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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Dietary Supplement: Dietary control
* Drug: Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Incidence of GDM<br>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. | Dietary Supplement: Dietary control<br> <br> Drug: Insulin<br>* If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized and insulin will be used. The kind of insulin used depends on the need of patients.<br>* Other names: Novolin 50R;|
| Other: Gestational outcomes<br>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. | Dietary Supplement: Dietary control<br> <br> Drug: Insulin<br>* If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized and insulin will be used. The kind of insulin used depends on the need of patients.<br>* Other names: Novolin 50R;|
| Other: Metabolic disorder<br>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. | Dietary Supplement: Dietary control<br> <br> Drug: Insulin<br>* If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized and insulin will be used. The kind of insulin used depends on the need of patients.<br>* Other names: Novolin 50R;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of GDM at the second gestational trimester | 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. | at the second gestational trimester(about 24-28 gestational weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational outcomes | The adverse gestational outcomes will be recorded. For example: GDM, preeclampsia,fetal growth restriction(FGR),and so on. | After delivery |