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Extraction of whole blood from 10 to 15ml at 24 weeks before pregnancy test, with a view to early detection of GDM, provides evidence for early intervention to improve maternal pregnancy outcomes and metabolic abnormalities.
1. Pregnancy cohort management and follow-up
2. Collection Time and Content of Clinical Indicators
3. Collection time and content of laboratory indicators
4. GDM diagnostic criteria 75g OGTT method: OGTT fasting at least 8 hours before the test, continuous 3 days normal diet before the test, that is, eating carbohydrates not less than 150g per day, sit-in during the examination, smoking ban. At the time of examination, 5 min was taken orally with a liquid of 75g of glucose, and 1 and 2 hours of venous blood(calculated from the start of drinking glucose water) was extracted from the pregnant woman before and after taking sugar, and placed in a test tube containing sodium fluoride. Glucose oxidase method was used to determine blood sugar level.
The diagnostic criteria for 75g OGTT: 1, 2 H before and after taking sugar, 3 blood sugar values should be below 5.1, 10.0, 8.5 mmol/L(92, 180, 153 mg/dl), respectively. Any blood sugar value that reaches or exceeds the above criteria is diagnosed as GDM.
5. Measures to manage GDM Since there is currently no basis for the GDM management of pregnant women who meet the GDM diagnostic criteria 24 weeks ago, the OGTT anomaly is sufficient to diagnose the GDM for the standardized management of gestational diabetes. Refer specifically to the Guide for the Diagnosis and Treatment of Pregnancy with Diabetes(2014). Any test of abnormal glycolipids metabolism, or any other test to diagnose diabetes complicated pregnancy(this diagnosis is different from GDM, with an empty abdomen of 7.0 mmol/L or 2 H to 11.1 mmol/L), Both began management of diabetes during pregnancy(the group will withdraw from the study).
6. Monitoring and follow-up during childbirth. 6.1 Clinical data collection on pregnant women during childbirth Items to be collected during the birth of a pregnant woman: pregnancy, perinatal complications, mode of delivery, and the duration of the birth.
6.2 Laboratory data collection on pregnant women during childbirth Pregnant women during childbirth: peripheral blood sugar test(fasting and 2 hours after meal blood sugar), glycated hemoglobin.
6.3 Neonatal clinical and laboratory data collection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gestational Diabetes Mellitus | The diagnosis of GDM is based on a 75-g oral glucose tolerance test (OGTT) performed between 24 and 28 gestational weeks, according to the American diabetes association (ADA) criteria (fasting ≥ 5.1 mmol/L, 1 h ≥ 10.0 mmol/L, 2 h ≥ 8.5 mmol/L). Recruited patients were accepted the standard of treatment of GDM according to the American college of obstetricians and gynecologists (ACOG) practice bulletin on gestational diabetes mellitus. | ||
| Non-Gestational Diabetes Mellitus | normal group |
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| Measure | Description | Time Frame |
|---|---|---|
| New biomarkers levels in different pregnant weeks |
| the basic point (11-13+6 weeks), 18-20 weeks as the first changed point, 24-28 weeks as the second changed point,delivery weeks as the first outcome point, 6 months after delivery as the second outcome point |
| Evaluation of new biomarkers on the criteria | New biomarker tests show how consistent with GDM from The International Association of Diabetes and Pregnancy Study Groups criteria. We will do some new biomarker tests such as plasma mannose Levels, retinol-binding protein 4 and angiopoietin-like protein 4 and so on. There are 30-40 types' new biomarkers which is proved that it is relative with glycolipid metabolism on recent studies during 5 years. Evaluate the risk and the correlation between new biomarker and maternal and neonatal clinical outcomes. | the basic point (11-13+6 weeks), 18-20 weeks as the first changed point, 24-28 weeks as the second changed point,delivery weeks as the first outcome point, 6 months after delivery as the second outcome point |
| Evaluation of the postpartum recovery follow up GDM or non-GDM | World Health Organization Quality of Life Scale (WHOQOL 100) to evaluate subjects is only in 2 weeks for the labour.(All instructions and details are followed by the website:https://www.who.int/mental\_health/publications/whoqol/en/ , such as scale design and scores calculation). |
| Measure | Description | Time Frame |
|---|---|---|
| Expenditure on health products and drugs before diagnosed GDM | we collect the name, type and value of health product and drugs before before diagnosed GDM among our samples | before 13+6 weeks as the first time, before the diagnosis of GDM as the second time |
| Expenditure on GDM after the diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
pregnant women
4, after the birth to obtain placental tissue, umbilical cord endothelial tissue and umbilical cord blood.
5.Follow up study the prognosis of gestational diabetes.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Ye, graduate | Contact | 0756-2528188 | zdwygcp@126.com | |
| Yuhang Long, postgraduate | Contact | 13763379833 | longyh7@mail2.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhaojuan Su, postgraduate | Fifth Affiliated Hospital, Sun Yat-Sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Fifth Affiliated Hospital of Sun Yat-sen University of Gynaecology and Obstetrics | Recruiting | Zhuhai | Guangdong | 519000 | China |
This study is a prospective, single blind and observational clinical study. In order to evaluate the long-term effects of GDM on blood sugar, the early screening of GDM was studied through the changes in metabolic levels between different gestation ages.
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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whole blood and placenta, umbilical cord endothelial tissue and umbilical cord blood after the delivery
| 3 days after delivery by conduct of interviews; |
| Edinburgh postpartum depression scale (EPDS) follow up GDM or non-GDM | There are three models on postpartum depression:the mild postpartum depression is 10-12 scores;the moderate postpartum depression is 13-15 scores;the severe postpartum depression is over 16 scores. Meanwhile, the scale design and other instructions come from the article.(Cox, J., Holden, J., & Sagovsky, R. (1987). Detection of Postnatal Depression: Development of the 10-item Edinburgh Postnatal Depression Scale. British Journal of Psychiatry, 150(6), 782-786. doi:10.1192/bjp.150.6.782) | 3days after delivery by conduct of interviews; 6 months after delivery by wechat app |
we count number of hospitalization and collect fee of outpatient and hospitalization |
| after 24-28weeks as the first time, after 28 weeks until before the delivery hospitalization as the second time, the delivery hospitalization as the third time |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |