EPIC :Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section. (EPIC)
|Study Design:||Allocation: Randomized
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.|
- The primary endpoint is comparison of median incontinence score of VAIZEY in the two arms after 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Incontinence scores in the two arms after 6/8 weeks and 6 month, transitional anal incontinence after delivery urinary incontinence 6 and 12 month after the delivery, sexual score(IFSI)global morbidity between the two arms after anal endoscopy [ Time Frame: 6 month and 12 month ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Procedure: caesarean section
caesarean section for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.
Active Comparator: 2
Procedure: vaginal delivery
vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.
Anal incontinence is frequent and treatment is difficult. One of the most important reasons 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 caused break in the anal sphincter. One possibility to avoid anal incontinence is the caesarean section.
So, do the investigators 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 randomized controlled 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. In start of study, all women were included, for randomisation ("section cesarean prophylactic" versus "vaginal delivery") if an anal sphincter rupture is diagnosed with anal endosonography before second delivery. . Currently, in case of refusal randomisation, women are proposed to participate to the ancillary study (cohort study).
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. The investigators estimated, needing 123 women in each arm.
Hospital investigators are: BICHAT Claude Bernard (Pr LUTON), Armand Trousseau (Pr BENIFLA), Jean VERDIER (Pr CARBILLON), BEAUJON (Pr LUTON), Louis MOURIER (Pr MANDELBROT), Versailles (Dr PANEL). Inclusion will be for 6 years and 9 months. Women will be included during the last trimester and evaluation will be perform on 8 weeks, 6 and 12 month after delivery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632567
|Contact: Laurent ABRAMOWITZ, MD||+33(0)1 40 25 80 80 ext bip email@example.com|
|Paris, France, 75018|
|Contact: Laurent ABRAMOWITZ, MD +33(0)1 40 25 80 80 firstname.lastname@example.org|
|Paris, France, 75018|
|Contact: Laurent ABRAMOWITZ, MD|
|Principal Investigator:||Laurent ABRAMOWITZ, MD||Assistance Publique - Hôpitaux de Paris|