NCT01320995

Brief Summary

The main objective of this study is to compare the rate of anal incontinence (measured by the Wexner score, qualitative and quantitative (\> 4)) at 3 months post partum among primiparas with vaginal tears ≥ 2nd degree who receive a sphincter injury screening at delivery by conducting a sphincter ultrasound in the delivery room versus a similar group of women who do not benefit from screening.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

2.5 years

First QC Date

March 22, 2011

Last Update Submit

March 24, 2015

Conditions

Parturition

Keywords

Second degree vaginal tearPerineal ultrasoundAnal incontinence

Outcome Measures

Primary Outcomes (1)

  • Presence/absence of anal incontinence

    Anal incontinence is defined as a Wexner score \> 4

    3 months

Secondary Outcomes (10)

  • Wexner anal incontinence score

    3 months

  • Visual Analog Scale for discomfort during perineal ultrasound

    2 hours

  • Kappa coefficient for second reading of ultrasounds

    30 days

  • Presence/absence of a sphincter tear

    2 hours

  • Patient requires anal sutures (yes/no)

    2 hours

  • +5 more secondary outcomes

Study Arms (2)

Experimental arm

EXPERIMENTAL

In this arm, perineal ultrasound is used directly after delivery in order to hypothetically better detect anal lesions.

Procedure: Perineal ultrasound

Standard arm

NO INTERVENTION

No perineal ultrasound immediately after delivery.

Interventions

Perineal ultrasoundPROCEDURE

Perineal ultrasound is performed after delivery in order to better detect sphincter lesions.

Experimental arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 3 months of follow up
  • The patient is delivering her first child; vaginal delivery
  • The patient has a minimum stage 2 perineal lesion
  • The patient accepts perineal echography

You may not qualify if:

  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • Cesarien section
  • No perineal lesion (intact perineum)
  • Emergency situation which hinders screening for anal lesions under good medical conditions
  • Previous vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Study Officials

  • Vincent Letouzey, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 22, 2011

First Posted

March 23, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

FR(2)