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

NCT00632567 | Completed

• 1 other identifier: P060246
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fecal Incontinence

Keywords

Anal incontinence; First delivery was traumatic; No anal incontinence

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is comparison of median incontinence score of VAIZEY in the two arms after 6 months.

  6 months

Secondary Outcomes (1)

• 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

  6 month and 12 month

Study Arms (2)

1

EXPERIMENTAL

caesarean section

Procedure: caesarean section

2

ACTIVE COMPARATOR

vaginal delivery

Procedure: vaginal delivery

Interventions

caesarean section PROCEDURE

caesarean section for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.

1

vaginal delivery PROCEDURE

vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• More than 18 years old
• Having health insurance
• Second pregnancy
• First delivery was traumatic
• No anal incontinence
• Accept to participate, sign the informed consent
• Prior medical examination

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital BICHAT

Paris, 75018, France

Location

MeSH Terms

Conditions

Fecal Incontinence; Encopresis

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Laurent ABRAMOWITZ, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 10, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

FR (1)