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Completed

NCT Number: NCT00551551

Prenatal Pelvic Floor Prevention (3PN)

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic floor muscle training with physiotherapist

Other

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

Written information about kegel exercises

Other

Information about pelvic floor disorders prevention with personal pelvic floor exercises

Other names: kegel exercises

Primary outcomes

  1. Urinary incontinence score assessed with ICIQ-SF questionnaire

    Time frame: one year post partum

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Collaborators

  • CIC-EC Réunion
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Oct 31, 2007
Registry last updated
Jul 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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