EUCTR2019-002880-82-GB进行中（未招募）1 期
Randomised controlled trial of Gestational treatment with Ursodeoxycholic Acid compared to Metformin to Reduce effects of Diabetes mellitus - GUARD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 158
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
- 性别
- Female
入选标准
- •1. Women between 16 and 45 years of age with GDM diagnosed at 26+0 to 30+6 weeks’ gestation in accordance with the NICE guidelines (one or more glucose concentrations of =5.6 mmol/l fasting or =7.8 mmol/l 2 hours after a standard 75g OGTT, and requiring pharmacological treatment).
- •2. Overweight or obese (Booking BMI =25 kg/m2)
- •3. Planned antenatal, birth intrapartum and postpartum care at the participating centre (i.e. not planning to move before delivery).
- •Eligibility criteria for GUARD MEC is included in the protocol in section 19.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 158
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 158
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Unwilling/unable to give written informed consent and comply with the requirements of the study protocol
- •2.Multiple pregnancies (twins, triplets etc) in current pregnancy
- •3.Congenital anomaly on ultrasound requiring fetal medicine input
- •4.Previous diagnosis of diabetes outside pregnancy
- •5.HbA1c at booking of current pregnancy of >48 mmol/mol or =6.5% (if available)
- •6.Significant pre-pregnancy comorbidities that increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in-patient admission (within previous year) in the opinion of the responsible clinician or the CI.
- •7.Significant co-morbidity in the current pregnancy, nephropathy (estimated GFR <60ml/min), other physical or psychological conditions likely to interfere with the conduct of the study and/or interpretation of the trial results in the opinion of the responsible clinician or the CI.
- •8.Not fluent in English and absence of interpreter or translation services (ie telephone translation services)
- •9.Participating in another intervention study where the results could influence GDM-related endpoints, in the opinion of the responsible clinician or the CI, or participation in a CTIMP during current pregnancy.
- •10.Known allergy/hypersensitivity/intolerance to the active substance or excipients or patients taking any medications which are contraindicated as per IMP SmPC (as per Section 5.7 of the protocol).
- •Eligibility criteria for GUARD MEC is included in the protocol in section 19.
研究者
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