NCT01905644

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

March 7, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2017

Completed
Last Updated

June 19, 2017

Status Verified

June 1, 2017

Enrollment Period

2.7 years

First QC Date

July 19, 2013

Last Update Submit

June 16, 2017

Conditions

Delivery, Obstetric

Keywords

Vaginal deliveryPerineal lesionsAnal sphincter ruptureUltrasound

Outcome Measures

Primary Outcomes (1)

  • Presence/absence of an anal sphincter rupture

    Day 0

Secondary Outcomes (14)

  • Wexner score for anal incontinence

    Day 0

  • Wexner score for anal incontinence

    3 months

  • Tolerance of perineal ultrasound

    Day 0

  • Kappa coefficient for inter-operator ultrasound reading

    Day 0

  • Kappa coefficient for intra-operator ultrasound reading

    Day 0

  • +9 more secondary outcomes

Study Arms (2)

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

Perineal ultrasoundPROCEDURE

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

With ultrasound

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

Study Officials

  • Vincent Letouzey, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2013

First Posted

July 23, 2013

Study Start

March 7, 2014

Primary Completion

November 24, 2016

Study Completion

April 15, 2017

Last Updated

June 19, 2017

Record last verified: 2017-06

Locations

FR(3)