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.
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
Please refer to this study by ClinicalTrials.gov identifier: NCT00632567
Hopital BICHAT - Paris, 75018
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