ACTRN12615000239561招募中不适用
Randomized Double-blind Placebo-controlled Trial of Probiotics in Pregnancy and its effect on Group-B Streptococcal Colonization
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 460
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- Female
入选标准
- •1. Pregnant women between 23-28 weeks gestation.
- •2. 18-55 years of age
- •3. Singleton gestation
排除标准
- •1. Pre-existing morbidity:
- •*inflammatory bowel disease (Crohn's disease or ulcerative colitis);
- •*stomach or duodenal ulcer; bowel resection, gastric bypass, and chronic indwelling venous, bladder, or gastric catheter,
- •*Immunocompromised status (HIV +; malignancy; history of organ transplant; chronic steroid therapy; autoimmune disease requiring treatment during pregnancy, and other immunocompromised states);
- •*Type 1 diabetes and type 2 diabetes;
- •*congenital cardiac disease and cardiac valvular disease requiring antibiotic prophylaxis during procedure/labour; pulmonary disease (except mild asthma);
- •*renal disease;
- •*chronic hepatic disease (Hepatitis B, C);
- •2. Multi-foetal gestation.
- •3.Use of probiotics preparations in the 3 months prior to beginning of the study treatment or use of any additional probiotics preparations (other than study treatment) at any time during the study period (including over the counter food supplements such as Activia, other oral or vaginal probiotics products (BUT not including other common forms of yogurt).
- •4. Chronic (daily) use of broad spectrum antibiotics.
- •5. History of infant with GBS sepsis.
- •6. Foetal Anomalies-major diagnosed at time of second trimester anatomy ultrasound
- •7. Anticipated delivery <35 weeks for maternal/foetal indication
- •8. Placenta Previa or accreta (with anticipated delivery prior to 35 weeks)
- •9. Women with a cognitive impairment, an intellectual disability or a mental illness
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