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Prenatal Pelvic Floor Prevention (3PN)

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ClinicalTrials.gov Identifier: NCT00551551
Recruitment Status : Completed
First Posted : October 31, 2007
Last Update Posted : July 26, 2013
Sponsor:
Collaborators:
CIC-EC Réunion
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

Brief 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.


Condition or disease Intervention/treatment Phase
Urinary Incontinence Anal Incontinence Genital Prolapse Other: Pelvic floor muscle training with physiotherapist Other: Written information about kegel exercises Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Urinary Postpartum Handicap Prevention: Pelvic Floor Exercises vs Control. Multicentric Randomized Trial
Study Start Date : November 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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 Names:
  • pelvic floor exercises
  • Pelvic Floor Muscle Training
  • pelvic floor physiotherapy

Other: Written information about kegel exercises
Information about pelvic floor disorders prevention with personal pelvic floor exercises
Other Name: kegel exercises

Active Comparator: Control
Written instructions about personal (Kegel) pelvic floor exercises
Other: Written information about kegel exercises
Information about pelvic floor disorders prevention with personal pelvic floor exercises
Other Name: kegel exercises




Primary Outcome Measures :
  1. Urinary incontinence score assessed with ICIQ-SF questionnaire [ Time Frame: one year post partum ]

Secondary Outcome Measures :
  1. Urinary incontinence prevalence [ Time Frame: pregnancy end, 2 and 12 months post partum ]
  2. Other pelvic floor symptoms (anal incontinence, pain, sexual troubles) [ Time Frame: pregnancy end, 2 and 12 months post partum ]
  3. Genital prolapse assessed by POP-Q [ Time Frame: 2 months post-partum ]
  4. Pelvic floor strength [ Time Frame: 2 months post partum ]
  5. Quality of life (Euroquol 5D, Contilife) [ Time Frame: at delivery, 2 and 12 months post partum ]
  6. pad-test [ Time Frame: 2 months post partum ]
  7. need to medical care [ Time Frame: 12 months post partum ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551551


Locations
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France
CHR Réunion, CH Félix-Guyon
Saint-Denis, Réunion, France, 97405
CHU Antoine-Béclère
Clamart, France, 92141
CHU Clermont
Clermont-Ferrand, France, 63058
CHU Caremeau
Nimes, France, 30900
CH Poissy-Saint-Germain
Saint-Germain, France, 78105
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
CIC-EC Réunion
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Xavier FRITEL, MD, PhD CHR Réunion, CH Félix Guyon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT00551551     History of Changes
Other Study ID Numbers: 3PN
AFSSAPS-2007-A00641-52
First Posted: October 31, 2007    Key Record Dates
Last Update Posted: July 26, 2013
Last Verified: July 2013

Keywords provided by Centre Hospitalier Universitaire de la Réunion:
Pelvic floor
Kegel exercises
Quality of Life
Pelvic Pain

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Prolapse
Fecal Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases