Metformin in Mild Gestational Diabetes Mellitus : a double-blind placebo-controlled randomised trial

niversity Malaya Medical Centre0 个研究点目标入组 106 人开始时间: 2017年11月7日最近更新: 2022年11月7日

适应症

试验速览

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/33890319/ (added 27/10/2022)

•Current inclusion criteria as of 11/12/2017:
•1. Aged 18 to 45 years
•2. Singleton pregnancy
•3. Gestational age at recruitment 16-30 weeks
•4. Confirmed GDM: Fasting plasma glucose = 5.1 mmol/L and/or the 2-hour = 7.8 mmol/L by 75g OGTT
•5. Normal 4-point blood sugar profile (BSP) in the preceding 2 weeks: fasting/pre-prandial = 5.3, post prandial 1 hour of = 7.8 or post prandial 2 hours of = 6.7 mmol/L
•6. Not on any hypoglycaemic drug treatment
•Previous inclusion criteria:
•1. Aged 18 to 45 years
•2. Singleton pregnancy
•3. Gestational age at recruitment 16-30 weeks
•4. Confirmed GDM: Fasting plasma glucose = 5.1 mmol/L and/or the 2-hour = 7.8 mmol/L by 75g OGTT = 16 weeks of pregnancy
•5. Normal 4-point blood sugar profile (BSP) in the preceding 2 weeks: fasting/pre-prandial = 5.3, post prandial 1 hour of = 7.8 or post prandial 2 hours of = 6.7 mmol/L
•6. Not on any hypoglycaemic drug treatment

•1. Any contraindication to metformin
•2. History of prepregnant hyperglycaemia
•2.1. Type 2 diabetes,
•2.2. Impaired glucose tolerance
•2.3. Fasting glycaemia
•3. Diagnostic 75g OGTT: fasting plasma glucose = 7 or 2-hour glucose = 11.1 mmol/L

发起方

niversity Malaya Medical Centre