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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01320995
• Collaborator: (none)
• Enrollment: 111
• Locations: 2
• Arms: 2
• Duration (Months): 30
• Patients Per Site: 55.5
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Sep 1, 2011
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

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

Primary Outcome Measures

1. Presence/absence of anal incontinence [3 months]

   Anal incontinence is defined as a Wexner score > 4

Secondary Outcome Measures

1. Wexner anal incontinence score [3 months]

2. Visual Analog Scale for discomfort during perineal ultrasound [2 hours]

   Ranges from 0.0 to 10.0

3. Kappa coefficient for second reading of ultrasounds [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 [2 hours]

   Presence/absence of a sphincter tear immediately after delivery.

5. Patient requires anal sutures (yes/no) [2 hours]

   Patient requires anal sutures after delivery?

6. Presence/absence of suture infection [3 months]

   Has an infection ocurred between delivery and the follow up visit at 3 months post partum?

7. Questionnaire PFIQ [3 months]

8. Questionnaire PFDI [3 months]

9. Questionnaire SF36 [3 months]

10. Questionnaire Euroqol [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Nîmes	Nîmes Cedex 09	Gard	France	30029
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT01320995
• Other Study ID Numbers: AOI/2010/VL-02; 2011-A00050-41
• First Posted: Mar 23, 2011
• Last Update Posted: Mar 25, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Centre Hospitalier Universitaire de Nīmes: Second degree vaginal tear; Perineal ultrasound; Anal incontinence

Study Results

No Results Posted as of Mar 25, 2015