Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus and Improving Neonatal Outcome Regarding Birth Weight
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation
研究概览
简要总结
The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.
详细描述
The current study was conducted at Ain Shams university maternity hospital during the period between June 2016 to December 2016.
All patients were subjected to:
- History taking:
- General and Abdominal Examination:
With particular emphasis on :
- Body mass index
- Blood pressure.
- Fundal height .
- Estimated fetal weight .
- Insulin and metformin doses :
Insulin dose:
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
- Single (Participant)
盲法说明
Sixty-two opaque envelopes were numbered serially and in each envelope the corresponding letter which detect allocated group were put according to randomization then all envelops were closed and put in one box .When the first patient arrives , the first envelope were opened and the patient were allocated according to the letter inside .
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 20 - 35 years.
- •Gestational age: 20- 36 weeks gestation.
- •Singleton pregnancy.
- •Women with pregestational or gestational diabetes mellitus
排除标准
- •Pregnant women with secondary diabetes (e.g. those on chronic steroid therapy).
- •Hypertensive patients.
- •Women with impaired liver or renal function
- •Non-compliant patients.
研究组 & 干预措施
oral metformin and insulin
Intervention 'Insulin Mixtard' and Intervention 'metformin' had included
干预措施: Insulin Mixtard (Drug)
oral metformin and insulin
Intervention 'Insulin Mixtard' and Intervention 'metformin' had included
干预措施: Metformin (Drug)
insulin therapy only
Intervention 'Insulin Mixtard' had included
干预措施: Insulin Mixtard (Drug)
结局指标
主要结局
Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation
时间窗: from 20 weeks to 36 weeks gestation
Fasting and two-hours postprandial blood glucose every 48 hours, till reaching the target blood glucose concentrations: 60 - 95 mg/dl and \< 120 mg/dl (for fasting and two-hour postprandial status, respectively) If patient reached blood glucose concentrations, she considered as controlled Diabetes Mellitus If patient did not reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus
次要结局
- Number of Participants With a Macrosomic Baby(24 hours after delivery)
- Number of Participants With Neonates Who Were Hypoglycemic(24 hours after delivery)
研究者
Rehab Mohamed Abdelrahman
Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University
Ain Shams University