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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01320995
First received: March 22, 2011
Last updated: August 8, 2014
Last verified: August 2014

March 22, 2011
August 8, 2014
September 2011
March 2014   (final data collection date for primary outcome measure)
Presence/absence of anal incontinence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 ] [ 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 ]
Same as current
Not Provided
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Parturition
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.
 
Terminated
111
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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01320995
AOI/2010/VL-02, 2011-A00050-41
No
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
August 2014

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