Verifying Post-delivery Anal Sphincter Integrity Using Perineal Ultrasound: Impact on Immediate Care

Delivery, Obstetric Clinical Trial

— OASIS 2  

Official title:

Verifying Anal Sphincter Integrity in the Delivery Room Using a Specific Perineal Ultrasound: Impact on Immediate Care and Postpartum Anal Incontinence Rates in Mothers Undergoing Vaginal Birth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905644
• Other study ID #: AOI/2012/VL-01
• Secondary ID: 2013-A00773-42
• Status: Completed
• Phase: N/A
• First received: July 19, 2013
• Last updated: June 16, 2017
• Start date: March 7, 2014
• Est. completion date: April 15, 2017

Study information

• Verified date: June 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to compare post partum rates of anal sphincter rupture (that is to say the rate of sutures) diagnosed in women with ≥ 2nd degree vaginal tears between two groups: (1) women who are screened just after delivery by performing a perineal ultrasound versus a similar group of women who did not receive screening. This study was not designed to evaluate ultrasound as a diagnostic test but to compare the rate of perineal surgical procedures in each arm.

Description:

The secondary objectives of this study are:

A. Compare the anal incontinence score (measured by the Wexner score, qualitative and quantitative assessment) at 3 months between the two groups.

B. To assess the safety of perineal ultrasound in the group with "ultrasound" using a visual analog scale for discomfort

C. Assess the inter and intra operator consistency of perineal ultrasound snapshot readings

D. Evaluate and compare the rate of infectious complications of perineal sutures between the two groups at 3 months.

E. Evaluate and compare the quality of life (questionnaires PFIQ, PFDI, SF36, Euroqol) between the two groups at 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: April 15, 2017
• Est. primary completion date: November 24, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must have given 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

• Paturient, vaginal births only

• Presence of >= stage 2 perineal lesion

• Patient accepts a priori the performance of a perineal ultrasound

Exclusion Criteria:

• The patient is participating in another study (excepting BBBOX (2011-A00327-36), ElastoMAP (2013-A01148-37), ElastoDéclench, BAKRI, Papillo PMA, GrossPath, LXRs, DGPostPartum, "scalp lactates", and UpSideDown studies)

• The patient is in an exclusion period determined by a previous study

• 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

• Delivery by C-section

• Intact perineum after delivery (no indication for perineal surgery in light of absence of vaginal lesion)

• Emergency situation preventing time for perineal ultrasound

• History of anal incontinence before giving birth

• Allergy to ultrasound gel

Related Conditions & MeSH terms

• Delivery, Obstetric

Intervention

Procedure:
• Perineal ultrasound
Perineal ultrasound will be used after delivery to help detect anal sphincter ruptures.

Locations

Country	Name	City	State
France	CHU de Montpellier - Hôpital Arnaud de Villeneuve	Montpellier
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9
France	CHU de Poitiers	Poitiers Cedex

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 an anal sphincter rupture		Day 0
Secondary	Wexner score for anal incontinence		Day 0
Secondary	Wexner score for anal incontinence		3 months
Secondary	Tolerance of perineal ultrasound	Visual analog scale (0 to 10) used to evaluate discomfort.	Day 0
Secondary	Kappa coefficient for inter-operator ultrasound reading		Day 0
Secondary	Kappa coefficient for intra-operator ultrasound reading		Day 0
Secondary	Presence/absence of suture infection		3 months
Secondary	PFIQ questionnaire		Day 0
Secondary	PFIQ questionnaire		3 months
Secondary	PFDI questionnaire		Day 0
Secondary	PFDI questionnaire		3 months
Secondary	SF36 questionnaire		Day 0
Secondary	SF36 questionnaire		3 months
Secondary	Euroqol questionnaire		Day 0
Secondary	Euroqol questionnaire		3 months