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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01320995
First received: March 22, 2011
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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
Parturition
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320995

Locations
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
Principal Investigator: Vincent Letouzey, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on July 20, 2014