ParturitionOASIS 1NCT01320995
Perineal Echography in the Delivery Room for the Detection of Anal Lesions
A study testing Perineal ultrasound in people with Parturition, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
The main objective of this study is to compare the rate of anal incontinence (measured by the Wexner score, qualitative and quantitative (> 4)) at 3 months post partum among primiparas with vaginal tears ≥ 2nd degree who receive a sphincter injury screening at delivery by conducting a sphincter ultrasound in the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Parturition
- 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
- 111 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2011to Mar 2014
- 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 his/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
- The patient is delivering her first child; vaginal delivery
- The patient has a minimum stage 2 perineal lesion
- The patient accepts perineal echography
Who cannot join
- 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
- Cesarien section
- No perineal lesion (intact perineum)
- Emergency situation which hinders screening for anal lesions under good medical conditions
- Previous vaginal delivery
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Montpellier
Montpellier, 34295
Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, 30029
About this study
Official title: Perineal Echography in the Delivery Room for the Detection of Anal Lesions Among Primiparous Mothers: a Randomized Study
The main objective of this study is to compare the rate of anal incontinence (measured by the Wexner score, qualitative and quantitative (> 4)) at 3 months post partum among primiparas with vaginal tears ≥ 2nd degree who receive a sphincter injury screening at delivery by conducting a sphincter ultrasound in the delivery room versus a similar group of women who do not benefit from screening.
- Conditions
- Parturition
- Being tested
- Perineal ultrasound
- Keywords
- Second degree vaginal tear, Perineal ultrasound, Anal incontinence
- Medical subject headings
- Encopresis
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 is performed after delivery in order to better detect sphincter lesions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | In this arm, perineal ultrasound is used directly after delivery in order to hypothetically better detect anal lesions. Receives: Procedure: Perineal ultrasound |
| Standard arm | No intervention | No perineal ultrasound immediately after delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of anal incontinence
Anal incontinence is defined as a Wexner score > 4
Measured: 3 months
Secondary outcomes (10)
Wexner anal incontinence score
Measured: 3 months
Visual Analog Scale for discomfort during perineal ultrasound
Ranges from 0.0 to 10.0
Measured: 2 hours
Kappa coefficient for second reading of ultrasounds
A second reading of each ultrasound is obtained within 30 days. The Kappa coefficient of concordance will be calculated between the two readings.
Measured: 30 days
Presence/absence of a sphincter tear
Presence/absence of a sphincter tear immediately after delivery.
Measured: 2 hours
Patient requires anal sutures (yes/no)
Patient requires anal sutures after delivery?
Measured: 2 hours
Presence/absence of suture infection
Has an infection ocurred between delivery and the follow up visit at 3 months post partum?
Measured: 3 months
Questionnaire PFIQ
Measured: 3 months
Questionnaire PFDI
Measured: 3 months
Questionnaire SF36
Measured: 3 months
Questionnaire Euroqol
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParturitionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Letouzey, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320995
- Sponsor's protocol ID
- AOI/2010/VL-02
- Other IDs
- 2011-A00050-41
- Acronym
- OASIS 1
- Status last verified
- Mar 2015
- First submitted
- 22 Mar 2011
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Huberlant S, Mousty E, Bourgaux JF, Vincens C, Alonso S, de Tayrac R, Letouzey V, Lamouroux A. Feasibility of transperineal ultrasound in the delivery room for the management of obstetric anal sphincter injuries: a randomized controlled trial. J Gynecol Obstet Hum Reprod. 2026 Sep;55(7):103207. doi: 10.1016/j.jogoh.2026.103207. Epub 2026 May 9.
PubMed 42114594
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineal Echography in the Delivery Room for the Detection of Anal Lesions Among Primiparous Mothers: a Randomized Study
- ClinicalTrials.gov ID
- NCT01320995
- Acronym / sponsor ID
- OASIS 1 / AOI/2010/VL-02
- Conditions
- Parturition
- Keywords
- Second degree vaginal tear, Perineal ultrasound, Anal incontinence
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to compare the rate of anal incontinence (measured by the Wexner score, qualitative and quantitative (> 4)) at 3 months post partum among primiparas with vaginal tears ≥ 2nd degree who receive a sphincter injury screening at delivery by conducting a sphincter ultrasound in the delivery room versus a similar group of women who do not benefit from screening.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Procedure: Perineal ultrasoundIn this arm, perineal ultrasound is used directly after delivery in order to hypothetically better detect anal lesions. |
| Standard arm | No intervention | –No perineal ultrasound immediately after delivery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient must have given his/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
- The patient is delivering her first child; vaginal delivery
- The patient has a minimum stage 2 perineal lesion
Key exclusion criteria (7 listed)
- 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
- Cesarien section
- No perineal lesion (intact perineum)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal ultrasoundPerineal ultrasound is performed after delivery in order to better detect sphincter lesions. | Procedure or surgery | Experimental arm |
Primary outcome
Presence/absence of anal incontinence
Time frame: 3 months
Anal incontinence is defined as a Wexner score > 4
10 secondary outcomes
Wexner anal incontinence score
Time frame: 3 months
Visual Analog Scale for discomfort during perineal ultrasound
Time frame: 2 hours
Kappa coefficient for second reading of ultrasounds
Time frame: 30 days
Presence/absence of a sphincter tear
Time frame: 2 hours
Patient requires anal sutures (yes/no)
Time frame: 2 hours
Presence/absence of suture infection
Time frame: 3 months
Questionnaire PFIQ
Time frame: 3 months
Questionnaire PFDI
Time frame: 3 months
Questionnaire SF36
Time frame: 3 months
Questionnaire Euroqol
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Results publication: PubMed 42114594Huberlant S, Mousty E, Bourgaux JF, Vincens C, Alonso S, de Tayrac R, Letouzey V, Lamouroux A. Feasibility of transperineal ultrasound in the delivery room for the management of obstetric anal sphincter injuries: a randomized controlled trial. J Gynecol Obstet Hum Reprod. 2026 Sep;55(7):103207. doi: 10.1016/j.jogoh.2026.103207. Epub 2026 May 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Letouzey, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal ultrasound in people with Parturition, run by Centre Hospitalier Universitaire de Nīmes at 2 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 7 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: stopped early, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early. Results are not available in the source record.
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 anal incontinence (time frame: 3 months). 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 NCT01320995, which also lists 1 linked publication.
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 20 May 2026.