Verifying Post-delivery Anal Sphincter Integrity Using Pe... | NCT01905644

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

NCT01905644

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Jun 19, 2017Actual

Enrollment

276Actual

Phase

Not Applicable

Conditions

Delivery, Obstetric

Interventions

Perineal ultrasound

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-A00773-42	Other Identifier	RBC number

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 7, 2014Actual

Primary Completion Date

Nov 24, 2016Actual

Completion Date

Apr 15, 2017Actual

First Submitted Date

Jul 19, 2013

First Submission Date that Met QC Criteria

Jul 19, 2013

First Posted Date

Jul 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2017

Last Update Posted Date

Jun 19, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

276Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With ultrasound	Experimental	Patients in this group will have perineal ultrasound for the detection of anal sphincter ruptures. Intervention: Perineal ultrasound	Procedure: Perineal ultrasound
Without ultrasound	No Intervention	Patients in this group will not have perineal ultrasound for the detection of anal sphincter ruptures.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Perineal ultrasound	Procedure	Perineal ultrasound will be used after delivery to help detect anal sphincter ruptures.	With ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence/absence of an anal sphincter rupture		Day 0

Secondary Outcomes

Measure	Description	Time Frame
Wexner score for anal incontinence		Day 0
Wexner score for anal incontinence		3 months
Tolerance of perineal ultrasound

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vincent Letouzey, MD	Centre Hospitalier Universitaire de Nīmes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Montpellier - Hôpital Arnaud de Villeneuve		Montpellier		34295	France
CHU de Nîmes - Hôpital Universitaire Carémeau