EPIC :Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.
NCT ID: NCT00632567
Last Updated: 2016-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
554 participants
INTERVENTIONAL
2008-03-31
2016-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
caesarean section
caesarean section
caesarean section for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.
2
vaginal delivery
vaginal delivery
vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.
Interventions
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caesarean section
caesarean section for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.
vaginal delivery
vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.
Eligibility Criteria
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Inclusion Criteria
* 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
* Woman who have an anal operation
* Caesarean section
* First delivery with anal break stage 4
* Indication of a scheduled caesarean section not for proctologic reason
* Patient physically, mentally or legally incompetent to give informed consent
18 Years
FEMALE
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Laurent ABRAMOWITZ, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hopital BICHAT
Paris, , France
Countries
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Other Identifiers
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P060246
Identifier Type: -
Identifier Source: org_study_id