Prenatal Pelvic Floor Prevention (3PN)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-09-30

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.

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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.

Conditions

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Urinary Incontinence Anal Incontinence Genital Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Rééducation

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

Group Type EXPERIMENTAL

Pelvic floor muscle training with physiotherapist

Intervention Type OTHER

8 sessions of 20-30 minutes each between 24 and 36 weeks of gestation with a physiotherapist or midwife

Written information about kegel exercises

Intervention Type OTHER

Information about pelvic floor disorders prevention with personal pelvic floor exercises

Control

Written instructions about personal (Kegel) pelvic floor exercises

Group Type ACTIVE_COMPARATOR

Written information about kegel exercises

Intervention Type OTHER

Information about pelvic floor disorders prevention with personal pelvic floor exercises

Interventions

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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

Intervention Type OTHER

Written information about kegel exercises

Information about pelvic floor disorders prevention with personal pelvic floor exercises

Intervention Type OTHER

Other Intervention Names

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pelvic floor exercises Pelvic Floor Muscle Training pelvic floor physiotherapy kegel exercises

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No