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

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ClinicalTrials.gov Identifier: NCT01320995
Recruitment Status : Terminated
First Posted : March 23, 2011
Last Update Posted : March 25, 2015
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

March 22, 2011
March 23, 2011
March 25, 2015
September 2011
March 2014   (Final data collection date for primary outcome measure)
Presence/absence of anal incontinence [ Time Frame: 3 months ]
Anal incontinence is defined as a Wexner score > 4
Same as current
Complete list of historical versions of study NCT01320995 on ClinicalTrials.gov Archive Site
  • Wexner anal incontinence score [ Time Frame: 3 months ]
  • Visual Analog Scale for discomfort during perineal ultrasound [ Time Frame: 2 hours ]
    Ranges from 0.0 to 10.0
  • Kappa coefficient for second reading of ultrasounds [ Time Frame: 30 days ]
    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 ]
    Presence/absence of a sphincter tear immediately after delivery.
  • Patient requires anal sutures (yes/no) [ Time Frame: 2 hours ]
    Patient requires anal sutures after delivery?
  • Presence/absence of suture infection [ Time Frame: 3 months ]
    Has an infection ocurred between delivery and the follow up visit at 3 months post partum?
  • Questionnaire PFIQ [ Time Frame: 3 months ]
  • Questionnaire PFDI [ Time Frame: 3 months ]
  • Questionnaire SF36 [ Time Frame: 3 months ]
  • Questionnaire Euroqol [ Time Frame: 3 months ]
Same as current
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Not Provided
Perineal Echography in the Delivery Room for the Detection of Anal Lesions
Perineal Echography in the Delivery Room for the Detection of Anal Lesions Among Primiparous Mothers: a Randomized Study
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.
Not Provided
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Procedure: Perineal ultrasound
Perineal ultrasound is performed after delivery in order to better detect sphincter lesions.
  • Experimental: Experimental arm
    In this arm, perineal ultrasound is used directly after delivery in order to hypothetically better detect anal lesions.
    Intervention: Procedure: Perineal ultrasound
  • No Intervention: Standard arm
    No perineal ultrasound immediately after delivery.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
2011-A00050-41 ( Other Identifier: RCB number )
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Vincent Letouzey, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP