Probiotics in Pregnancy and Rectovaginal Group B Streptococcus (GBS) Colonization
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 402
- 试验地点
- 6
- 主要终点
- GBS Rectovaginal colonization
研究概览
简要总结
Multicentric, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of GBS in women at low obstetric risk.
详细描述
Multicenter, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of GBS in women at low obstetric risk.
The study includes low obstetric risk pregnant women within the 33rd week of gestation, with vaginal delivery expected. It excludes women who during pregnancy had a positive urine culture for GBS, women with a previous newborn suffering from early sepsis, use of antibiotics in the month prior to enrollment, women unable to understand the study and sign informed consent.
Intervention Daily oral administration of two capsules of the Giellepi Spa class IIa medical device "Respecta" or placebo, to be taken with a glass of water preferably between meals, starting from the 30th week of pregnancy until the 37th week after having vagino-rectal swab screening performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The randomization (1: 1) will take place in each center, using the same allocation sequence, in blocks of 4, with the indication of the treatment code inserted in a white, closed envelope. The code will correspond to the number written on the packages to be administered and the list of codes containing the definition of the treatments, will be kept in a sealed envelope, by a collaborator of the PI (Head Nurse), and opened upon completion of the study or at the time of need, in case maternal-fetal or neonatal serious adverse event.
No member of the research team knows which treatment the patients receive because both the active and the placebo are packaged identically and are contained in identical white boxes. Only the randomization numbers distinguish them.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •low obstetric risk pregnant women by the 33rd week of gestation,
- •vaginal delivery expected.
排除标准
- •positive urine culture for GBS,
- •previous newborn suffering from early sepsis,
- •use of antibiotics in the month prior to enrollment,
- •women unable to understand the study and sign informed consent.
结局指标
主要结局
GBS Rectovaginal colonization
时间窗: at 35-37 weeks
Rate of colonized GBS pregnant (carriers) at the time of antepartum screening (35-37 \^ week).
次要结局
- Intrapartum antibiotics profilaxisi(during labor)
研究者
Prof. Fabio Facchinetti
Director of the Obstetrics and Gynecolocy department
University of Modena and Reggio Emilia