Insulin Analogue Versus Conventional Premixed Insulin in the Treatment of Diabetes Mellitus With Pregnancy: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 主要终点
- the percentage of maternal glycosylated Hemoglobin
研究概览
简要总结
The prevalence of diabetes melilites is rapidly increasing over years and consequently during pregnancy. In 2017, there were 21.3 million pregnant women who experienced hyperglycemia, of which 86.4% of them were diagnosed with gestational diabetes melilites.
Pregnancy in women with diabetes is associated with an intensification in adverse maternal, fetal and perinatal outcomes including spontaneous abortions, congenital malformations, preterm labor, and macrosomia. Several studies have confirmed that poor glycemic control in women with either gestational, type 1 or type 2 diabetes during pregnancy is associated with poor pregnancy outcomes. In the same line, proper glycemic control before, early, and through all pregnancy markedly improves both maternal and fetal outcomes.
Insulin therapy is the standard treatment of diabetes melilites with the pregnancy if dietary control and exercise fail. However, insulin therapy has its difficulties like approaches to mimicking postprandial insulin release, providing adequate background insulin, balancing insulin dosage, food, activity, hypoglycemic episodes, overall glycemia. This is always a struggle for doctors and patients and much affecting their lifestyle
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 否
入选标准
- •Age of 18 - 45 years old,
- •Women with pre-gestational diabetes.
- •Those who were under premixed insulin therapy prior to pregnancy.
- •women pregnant between 14 weeks up to 28 weeks of gestation
排除标准
- •History of recurrent miscarriage
- •multiple pregnancies
- •chronic hypertension
- •severe heart, liver, and kidney disease.
- •women how got pregnant after assisted reproduction
- •those with advanced retinopathy, hypersensitivity to insulin.
- •Women who developed bleeding in early pregnancy and those diagnosed to have any major anomaly during the first-trimester scan.
研究组 & 干预措施
Basal insulin analogue and premeal rapid acting insulin
干预措施: Basal insulin analogue (Drug)
Basal insulin analogue and premeal rapid acting insulin
干预措施: rapid acting insulin (Drug)
Neutral Protamine Hagedorn with regular insulin
干预措施: Neutral Protamine Hagedorn (Drug)
Neutral Protamine Hagedorn with regular insulin
干预措施: regular insulin (Drug)
结局指标
主要结局
the percentage of maternal glycosylated Hemoglobin
时间窗: 6 months
次要结局
未报告次要终点
研究者
Mohammed Khairy Ali
Assistant professor
Assiut University
