Perineal Echography in the Delivery Room for the Detection of Anal Lesions

Parturition Clinical Trial

— OASIS 1  

Official title:

Perineal Echography in the Delivery Room for the Detection of Anal Lesions Among Primiparous Mothers: a Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01320995
• Other study ID #: AOI/2010/VL-02
• Secondary ID: 2011-A00050-41
• Status: Terminated
• Phase: N/A
• First received: March 22, 2011
• Last updated: March 24, 2015
• Start date: September 2011
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 111
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Parturition

Intervention

Procedure:
• Perineal ultrasound
Perineal ultrasound is performed after delivery in order to better detect sphincter lesions.

Locations

Country	Name	City	State
France	CHU de Montpellier	Montpellier cedex 5
France	Centre Hospitalier Universitaire de Nîmes	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence/absence of anal incontinence	Anal incontinence is defined as a Wexner score > 4	3 months	No
Secondary	Wexner anal incontinence score		3 months	No
Secondary	Visual Analog Scale for discomfort during perineal ultrasound	Ranges from 0.0 to 10.0	2 hours	No
Secondary	Kappa coefficient for second reading of ultrasounds	A second reading of each ultrasound is obtained within 30 days. The Kappa coefficient of concordance will be calculated between the two readings.	30 days	No
Secondary	Presence/absence of a sphincter tear	Presence/absence of a sphincter tear immediately after delivery.	2 hours	No
Secondary	Patient requires anal sutures (yes/no)	Patient requires anal sutures after delivery?	2 hours	No
Secondary	Presence/absence of suture infection	Has an infection ocurred between delivery and the follow up visit at 3 months post partum?	3 months	No
Secondary	Questionnaire PFIQ		3 months	No
Secondary	Questionnaire PFDI		3 months	No
Secondary	Questionnaire SF36		3 months	No
Secondary	Questionnaire Euroqol		3 months	No