Skip to main content
OpenTrials
Completed

NCT Number: NCT01905644

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Montpellier - Hôpital Arnaud de Villeneuve, Montpellier, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perineal ultrasound

Procedure

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

Primary outcomes

  1. Presence/absence of an anal sphincter rupture

    Time frame: Day 0

Secondary outcomes

  1. Wexner score for anal incontinence

    Time frame: Day 0

  2. Wexner score for anal incontinence

    Time frame: 3 months

  3. Tolerance of perineal ultrasound

    Time frame: Day 0

    Visual analog scale (0 to 10) used to evaluate discomfort.

  4. Kappa coefficient for inter-operator ultrasound reading

    Time frame: Day 0

  5. Kappa coefficient for intra-operator ultrasound reading

    Time frame: Day 0

  6. Presence/absence of suture infection

    Time frame: 3 months

  7. PFIQ questionnaire

    Time frame: Day 0

  8. PFIQ questionnaire

    Time frame: 3 months

  9. PFDI questionnaire

    Time frame: Day 0

  10. PFDI questionnaire

    Time frame: 3 months

  11. SF36 questionnaire

    Time frame: Day 0

  12. SF36 questionnaire

    Time frame: 3 months

  13. Euroqol questionnaire

    Time frame: Day 0

  14. Euroqol questionnaire

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: OASIS 2

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 23, 2013
Registry last updated
Jun 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.