Early Screening of Gestational Diabetes Mellitus and Prospective Cohort Study of Postpartum Follow-up

Gestational Diabetes Mellitus Clinical Trial

Official title: Early Screening of Gestational Diabetes Mellitus and Prospective Cohort Study of Postpartum Follow-up

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

1. Pregnancy cohort management and follow-up

1. All pregnant women in the group are included in the study queue and have a uniform number, which is followed up until the birth.

2. Detailed case reporting forms have been developed to record the data.

3. We have set up a relatively complete electronic database of obstetrics, which will include modules related to this study, which will be available for this project management data.

4. This project has a full-time research assistant as a high-grade nurse. He is responsible for the maternity examination and follow-up of pregnant women in the group and ensures the norms of the maternity inspection process so as to reduce the heterogeneity caused by inconsistent labor inspection times. All birth tests are conducted in accordance with the Guidelines for Pre-conception and Pregnancy Care.

5. Pregnant women diagnosed as GDM will be managed in accordance with the Guide for the Diagnosis and Treatment of Pregnancy Combined with Diabetes(2014).

6. In addition to conducting five blood samples and tissue collection, we have followed the existing clinical principles and guidelines in handling and intervening in pregnancy and childbirth-related issues.

2. Collection Time and Content of Clinical Indicators

1. Data collection time nodes: pregnancy 11-13 + 6 weeks, pregnancy 18-20 weeks, pregnancy 24-28 weeks, hospitalization during childbirth, six months after delivery.

2. When entering the group: age, pre-pregnancy weight, height, pregnancy, birth; Ask for history, history of marriage and family history in detail.

3. items to be collected for each birth test: weight, blood pressure, palace height, abdominal circumference; Assess complications during pregnancy.

4. Pregnancy B Super monitoring: At least 11-13 weeks of early pregnancy B super, 18-24 weeks of three-dimensional color super, 32 weeks and 37 weeks of color Super.

3. Collection time and content of laboratory indicators

1. Data collection time nodes: pregnancy 11-13 + 6 weeks, pregnancy 18-20 weeks, pregnancy 24-28 weeks, hospitalization during childbirth, six months after delivery.

2. When entering the group(11-13 + 6 weeks of pregnancy): Extraction of blood 10 ~ 15ml to detect relevant metabolic biological indicators in the molecular influence center laboratory of our hospital or the National University of China Gene Company, such as: Asprosin, leptin, etc..

3. Pregnancy 18-20 weeks ago: Extraction of blood 10 ~ 15ml in our laboratory molecular center laboratory to detect related metabolic biological indicators, such as: Asprosin, leptin and so on.

4. Pregnancy 24-28 weeks: draw blood 10 ~ 15ml. Routine clinical examination and examination of OGTT test in our hospital examination department, and the detection of blood lipid and glycosylated hemoglobin. Additional metabolic biomarkers are detected in the central laboratory of molecular in our hospital.

5. Inpatient delivery: routine inpatient blood collection examination, and blood extraction 10 ~ 15ml in our hospital molecular influence center laboratory to detect related metabolic biological indicators, such as: Asprosin, leptin and so on.

6. Six months after delivery: GDM group patients will undergo postpartum review in our hospital, draw blood 10 ~ 15ml in our hospital molecular influence center laboratory to detect related metabolic biological indicators, such as: Asprosin, leptin, etc..

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

1. The items to be collected by newborns: birth weight, length, head circumference, shoulder circumference, abdominal circumference, upper arm circumference, birth style, newborn Apgar score, whether to transfer to Neonatal Intensive Care Unit, Neonatal complications(hypoglycemia, neonatal hypocalcemia, neonatal hyperbilirubinemia, neonatal erythrocytosis, neonatal asphyxia, neonatal respiratory distress syndrome, etc..)

2. Neonatal test: umbilical blood sugar(GDM group only) ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

• NCT number: NCT03825926
• Study type: Observational [Patient Registry]
• Source: Fifth Affiliated Hospital, Sun Yat-Sen University
• Contact: Ming Ye, graduate
• Phone: 0756-2528188
• Email: zdwygcp@126.com
• Status: Recruiting
• Start date: June 1, 2019
• Completion date: December 1, 2025