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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The main objective of this study : Demonstrate that GBS (group B streptococci) "ST-17" colonize and persist to 60 days twice in the digestive tract of newborns that strains of GBS non-ST-17.
Secondary objectives:Determine:
Women tested positive for GBS during systematic vaginal screening at 35-37 weeks, will be proposed to participate to the study and will be included after reading the information letter and signature the consent form.
INCLUSION (D0 at time of delivery)
In the labor ward, two women's groups 1 and 2:
Group 1 = Women tested positive for GBS pre-selected and included in the protocol (see pre-inclusion) Group 2 = Women without antenatal vaginal screening and at risk of neonatal infection.
For both groups, at time of delivery:
At the beginning of the labour performed vaginal swabs (PV0):
For all women included (Group 1 and Group 2 women with a positive GBS vaginal sample) will be achieved in the delivery room:
For mothers, the collection of 3-5 ml of milk when breastfeeding.
Monitoring schedule:
Day 21 and day 60 post delivery:
the following samples for search of GBS for will be performed to gather the primary endpoint:
For the mother:
For the newborn:
Processing bacteriological samples:
All samples will be subjected to bacteriological analysis and DNA extraction for detection of GBS. GBS isolated will be identified and stored at - 80 ° C in a declared biological collection. DNA extracts will also stored at -20 ° C in a declared biological collection. All samples for microbiological analysis will be stored at - 80 ° C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Group B Streptococcus vaginal sample | Other | At time of delivery we will performed vaginal swabs in two groups: women tested positive for GBS at 35-37 weeks and women with risk of neonatal infection. For all women included will be achieved in the delivery room: a blood sample to the mother and a sampling of umbilical cord blood. Newborns will have a search for GBS (standard culture) in the stools and the pharynx. For mothers, the collection of milk when breastfeeding. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Samples | Other | At time of delivery we will performed vaginal swabs in two groups: women tested positive for GBS at 35-37 weeks and women with risk of neonatal infection. For both groups:
For all women included will be achieved in the delivery room:
Newborns of mothers included (group 1 and 2) will have a search for GBS (standard culture) in the stools and the pharynx prior to return home. For mothers, the collection of 3-5 ml of milk when breastfeeding. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of the hyper-virulent ST17 clone of Group B Strep | Detection of the hyper-virulent ST17 clone of Group B Strep (GBS) in the prevention of neonatal GBS meningitis. The main objective is to demonstrate that the hypervirulent ST17 GBS clone colonizing the mother and postpartum acquired colonizes and persists at 60 days post delivery in the gut of new born significantly more than non-ST17 GBS strains. | at 60 days post delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Digestive colonization | Digestive colonization of ST17 clone of Group B Strep in the newborns | at day 21 |
| Milk colonization | Colonization of milk by ST17 clone of Group B Strep |
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Inclusion Criteria:
Exclusion Criteria:
- Patient does not speak and does not understand French
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| Name | Affiliation | Role |
|---|---|---|
| Claire POYART, MD, PhD | Cochin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Mourier Hospital | Colombes | 92 700 | France | |||
| Cochin Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30946447 | Result | Tazi A, Plainvert C, Anselem O, Ballon M, Marcou V, Seco A, El Alaoui F, Joubrel C, El Helali N, Falloukh E, Frigo A, Raymond J, Trieu-Cuot P, Branger C, Le Monnier A, Azria E, Ancel PY, Jarreau PH, Mandelbrot L, Goffinet F, Poyart C. Risk Factors for Infant Colonization by Hypervirulent CC17 Group B Streptococcus: Toward the Understanding of Late-onset Disease. Clin Infect Dis. 2019 Oct 30;69(10):1740-1748. doi: 10.1093/cid/ciz033. | |
| 29082442 |
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| ID | Term |
|---|---|
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012494 | Sampling Studies |
| ID | Term |
|---|---|
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
| at day 21 and day 60 |
| Vaginal colonization | Vaginal colonization by ST17 clone of Group B Strep | at day 21 and day 60 |
| Late neonatal infections | Late neonatal infections will be observed between 3 weeks and 60 days | between 3 weeks and 60 days |
| Paris |
| 75014 |
| France |
| Result |
| Plainvert C, El Alaoui F, Tazi A, Joubrel C, Anselem O, Ballon M, Frigo A, Branger C, Mandelbrot L, Goffinet F, Poyart C. Intrapartum group B Streptococcus screening in the labor ward by Xpert(R) GBS real-time PCR. Eur J Clin Microbiol Infect Dis. 2018 Feb;37(2):265-270. doi: 10.1007/s10096-017-3125-2. Epub 2017 Oct 29. |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |