Perineal Echography in the Delivery Room for the Detection of Anal Lesions (OASIS 1)

This study has been completed.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes Identifier:
First received: March 22, 2011
Last updated: March 17, 2014
Last verified: March 2014

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.

Condition Intervention
Procedure: Perineal ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Perineal Echography in the Delivery Room for the Detection of Anal Lesions Among Primiparous Mothers: a Randomized Study

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Presence/absence of anal incontinence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Anal incontinence is defined as a Wexner score > 4

Secondary Outcome Measures:
  • Wexner anal incontinence score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Visual Analog Scale for discomfort during perineal ultrasound [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Ranges from 0.0 to 10.0

  • Kappa coefficient for second reading of ultrasounds [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    A second reading of each ultrasound is obtained within 30 days. The Kappa coefficient of concordance will be calculated between the two readings.

  • Presence/absence of a sphincter tear [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Presence/absence of a sphincter tear immediately after delivery.

  • Patient requires anal sutures (yes/no) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Patient requires anal sutures after delivery?

  • Presence/absence of suture infection [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Has an infection ocurred between delivery and the follow up visit at 3 months post partum?

  • Questionnaire PFIQ [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Questionnaire PFDI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Questionnaire SF36 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Questionnaire Euroqol [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: September 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental arm
In this arm, perineal ultrasound is used directly after delivery in order to hypothetically better detect anal lesions.
Procedure: Perineal ultrasound
Perineal ultrasound is performed after delivery in order to better detect sphincter lesions.
No Intervention: Standard arm
No perineal ultrasound immediately after delivery.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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
  Contacts and Locations
Please refer to this study by its identifier: NCT01320995

Centre Hospitalier Universitaire de Nîmes
Nîmes Cedex 09, Gard, France, 30029
CHU de Montpellier
Montpellier cedex 5, France, 34295
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Principal Investigator: Vincent Letouzey, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes Identifier: NCT01320995     History of Changes
Other Study ID Numbers: AOI/2010/VL-02, 2011-A00050-41
Study First Received: March 22, 2011
Last Updated: March 17, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Second degree vaginal tear
Perineal ultrasound
Anal incontinence processed this record on April 17, 2014