Status:

UNKNOWN

Reproducibility of External Anal Sphincter Elastic Properties Assessment Using Elastography During Pregnancy

Lead Sponsor:

Poitiers University Hospital

Conditions:

Obstetric Anal Sphincter Injury

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

The risk prediction of obstetric anal sphincter injury couyl be optimized by considering pregnant women's anal sphincter intrinsic viscoelastic properties. Shear wave elastography is a new technology ...

Detailed Description

Investigations Assessment of the external anal sphincter viscoelastic properties using shear wave elastography technology using a transperineal approach in term pregnant women in two visits (the 1st o...

Eligibility Criteria

Inclusion

  • pregnant women aged of 18 years or more
  • 37 weeks or more of pregnancy
  • without any previous delivery (vaginal or cesarean delivery)
  • body mass index \< 35Kg.m-2
  • without history of Crohn's disease
  • without history of peri anal surgery
  • without any proctologic disease
  • without any muscular chronic disease
  • having a normal pregnancy
  • without any untreated psychiatric disorders
  • without any judicial protection
  • affiliated to a health insurance

Exclusion

  • pregnant women younger than 18 years old
  • obstetric term inferior than 37 weeks
  • history of vaginal and/or cesarean delivery
  • body mass index of 35Kg.m-2 or more
  • history of Crohn's disease
  • history of peri anal surgery
  • proctologic disease
  • muscular chronic disease
  • pathological pregnancy (intrauterine growth restriction, pre eclampsia etc..)
  • untreated psychiatric disorders
  • women under judicial protection
  • women without affiliated to a health insurance

Key Trial Info

Start Date :

July 7 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 14 2021

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT04350632

Start Date

July 7 2020

End Date

October 14 2021

Last Update

April 14 2021

Active Locations (1)

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1

CHU de Poitiers

Poitiers, France, 86000