Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- maternal glycemic control
研究概览
简要总结
Gestational diabetic mellitus (GDM) patients randomised to metformin or insulin group.Aim was to achieve blood sugar levels of Blood sugar fasting (BSF) <5.3 mmol/l and 1 hour post meal<7.8mmol/l. Both groups were followed till delivery and outcome studied.
详细描述
75 gm Oral Glucose Tolerance Test (OGTT) was done in pregnant patients. Blood sugar fasting(BSF) > 5.5 mmol/l & 2 hours postprandial >7.8 mmol/l was labelled as GDM. They were randomised to metformin or insulin group. Those assigned to metformin group were started metformin 500mg twice daily & increased until 2500mg depending on the blood sugar levels. Aim was to achieve blood sugar levels of BSF <5.3 mmol/l and 1 hour post meal<7.8mmol/l. If blood sugar levels were not controlled, insulin was added. The insulin group was given 3 injections of regular insulin & one intermediate acting insulin injection at night subcutaneously. Both groups were followed till delivery and outcome studied
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All pregnant Diagnosed GDM in pregnancy by OGTT from 22 week to 34 week with singleton pregnancy
排除标准
- •Patients with Known diabetes mellitus
- •Patients with multiple pregnancy
- •With essential hypertension or pre eclampsia
- •Patients having fetal malformation incompatible with life
- •Patients with intrauterine death of fetus
研究组 & 干预措施
metformin
Metformin will be given until 2500mg in divided doses till normoglycemia is achieved and will be continued till delivery
干预措施: Metformin (Drug)
Insulin
Insulin will be give as 3 regular injection and one intermediate acting injection at bedtime till normoglycemia is achieved and will be continued till delivery
干预措施: Insulin (Drug)
结局指标
主要结局
maternal glycemic control
时间窗: From time of randomisation till 40 weeks
Maternal glycemic control was measured by blood sugar levels
次要结局
- Perinatal death(7 days of delivery)
- Neonatal hypoglycemia(at birth)
- mode of delivery(at delivery)
- Neonatal intensive care unit (NICU) stay(>24 hours after birth)
- Fetal macrosomia(at birth)
- Apgar score(at birth)
研究者
Tayyiba Wasim
Professor Obs Gynae
Services Institute of Medical Sciences, Pakistan