Trial record 2 of 12 for:    Open Studies | "Delivery, Obstetric"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01905644
First received: July 19, 2013
Last updated: May 9, 2014
Last verified: March 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wexner score for anal incontinence [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Wexner score for anal incontinence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Tolerance of perineal ultrasound [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Visual analog scale (0 to 10) used to evaluate discomfort.

  • Kappa coefficient for inter-operator ultrasound reading [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Kappa coefficient for intra-operator ultrasound reading [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Presence/absence of suture infection [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • PFIQ questionnaire [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • PFIQ questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • PFDI questionnaire [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • PFDI questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • SF36 questionnaire [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • SF36 questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Euroqol questionnaire [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Euroqol questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 276
Study Start Date: March 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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) and "scalp lactates" studies at the Nîmes University Hospital)
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01905644

Contacts
Contact: Vincent Letouzey, MD +33.(0)4.66.68.32.16 vincent.letouzey@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Montpellier - Hôpital Arnaud de Villeneuve Recruiting
Montpellier, France, 34295
Sub-Investigator: Anaig Flandrin, MD         
Sub-Investigator: Pierre Boulot, MD, PhD         
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 9, France, 30029
Principal Investigator: Vincent Letouzey, MD         
Sub-Investigator: Olivier Pouget, MD         
Sub-Investigator: Eve Mousty, MD         
Sub-Investigator: Renaud de Tayrac, MD, PhD         
Sub-Investigator: Pierre Marès, MD, PhD         
Sub-Investigator: Jean-François Bourgaux, MD         
CHU de Poitiers Recruiting
Poitiers Cedex, France, 86021
Sub-Investigator: Xavier Fritel, MD, PhD         
Sub-Investigator: Aurélie Brossard-Violeau, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Vincent Letouzey, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

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
Study First Received: July 19, 2013
Last Updated: May 9, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

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

ClinicalTrials.gov processed this record on October 23, 2014