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| ID | Type | Description | Link |
|---|---|---|---|
| GDMTEST-5010-01 | Registry Identifier | Gynecology and obstetrics department of the 1st affiliated hospital of Sun Yat-sen University | |
| GDMTEST-5010-02 | Registry Identifier | Gynecology and obstetrics department of the 3rd affiliated hospital of Sun Yat-sen University | |
| GDMTEST-5010-03 | Registry Identifier | Guangdong women and children hospital | |
| GDMTEST-5010-04 | Registry Identifier | Guangzhou women and children hospital |
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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incidence of GDM | Other | 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. |
|
| Gestational outcomes | Other | 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. |
|
| Metabolic disorder | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary control | Dietary Supplement |
| ||
| Insulin |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of temporal and distant metabolic disorder of mother | After about 2 months after delivery when mother comes back for postpartum follow-up, some tests will be done, such as regular blood test,blood glucose(fasting and 2 hours after meal), urine regular test and so on. | 2 months to 1 year after delivery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zilian Wang, Doctor | Contact | 13602885248 | +86 | zilianwang@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecology and obstetrics department of the 1st affiliated hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| Drug |
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. |
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| Child growth measures |
Children's body weight and height will be firstly recorded when their mothers come back for postpartum follow-ups at about 2 months after delivery by asking them or measure their children on the spot if they take their children with them. And the growth measures of children will be recorded for the second time by asking them via telephone at about 1 year after delivery. |
| 2 months to 1 year after delivery |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D000068880 | Isophane Insulin, Human |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007336 | Insulin, Isophane |
| D049528 | Insulin, Long-Acting |
| D061386 | Insulin, Regular, Human |
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