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Delivery, ObstetricOASIS 2NCT01905644

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

A study testing Perineal ultrasound in people with Delivery, Obstetric, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Delivery, Obstetric
What is being tested?
Perineal ultrasound
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
3 sitesFrance
Study dates
7 Mar 2014to 15 Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • CHU de Montpellier - Hôpital Arnaud de Villeneuve

    Montpellier, 34295

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

  • CHU de Poitiers

    Poitiers, 86021

Other trials in France

About this study

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

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.

Read the detailed description

The secondary objectives of this study are:

  1. Compare the anal incontinence score (measured by the Wexner score, qualitative and quantitative assessment) at 3 months between the two groups.
  2. To assess the safety of perineal ultrasound in the group with "ultrasound" using a visual analog scale for discomfort
  3. Assess the inter and intra operator consistency of perineal ultrasound snapshot readings
  4. Evaluate and compare the rate of infectious complications of perineal sutures between the two groups at 3 months.
  5. Evaluate and compare the quality of life (questionnaires PFIQ, PFDI, SF36, Euroqol) between the two groups at 3 months.
Being tested
Perineal ultrasound
Keywords
Vaginal delivery, Perineal lesions, Anal sphincter rupture, Ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Perineal ultrasoundProcedure or surgery

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

Study groups in NCT01905644
Study groupRoleWhat they receive
With ultrasoundExperimentalPatients in this group will have perineal ultrasound for the detection of anal sphincter ruptures. Intervention: Perineal ultrasound
Receives: Procedure: Perineal ultrasound
Without ultrasoundNo interventionPatients in this group will not have perineal ultrasound for the detection of anal sphincter ruptures.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence/absence of an anal sphincter rupture

    Measured: Day 0

Secondary outcomes (14)

  1. Wexner score for anal incontinence

    Measured: Day 0

  2. Wexner score for anal incontinence

    Measured: 3 months

  3. Tolerance of perineal ultrasound

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

    Measured: Day 0

  4. Kappa coefficient for inter-operator ultrasound reading

    Measured: Day 0

  5. Kappa coefficient for intra-operator ultrasound reading

    Measured: Day 0

  6. Presence/absence of suture infection

    Measured: 3 months

  7. PFIQ questionnaire

    Measured: Day 0

  8. PFIQ questionnaire

    Measured: 3 months

  9. PFDI questionnaire

    Measured: Day 0

  10. PFDI questionnaire

    Measured: 3 months

  11. SF36 questionnaire

    Measured: Day 0

  12. SF36 questionnaire

    Measured: 3 months

  13. Euroqol questionnaire

    Measured: Day 0

  14. Euroqol questionnaire

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2013 (estimated)
  2. Study start7 Mar 2014
  3. Primary completion24 Nov 2016
  4. Study completion15 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01905644
Sponsor's protocol ID
AOI/2012/VL-01
Other IDs
2013-A00773-42
Acronym
OASIS 2
Status last verified
Jun 2017
First submitted
19 Jul 2013
Last updated
19 Jun 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Perineal ultrasound in people with Delivery, Obstetric, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence/absence of an anal sphincter rupture (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01905644.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2017.

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