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EPICc:Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.

This study is currenly Recruiting patients.
Sponsored by: Assistance Publique - Hôpitaux de Paris

Purpose
Anal incontinence is frequent and treatment is difficult. One of the most important reason is traumatic delivery. 10 % of women develop anal incontinence after first delivery. This incidence is higher after second vaginal delivery, particularly if the first delivery had break anal sphincter. One of the possibility to avoid anal incontinence is the caesarean section. So, do we have to recommend caesarean section for second delivery if the first was traumatic. But caesarean section had a morbidity. Actually, the choice between the delivery modalities is very subjective.
Study Type: Intervention
Condition Intervention Phase
Fecal Incontinence
Array: Array Array: Array N/A
Study Design:Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Official Title: Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.
Further Study Details:
Expected Total Enrollment:
Study Dates:March 2008 -
Anal incontinence is frequent and treatment is difficult. One of the most important reason is traumatic delivery. 10 % of women develop anal incontinence after first delivery. This incidence is higher after second vaginal delivery, particularly if the first delivery had break anal sphincter. One of the possibility to avoid anal incontinence is the caesarean section. So, do we have to recommend caesarean section for second delivery if the first was traumatic. But caesarean section had a morbidity. Actually, the choice between the delivery modalities is very subjective.It seems to be very useful to compare, in randomize control study, global morbidity of caesarean section and vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography. The primary endpoint is comparison of median incontinence score of VAISEY in the two arms after 6 months. The secondary endpoints are urinary incontinence, quality of life and global morbidity between the two arms after second delivery. We estimated, we need 129 women in each arm. Hospital investigators are : BICHAT Claude Bernard (Pr MADELENAT), Rothschild (Pr BENIFLA) and Jean VERDIER (Pr UZAN). Inclusion will be for 2 years and 3 months. Women will be included during the last trimester and evaluation will be perform on 8 weeks, 6 and 12 month after delivery.

Eligibility
Ages Eligible for Study- Min: 18 Years Max: N/A
Gender: Female
Criteria

Inclusion Criteria:

  • More than18 years old

  • having health insurance

  • Second pregnancy

  • Inclusion in the third trimester

  • First delivery was traumatic

  • No anal incontinence

  • accept to participate, sign the informed consent- prior medical examination

    Exclusion Criteria:

  • monitoring impossible

  • woman who have an anal operation

  • Caesarean section

  • First delivery with anal break stade 4.

  • Indication of a scheduled caesarean section not for proctologic reason

  • Patient physically, mentally or legally incompetent to give informed consent

  • Location and Contact Information
    Please refer to this study by ClinicalTrials.gov identifier: NCT00632567
    Hopital BICHAT - Paris, 75018
    Laurent ABRAMOWITZ, MD

    More Information
    Record Last Reviewed:February 2008
    Last Updated:March 26, 2008
    Record First Recieved:February 28, 2008
    ClinicalTrials.gov Identifier:NCT00632567
    Health Authority: United States Food and Drug Administration
    Information obtained from ClinicalTrials.gov on September 02, 2010

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