Physiological Effects of Gestational Diabetes on the Placenta and Neonatal Outcome; Role of Antioxidant Administration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- neonatal outcome assessed by neonatal ICU admission
研究概览
简要总结
Fasting and two hours postprandial blood sugar were done to all cases between 28 and 32 weeks and high blood sugar levels were found so Cases were controlled by both diet and insulin.
The 200 pregnant women with Gestational diabetes mellitus were randomized using automated web based randomization system into 2 groups, Group1 received 1 gram L-ascorbic acid (vitamin C )per day from the time of diagnosis until the time of delivery in addition to routine treatment of diabetes (diet & insulin). Group2 received only the treatment of diabetes
详细描述
The 200 pregnant women with Gestational diabetes mellitus were randomized using automated web based randomization system into 2 groups, Group1 received 1 gram L-ascorbic acid oral once daily (vitamin C )per day from the time of diagnosis until the time of delivery in addition to routine treatment of diabetes (diet & insulin). Group2 received only the treatment of diabetes (diet and insulin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with the diagnosis of GDM
排除标准
- •Women with multiple pregnancies
- •Chronic medical disorders e.g. anemia
- •Hypertension
- •Liver disease or renal disease
- •Those with obstetric problems other than GDM (e.g. pre-eclampsia & antepartum hemorrhage) or smokers and women with preexisting type I or II diabetes mellitus were excluded from our study
研究组 & 干预措施
antioxidant
1 gram L-ascorbic acid (vitamin C capsule) orally once per day from the time of diagnosis until the time of delivery in addition to treatment for gestational diabetes mellitus in the form of diet and insulin
干预措施: L-ascorbic acid (Drug)
结局指标
主要结局
neonatal outcome assessed by neonatal ICU admission
时间窗: 1 week after delivery
次要结局
- oxidative stress parameters: non enzymatic and enzymatic oxidative stress parameters in maternal blood plasma/lysate in women with GDM named glutathione,superoxide dismutase ,catalase and glutathione peroxidase(9 months of pregnancy)
- oxidative stress parameters: non enzymatic and enzymatic oxidative stress parameters in neonatal blood in women with GDM named malondialdahyde and superoxide dismutase(9 months of pregnancy)
- oxidative stress parameters: non enzymatic and enzymatic oxidative stress parameters in placental tissue homogenates in women with GDM named glutathione ,malondialdahyde,superoxide dismutase ,catalase and glutathione peroxidase(9 months of pregnancy)
研究者
Ahmed Maged
Assistant professor
Cairo University