ACTRN12620000359932尚未招募未知
Probiotics in the prevention of Gestational Diabetes Mellitus in women at increased risk: a prospective randomised controlled trial.
Dr Anushika Samarage0 个研究点目标入组 340 人开始时间: 2020年3月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 340
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 40 Years（—）
- 性别
- Female
入选标准
- •All pregnant women >10 weeks gestation, in a singleton pregnancy at increased risk of gestational diabetes as per the Australasian Diabetes in Pregnancy Society (ADIPS) criteria will be eligible for the study:
- •Previous GDM
- •Maternal age 18 years to 40 years
- •Family history of diabetes (1st degree relative with diabetes or a sister with GDM)
- •BMI over 35kg/m2
- •Previous macrosomia (baby birth weight over 4500g or over 90th centile)
- •Polycystic ovarian syndrome
排除标准
- •Not being able to read and understand English – unable to provide informed consent.
- •Age <18 years
- •Pregnancy >16 weeks gestation at recruitment
- •Known pre-existing diabetes, impaired fasting glucose or impaired glucose tolerance
- •GDM prior to recruitment as diagnosed by early pregnancy glucose testing – Early
- •pregnancy glucose testing routinely done for women at increased risk of GDM
- •Medications likely to influence glucose metabolism – metformin, glucocorticoids,
- •immunosuppressants
- •Medical conditions with altered glucose metabolism – Cushing/s syndrome, hepatic
- •Known major fetal anomaly on ultrasound
- •Known current ingestion of probiotics via capsules or sachets
- •Antibiotic use during the study period
研究者
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