NCT00551551

Prenatal Pelvic Floor Prevention (3PN)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Centre Hospitalier Universitaire de la Réunion · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Urinary Incontinence
• Anal Incontinence
• Genital Prolapse

Interventions

Type	Name	Description
OTHER	Pelvic floor muscle training with physiotherapist	8 sessions of 20-30 minutes each between 24 and 36 weeks of gestation with a physiotherapist or midwife
OTHER	Written information about kegel exercises	Information about pelvic floor disorders prevention with personal pelvic floor exercises

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2007-10-31
• Last updated: 2013-07-26

Locations

5 sites across 1 country: France