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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
280
8 sessions of 20-30 minutes each between 24 and 36 weeks of gestation with a physiotherapist or midwife
Information about pelvic floor disorders prevention with personal pelvic floor exercises
CHR Réunion, CH Félix-Guyon
Saint-Denis, Réunion, France
CHU Antoine-Béclère
Clamart, France
CHU Clermont
Clermont-Ferrand, France
CHU Caremeau
Nîmes, France
CH Poissy-Saint-Germain
Urinary incontinence score assessed with ICIQ-SF questionnaire
Time frame: one year post partum
Urinary incontinence prevalence
Time frame: pregnancy end, 2 and 12 months post partum
Other pelvic floor symptoms (anal incontinence, pain, sexual troubles)
Time frame: pregnancy end, 2 and 12 months post partum
Genital prolapse assessed by POP-Q
Time frame: 2 months post-partum
Pelvic floor strength
Time frame: 2 months post partum
Quality of life (Euroquol 5D, Contilife)
Time frame: at delivery, 2 and 12 months post partum
pad-test
Time frame: 2 months post partum
need to medical care
Time frame: 12 months post partum
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Saint-Germain, France