Insulin Versus Oral Hypoglycemic Agents in Gestational Diabetes Mellitus
Comparison of the Outcome of Insulin Versus Oral Hypoglycemic Agents in Gestational Diabetes Mellitus
研究概览
详细说明
A prevalent problem among pregnant women, gestational diabetes mellitus (GDM) typically manifests in the second and third trimesters. However, the reported frequency of GDM also varies globally due to variations in GDM diagnosis criteria. GDM raises the risk of harmful prenatal complications for both the mother and the fetus because of poorly managed blood glucose. Nonetheless, the application of more stringent criteria for the diagnosis of GDM (IADPSG criteria) is advised due to the recent advancements in our understanding of the condition, which will help with blood glucose control during pregnancy. Women are recommended to use diet and exercise to control their blood glucose levels after receiving a diagnosis of GDM. However, hypoglycemic medications like as insulin, metformin, glyburide, and in certain trials, acarbose, should be used for people who are unable to regulate their blood glucose.
When lifestyle changes are not successful, insulin has been the recommended treatment for GDM since it regulates blood glucose levels without passing through the placenta. The needs of each patient can be met by combining and matching formulations of short- and long-acting insulin. As treatments for GDM, oral hypoglycemic drugs such glyburide and metformin are becoming more and more well-liked. Metformin decreases the liver's production of glucose and increases insulin sensitivity, both of which result in lower blood glucose levels.6Gluburide encourages the pancreas to secrete more insulin. Despite being convenient and well-tolerated, there has been much debate and research over the safety and efficacy of oral administration during pregnancy.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Punjab Province
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Lodhran、Punjab Province、巴基斯坦
- Shahida Islam Teaching Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Every woman with a cephalic presentation of singleton pregnancy (as determined by ultrasonography) with gestational diabetes mellitus.
- A gestational age greater than 24 weeks (measured on LMP).
- Age range: 18-45.
- Parity 0-5
Exclusion Criteria:
- Expectant mothers who already have chronic diabetes mellitus.
- Women for whom oral hypoglycemics are contraindicated.
- Underlying conditions such severe chronic hypertension, thyroid illness, chronic renal insufficiency, and hepatic disease that are known to impact fetal growth or medication clearance.
- A history of insulin or metformin hypersensitivity
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:insulin
those in group B will get insulin (Humulin R) subcutaneously whose dose can be adjusted within 24 hours according to blood sugar levels, whereas those in group A will receive 500 mg tablets of metformin twice daily orally
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those in group B will get insulin (Humulin R) subcutaneously whose dose can be adjusted within 24 hours according to blood sugar levels, whereas those in group A will receive 500 mg tablets of metformin twice daily orally
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安慰剂比较:oral hypoglycemic group
For glycemic control and dosage modification, serum sugar levels will be checked on a regular basis.
Blood glucose levels will be monitored after a fast, one hour after eating, and two hours after eating.
Patients in which sugar cannot be controlled, then ward protocol can be followed for sugar control
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For glycemic control and dosage modification, serum sugar levels will be checked on a regular basis.
Blood glucose levels will be monitored after a fast, one hour after eating, and two hours after eating.
Patients in which sugar cannot be controlled, then ward protocol can be followed for sugar control
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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percentage of neonatal hypoglycemia
大体时间:24 hours
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neonatal glucose values <30 mg/dl on two consecutive occasions within 24 hour of birth as measured by glucometer
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24 hours
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合作者和调查者
调查人员
- 学习椅:mudassar pansota、Associate Professor of Urology, Shahida Islam Teaching Hospital, Lodhran, Pakistan
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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