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Clinical Trials/NCT01320995
NCT01320995
Terminated
Not Applicable

Perineal Echography in the Delivery Room for the Detection of Anal Lesions Among Primiparous Mothers: a Randomized Study

Centre Hospitalier Universitaire de Nīmes2 sites in 1 country111 target enrollmentStarted: September 2011Last updated:
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ConditionsParturition

Overview

Phase
Not Applicable
Status
Terminated
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
111
Locations
2
Primary Endpoint
Presence/absence of anal incontinence
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Presence/absence of anal incontinence

Time Frame: 3 months

Anal incontinence is defined as a Wexner score \> 4

Secondary Outcomes

  • 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)
  • Presence/absence of suture infection(3 months)
  • Questionnaire PFIQ(3 months)
  • Questionnaire PFDI(3 months)
  • Questionnaire SF36(3 months)
  • Questionnaire Euroqol(3 months)

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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