Vaginal LesionNCT01822782
Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?
An observational study of Vaginal Lesion, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to assess whether the presence of abnormal vaginal flora (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of delivery. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Vaginal Lesion
- What is being tested?
- Bacteriological analysis of vaginal sample
- How many people
- 1,100 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to 6 Dec 2013
- Phase
- Observational
- 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 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The study population consists of all consecutive women meeting inclusion/exclusion criteria and delivering at the Nîmes University Hospital, France during an inclusion period of 6 months.
Who may be able to join
- Pregnant women with a gestational age > 34 weeks delivering at the Nîmes University Hospital
Who cannot join
- Patient under judicial protection
- Adult patient under any kind of guardianship
- Patient refuses participation
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to assess whether the presence of abnormal vaginal flora (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of delivery. For this, the primary endpoint will be the proportion of vaginal lesions according to the presence or absence of abnormal vaginal flora.
A more precise qualitative and quantitative study of vaginal flora isolated from pregnant women and its association with vaginal lesions will also be conducted.
- Conditions
- Vaginal Lesion
- Being tested
- Bacteriological analysis of vaginal sample
- Keywords
- Perineal tear, Perineal lesion, Vaginal flora, Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacteriological analysis of vaginal sampleBiological
Bacteriological analysis of vaginal sample
| Study group | Role | What they receive |
|---|---|---|
| Cases | The study population consists of all consecutive women meeting inclusion/exclusion criteria and delivering at the Nîmes University Hospital, France during an inclusion period of 6 months. "Cases" are classified as those with a vaginal lesion due to delivery. Receives: Biological: Bacteriological analysis of vaginal sample | |
| Controls | The study population consists of all consecutive women meeting inclusion/exclusion criteria and delivering at the Nîmes University Hospital, France during an inclusion period of 6 months. "Controls" are classified as those without a vaginal lesion due to delivery. Receives: Biological: Bacteriological analysis of vaginal sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of a vaginal lesion due to delivery
Measured: Upon delivery (Day 0)
Record of abnormal vaginal flora (presence/absence of Nugent's score > 3) in patient's medical file
Record of routine analysis of vaginal samples during pregnancy will be used.
Measured: Upon delivery (Day 0)
Secondary outcomes (1)
Recorded qualitative and quantitative analysis of vaginal flora in patient's file
Measured: Upon delivery (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startJun 2013
- Primary completion6 Dec 2013
- Study completion6 Dec 2013
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 Vaginal LesionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie Becerra, Sage Femme, Principal investigator, Centre Hospitalier Universitaire de NīmesJean-Philippe Lavigne, MD, PhD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822782
- Sponsor's protocol ID
- LOCAL/2013/LB-01
- Status last verified
- Mar 2015
- First submitted
- 28 Mar 2013
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Letouzey V, Bastide S, Ulrich D, Beccera L, Lomma M, de Tayrac R, Lavigne JP. Impact of Bacterial Vaginosis on Perineal Tears during Delivery: A Prospective Cohort Study. PLoS One. 2015 Nov 6;10(11):e0139334. doi: 10.1371/journal.pone.0139334. eCollection 2015.
PubMed 26544959
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?
- ClinicalTrials.gov ID
- NCT01822782
- Acronym / sponsor ID
- LOCAL/2013/LB-01
- Conditions
- Vaginal Lesion
- Keywords
- Perineal tear, Perineal lesion, Vaginal flora, Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 6 Dec 2013 (actual)
- Study completion
- 6 Dec 2013 (actual)
- First posted
- 2 Apr 2013 (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 assess whether the presence of abnormal vaginal flora (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of delivery. For this, the primary endpoint will be the proportion of vaginal lesions according to the presence or absence of abnormal vaginal flora.
A more precise qualitative and quantitative study of vaginal flora isolated from pregnant women and its association with vaginal lesions will also be conducted.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Biological: Bacteriological analysis of vaginal sampleThe study population consists of all consecutive women meeting inclusion/exclusion criteria and delivering at the Nîmes University Hospital, France during an inclusion period of 6 months. "Cases" are classified as those with a vaginal lesion due to delivery. |
| Controls | – | Biological: Bacteriological analysis of vaginal sampleThe study population consists of all consecutive women meeting inclusion/exclusion criteria and delivering at the Nîmes University Hospital, France during an inclusion period of 6 months. "Controls" are classified as those without a vaginal lesion due to delivery. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of all consecutive women meeting inclusion/exclusion criteria and delivering at the Nîmes University Hospital, France during an inclusion period of 6 months.
Key inclusion criteria (1 listed)
- Pregnant women with a gestational age > 34 weeks delivering at the Nîmes University Hospital
Key exclusion criteria (3 listed)
- Patient under judicial protection
- Adult patient under any kind of guardianship
- Patient refuses participation
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 |
|---|---|---|
| Bacteriological analysis of vaginal sampleBacteriological analysis of vaginal sample | Biological | Cases, Controls |
Primary outcome
Presence/absence of a vaginal lesion due to delivery
Time frame: Upon delivery (Day 0)
Record of abnormal vaginal flora (presence/absence of Nugent's score > 3) in patient's medical file
Time frame: Upon delivery (Day 0)
Record of routine analysis of vaginal samples during pregnancy will be used.
1 secondary outcome
Recorded qualitative and quantitative analysis of vaginal flora in patient's file
Time frame: Upon delivery (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 26544959Letouzey V, Bastide S, Ulrich D, Beccera L, Lomma M, de Tayrac R, Lavigne JP. Impact of Bacterial Vaginosis on Perineal Tears during Delivery: A Prospective Cohort Study. PLoS One. 2015 Nov 6;10(11):e0139334. doi: 10.1371/journal.pone.0139334. eCollection 2015.
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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.
Laurie Becerra, Sage Femme principal investigator
Centre Hospitalier Universitaire de Nīmes
Jean-Philippe Lavigne, MD, PhD study director
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Lesion, run by Centre Hospitalier Universitaire de Nīmes at 1 site 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 1 inclusion and 3 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 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 a vaginal lesion due to delivery (time frame: Upon delivery (Day 0)). The study lists 2 primary outcomes in all. 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 NCT01822782, 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 19 Nov 2025.