Sponsor study identifier
observational
600
1 country
1
Study Start
June 1, 2019
Actual (reported)Primary Completion
June 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 24, 2019
Actual (reported)February 1, 2019
Actual (reported)June 1, 2019
Actual (reported)June 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
New biomarkers levels in different pregnant weeks
1. Collect time: We will collect our sample in different pregnant weeks such as 11-13+6 weeks as early pregnancy, 18-20 weeks as compared mid-pregnancy, 24-28 weeks as the criteria mid-pregnancy, delivery weeks as the first outcome and 6 months after delivery time as the second outcome. This will be helpful to evaluate the criteria and explore pregnant glycolipid metabolism at new sight. 2. Sample details: we will collect maternal blood for different pregnant weeks, neonatal cord blood, umbilical cord endothelial tissue and placenta after sign informed consent. All maternal and neonatal sample will tested the first step of new biomarkers by quantitative analysis methods such as mass spectrometers, immunohistochemistry and enzyme linked immunosorbent assay and so on. we will explore the changed range on those new biomarkers during early-mid-late pregnancy.
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).
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
Expenditure on health products and drugs before diagnosed GDM
before 13+6 weeks as the first time, before the diagnosis of GDM as the second time
Expenditure on GDM after the diagnosis
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
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.
normal group
1. Inform interviewees who meet the requirements for access of the relevant research content and risks, obtain their consent, and sign the informed consent. 2. pregnant women during the birth test, pregnancy 11 \~ 13 + 6 weeks and pregnancy 18-20 weeks, respectively, 10 \~ 15ml. 3. Clinical blood samples will also be recovered for scientific purposes during 24-28 weeks of routine delivery and prior to delivery in hospital. 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.
the Fifth Affiliated Hospital of Sun Yat-sen University of Gynaecology and Obstetrics
Zhuhai, Guangdong, 519000, China
whole blood and placenta, umbilical cord endothelial tissue and umbilical cord blood after the delivery
Zhaojuan Su, postgraduate
Fifth Affiliated Hospital, Sun Yat-Sen University
First Submitted
January 24, 2019
First Posted
February 1, 2019
Study Start
June 1, 2019
Actual (reported)Primary Completion
June 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Early Diagnosis of GDM by Multiomics
Contact the study team to confirm eligibility.
Study Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 31, 2020
Record last verified: 2020-03
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