Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 1:40 PM
Study NCT ID:
NCT00551551
Status:
COMPLETED
Last Update Posted:
2013-07-26
First Post:
2007-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prenatal Pelvic Floor Prevention (3PN)
Sponsor:
Centre Hospitalier Universitaire de la Réunion
Organization:
Study Overview
Official Title:
Urinary Postpartum Handicap Prevention: Pelvic Floor Exercises vs Control. Multicentric Randomized Trial
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| AFSSAPS-2007-A00641-52 | None | None | View |