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

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ClinicalTrials.gov Identifier: NCT01905644
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Delivery, Obstetric Procedure: Perineal ultrasound

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Actual Study Start Date : March 7, 2014
Primary Completion Date : November 24, 2016
Study Completion Date : April 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears Ultrasound
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905644


Locations
France
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
Investigators
Principal Investigator: Vincent Letouzey, MD Centre Hospitalier Universitaire de Nîmes
More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01905644     History of Changes
Other Study ID Numbers: AOI/2012/VL-01
2013-A00773-42 ( Other Identifier: RBC number )
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Vaginal delivery
Perineal lesions
Anal sphincter rupture
Ultrasound