Study of the Digestive Colonization of the Newborn Children by the Streptococcus of the Group B
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 949
- 试验地点
- 4
- 主要终点
- Detection of the hyper-virulent ST17 clone of Group B Strep
研究概览
简要总结
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:
- The frequency of colonization with GBS ST-17 and GBS non-ST-17 of at risk pregnant women.
- The frequency of colonization of neonates by GBS ST-17 at birth.
- The preferential site of colonization in the mother (rectum, vagina, breast milk).
- The kinetics of colonization after birth in the newborn.
- The sensitivity and specificity of different GBS detection methods (conventional phenotypic versus molecular) in the different types of samples from the mother and the newborn.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient having a positive vaginal swab for GBS at the end of pregnancy (PCR +).
- •Patient aged over 18 years
- •Patient who received information and agreeing to sign informed consent
- •Patient affiliated or beneficiary of an insurance
排除标准
- •- Patient does not speak and does not understand French
研究组 & 干预措施
Positive Group B Streptococcus vaginal sample
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.
干预措施: Samples (Other)
结局指标
主要结局
Detection of the hyper-virulent ST17 clone of Group B Strep
时间窗: at 60 days post delivery
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.
次要结局
- Digestive colonization(at day 21)
- Milk colonization(at day 21 and day 60)
- Vaginal colonization(at day 21 and day 60)
- Late neonatal infections(between 3 weeks and 60 days)