. Progress: Inclusion between 20 and 28 weeks, initial assessment, randomization. 8 sessions of pelvic floor exercises with a physiotherapist between 24 and 36 weeks versus written information only. Assessment at pregnancy end, 2 and 12 (+/-1) month post-partum Study length: For each women 18 months. For each center 30 months. Number of subjects: To show a 1 point difference on ICIQ-SF score, we need 182 subjects (sd=2,4, a=0,05, β=0,20 bilateral test). Taking in account lost of follow-up (estimated 1/3) we are going to include 280 women.

Official Title
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Urinary Postpartum Handicap Prevention: Pelvic Floor Exercises vs Control. Multicentric Randomized Trial

Conditions
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Urinary Incontinence, Anal Incontinence, Genital Prolapse

Intervention / Treatment
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* Other: Pelvic floor muscle training with physiotherapist
* Other: Written information about kegel exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: nulliparous aged 18 years or more pregnant between 20 and 28 weeks French language reader Exclusion Criteria: No medical insurance multiple or pathologic pregnancy Previous pelvic floor exercises with a physiotherapist less than 6 months before pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rééducation<br>Standardized pelvic floor muscle training program with a physiotherapist in 8 sessions (20-30 minutes each) between 24 and 36 weeks of gestation AND Written instructions about personal (Kegel) pelvic floor exercises | Other: Pelvic floor muscle training with physiotherapist<br>* 8 sessions of 20-30 minutes each between 24 and 36 weeks of gestation with a physiotherapist or midwife<br>* Other names: pelvic floor physiotherapy;Other: Written information about kegel exercises<br>* Information about pelvic floor disorders prevention with personal pelvic floor exercises<br>* Other names: kegel exercises;|
| Active Comparator: Control<br>Written instructions about personal (Kegel) pelvic floor exercises | Other: Written information about kegel exercises<br>* Information about pelvic floor disorders prevention with personal pelvic floor exercises<br>* Other names: kegel exercises;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary incontinence score assessed with ICIQ-SF questionnaire |  | one year post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary incontinence prevalence |  | pregnancy end, 2 and 12 months post partum | 
| Other pelvic floor symptoms (anal incontinence, pain, sexual troubles) |  | pregnancy end, 2 and 12 months post partum | 
| Genital prolapse assessed by POP-Q |  | 2 months post-partum | 
| Pelvic floor strength |  | 2 months post partum | 
| Quality of life (Euroquol 5D, Contilife) |  | at delivery, 2 and 12 months post partum | 
| pad-test |  | 2 months post partum | 
| need to medical care |  | 12 months post partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic floor, Kegel exercises, Quality of Life, Pelvic Pain