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Verifying Post-delivery Anal Sphincter Integrity Using Perineal Ultrasound: Impact on Immediate Care (OASIS 2)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes Identifier:
First received: July 19, 2013
Last updated: January 30, 2017
Last verified: January 2017
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.

Condition Intervention
Delivery, Obstetric
Procedure: Perineal ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Presence/absence of an anal sphincter rupture [ Time Frame: Day 0 ]

Secondary Outcome Measures:
  • Wexner score for anal incontinence [ Time Frame: Day 0 ]
  • Wexner score for anal incontinence [ Time Frame: 3 months ]
  • Tolerance of perineal ultrasound [ Time Frame: Day 0 ]
    Visual analog scale (0 to 10) used to evaluate discomfort.

  • Kappa coefficient for inter-operator ultrasound reading [ Time Frame: Day 0 ]
  • Kappa coefficient for intra-operator ultrasound reading [ Time Frame: Day 0 ]
  • Presence/absence of suture infection [ Time Frame: 3 months ]
  • PFIQ questionnaire [ Time Frame: Day 0 ]
  • PFIQ questionnaire [ Time Frame: 3 months ]
  • PFDI questionnaire [ Time Frame: Day 0 ]
  • PFDI questionnaire [ Time Frame: 3 months ]
  • SF36 questionnaire [ Time Frame: Day 0 ]
  • SF36 questionnaire [ Time Frame: 3 months ]
  • Euroqol questionnaire [ Time Frame: Day 0 ]
  • Euroqol questionnaire [ Time Frame: 3 months ]

Estimated Enrollment: 276
Study Start Date: March 2014
Estimated Study Completion Date: March 2017
Primary Completion Date: November 24, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: With ultrasound

Patients in this group will have perineal ultrasound for the detection of anal sphincter ruptures.

Intervention: Perineal ultrasound

Procedure: Perineal ultrasound
Perineal ultrasound will be used after delivery to help detect anal sphincter ruptures.
No Intervention: Without ultrasound
Patients in this group will not have perineal ultrasound for the detection of anal sphincter ruptures.

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01905644

CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 9, France, 30029
CHU de Poitiers
Poitiers Cedex, France, 86021
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Principal Investigator: Vincent Letouzey, MD Centre Hospitalier Universitaire de Nîmes
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes Identifier: NCT01905644     History of Changes
Other Study ID Numbers: AOI/2012/VL-01
2013-A00773-42 ( Other Identifier: RBC number )
Study First Received: July 19, 2013
Last Updated: January 30, 2017

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Vaginal delivery
Perineal lesions
Anal sphincter rupture
Ultrasound processed this record on April 28, 2017