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临床试验/NCT04726631
NCT04726631已完成不适用

Insulin Analogue Versus Conventional Premixed Insulin in the Treatment of Diabetes Mellitus With Pregnancy: A Prospective Cohort Study

Assiut University0 个研究点目标入组 110 人开始时间: 2015年1月1日最近更新:
适应症
干预措施
相关药物

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

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

Other

干预措施: Basal insulin analogue (Drug)

Basal insulin analogue and premeal rapid acting insulin

Other

干预措施: rapid acting insulin (Drug)

Neutral Protamine Hagedorn with regular insulin

Other

干预措施: Neutral Protamine Hagedorn (Drug)

Neutral Protamine Hagedorn with regular insulin

Other

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Khairy Ali

Assistant professor

Assiut University

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