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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacteriological analysis of vaginal sample | Biological | Bacteriological analysis of vaginal sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence/absence of a vaginal lesion due to delivery | 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. | Upon delivery (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Recorded qualitative and quantitative analysis of vaginal flora in patient's file | Upon delivery (Day 0) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Laurie Becerra, Sage Femme | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Jean-Philippe Lavigne, MD, PhD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26544959 | Result | 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. |
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