Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Rate of maternal weight gain per week
研究概览
简要总结
Insulin has many disadvantages for mothers with GDM including the need to give injections, frequent daily testing for monitoring, and risks of hypoglycemia, increase in appetite, weight gain and high cost. Metformin, an oral biguanide, may be a more logical alternative to insulin for women with GDM who are unable to cope with the increasing insulin resistance of pregnancy.
This study aim to compare maternal weight gain during pregnancy in women with gestational diabetes, treated by insulin versus metformin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged (19-35) years
- •BMI 18-30 kg/m2
- •Gestational age >24 weeks
- •Singleton pregnancy
- •Gestational diabetes mellitus with failure to achieve adequate glucose control on diet therapy alone (FBG > 105) OR patients with gestational diabetes who are controlled with either metformin alone or insulin alone.
排除标准
- •Pregnant women with preexisting diabetes mellitus
- •Women who have contraindication to take metformin e.g.: impaired renal function, hepatic cirrhosis, hepatitis).
- •Patients with other medical disorders that could affect perinatal outcome (e.g., hypertension, SLE etc).
- •Fetal anomalies identified on ultrasound prior to initiation of therapy.
- •Patients who refused to participate
研究组 & 干预措施
Insulin Group
This includes women with GDM allocated to receive insulin treatment. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin.
干预措施: Insulin (Drug)
Insulin Group
This includes women with GDM allocated to receive insulin treatment. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin.
干预措施: Assessment of weight gain (Other)
Metformin Group
This includes women with GDM allocated to receive metformin treatment. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal.
干预措施: Metformin (Drug)
Metformin Group
This includes women with GDM allocated to receive metformin treatment. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal.
干预措施: Assessment of weight gain (Other)
结局指标
主要结局
Rate of maternal weight gain per week
时间窗: 4 months
Maternal weight (in grams) will be measured monthly. Difference in measured weight between starting treatment and delivery will be divided by the number of weeks.
次要结局
- Incidence of neonatal respiratory distress(1 day)
- 5-min APGAR score(5 minutes)
- Incidence of neonatal hypoglycemia(1 day)
- 1-min APGAR score(1 minute)
- Incidence of macrosomia(1 hour)
研究者
Sinaa Hamdy Abo ElWafa
Resident of O&G
Ain Shams University