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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Fecal Incontinence

Treatments: Procedure: vaginal delivery; Procedure: caesarean section

Study type: Interventional

Funder types: Other

Identifiers

NCT00632567

P060246

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 554 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• More than 18 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 stage 4
• Indication of a scheduled caesarean section not for proctologic reason
• Patient physically, mentally or legally incompetent to give informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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554 participants in 2 patient groups

1

Experimental group

Description:

caesarean section

Treatment:

Procedure: caesarean section

2

Active Comparator group

Description:

vaginal delivery

Treatment:

Procedure: vaginal delivery