EUCTR2018-000003-16-GB进行中（未招募）1 期
Prevention of Gestational Diabetes in Obese Pregnant Women; a Proof of Principle Study Targeting Early Pregnancy Intervention to Women at Risk - UPBEAT-TIF
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Female, over 16 years
- •BMI =30kg/m2
- •High risk of GDM as identified by the risk assessment at screening
- •Singleton pregnancy
- •Gestation 21-14+6 weeks’ at the time of screening consent
- •Willing and able to give written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 75
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Women identified as being low risk of GDM
- •Pre-existing diabetes
- •HbA1c =6.5mmol/l at screening in early pregnancy
- •Hypertension requiring treatment pre-pregnancy/in pregnancy
- •Thyroid disease
- •Coeliac disease
- •Systemic Lupus Erythematosus
- •Antiphospholipid syndrome (APS)
- •Thalassaemia
- •Current psychosis
- •Taking metformin
- •Taking medications that affect insulin sensitivity
- •Past bariatric surgery
- •Sickle Cell
- •Multiple pregnancy
- •Insufficient understanding of the trial
- •Participation in another IMP trial at the time of screening consent
- •Contraindications to Metformin:
- •Hypersensitivity to metformin hydrochloride or to any of the excipients.
- •Diabetic ketoacidosis, diabetic pre-coma
- •Renal failure or renal dysfunction (creatinine clearance < 60 mL/min)
- •Acute conditions with the potential to alter renal function such as:
- •- dehydration
- •- severe infection
- •- intravascular administration of iodinated contrast agents
- •Acute or chronic disease which may cause tissue hypoxia such as:
- •- cardiac or respiratory failure
- •- recent myocardial infarction
- •Hepatic insufficiency, acute alcohol intoxication, alcoholism
- •Lactation
- •Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
- •Severe renal failure (GFR <30 mL/min)
研究者
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