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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01320995
Recruitment Status : Terminated
First Posted : March 23, 2011
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parturition Procedure: Perineal ultrasound Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Presence/absence of anal incontinence [ Time Frame: 3 months ]
    Anal incontinence is defined as a Wexner score > 4


Secondary Outcome Measures :
  1. Wexner anal incontinence score [ Time Frame: 3 months ]
  2. Visual Analog Scale for discomfort during perineal ultrasound [ Time Frame: 2 hours ]
    Ranges from 0.0 to 10.0

  3. 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.

  4. Presence/absence of a sphincter tear [ Time Frame: 2 hours ]
    Presence/absence of a sphincter tear immediately after delivery.

  5. Patient requires anal sutures (yes/no) [ Time Frame: 2 hours ]
    Patient requires anal sutures after delivery?

  6. 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?

  7. Questionnaire PFIQ [ Time Frame: 3 months ]
  8. Questionnaire PFDI [ Time Frame: 3 months ]
  9. Questionnaire SF36 [ Time Frame: 3 months ]
  10. Questionnaire Euroqol [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320995


Locations
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France
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
Investigators
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Principal Investigator: Vincent Letouzey, MD Centre Hospitalier Universitaire de Nîmes
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01320995    
Other Study ID Numbers: AOI/2010/VL-02
2011-A00050-41 ( Other Identifier: RCB number )
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Second degree vaginal tear
Perineal ultrasound
Anal incontinence