Impact of Blood Glucose at the First Trimester of Pregnant Women With Gestational Diabetes on Maternal and Fetal Outcomes and Metabolic Disorders: a Multi-central Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- The incidence of GDM at the second gestational trimester
研究概览
简要总结
The study is to investigate the impact of blood glucose management at the first trimester of pregnant women with gestational diabetes on the maternal and fetal outcomes and metabolic disorder.
详细描述
Gestational diabetes(GDM) is the glucose metabolic disorder that first diagnosed during pregnancy. With the development of social economy and the improvement of life, the incidence of GDM increases to a level of 18-20% year by year. High blood glucose has a strong relationship with many adverse maternal and fetal outcomes, but also influences their metabolism including the increase of susceptibility of maternal type 2 diabetes and risk of fetal type 2 diabetes, obesity, coronary heart disease, etc. And therefore, it is significant to screening and managing maternal blood glucose to prevent maternal and fetal adverse outcomes and metabolic disorder.
This multi-central prospective cohort study is supposed to study the pregnant women whose fasting blood glucose is slightly increased (between 5.1 mmol/L and 7.0 mmol/L) at the first gestational trimester. The aim of this study is to answer the scientific questions bellow: whether interventions to whom the blood glucose is slightly increased can
- decrease the incidence of GDM at the second gestational trimester;
- improve gestational outcomes;
- decrease the incidence of temporal and distant metabolic disorder of mother and her child.
The result will provide scientific evidence for improving the gestational outcomes of GDM women and preventing metabolic disorder of their child during adolescence and adult period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •regular antenatal examination from the first trimester;
- •accurate left mentoposterior(LMP) verified by ultrasonography(USG);
- •fasting blood glucose level between 5.1 mmol/L and 7.0 mmol/L.
排除标准
- •younger than 18 years old;
- •do not give birth in the research centers above;
- •LMP is undefined and lack of USG during 6-14 gestational weeks;
- •multiple pregnancy;
- •non-natural pregnancy(including intrauterine insemination(IUI), in-vitro fertilization and embryo transfer(IVF-ET), etc);
- •diagnosed DM before pregnancy;
- •with hepatitis B virus, hepatitis C virus, HIV infection;
- •taking drugs including glucocorticoid, diuretic, angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker(ACEI/ARB), etc.
- •complicated with diseases that affect glucose metabolism such as hyperthyroidism and so on.
研究组 & 干预措施
Incidence of GDM
Dietary control will be suggested to patients if their fasting blood glucose is between 5.1 mmol/L and 7.0 mmol/L. If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized.
干预措施: Dietary control (Dietary Supplement)
Incidence of GDM
Dietary control will be suggested to patients if their fasting blood glucose is between 5.1 mmol/L and 7.0 mmol/L. If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized.
干预措施: Insulin (Drug)
Gestational outcomes
Dietary control will be suggested to patients if their fasting blood glucose is between 5.1 mmol/L and 7.0 mmol/L. If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized.
干预措施: Dietary control (Dietary Supplement)
Gestational outcomes
Dietary control will be suggested to patients if their fasting blood glucose is between 5.1 mmol/L and 7.0 mmol/L. If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized.
干预措施: Insulin (Drug)
Metabolic disorder
Dietary control will be suggested to patients if their fasting blood glucose is between 5.1 mmol/L and 7.0 mmol/L. If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized.
干预措施: Dietary control (Dietary Supplement)
Metabolic disorder
Dietary control will be suggested to patients if their fasting blood glucose is between 5.1 mmol/L and 7.0 mmol/L. If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized.
干预措施: Insulin (Drug)
结局指标
主要结局
The incidence of GDM at the second gestational trimester
时间窗: at the second gestational trimester(about 24-28 gestational weeks)
The results of oral glucose tolerance test(OGTT) at the second gestational trimester(about 24-28 gestational weeks) which is used to diagnose GDM will be recorded to analysis the incidence of GDM at the second gestational trimester.
次要结局
- Gestational outcomes(After delivery)
研究者
Zilian Wang
Doctor
First Affiliated Hospital, Sun Yat-Sen University