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

NCT03825926 | Unknown

• 1 other identifier: ZDWY.CK.001
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Age: 18-40 years old. The age is determined by the date of birth and the expected date of birth of the identity card.
• Age of entry into the group: Before 16 weeks of pregnancy. The determination of pregnancy week refers to the Hyperglycemia and Adverse Pregnancy Outcomes research report method. Specifically, first, if the pregnant woman's menstruation is regular, the pregnancy week is calculated according to the last menstrual time. If the menstruation is irregular or the last period can not be determined, the pregnancy week is calculated using B-ultrasound results during the period of 6-24 weeks. Second, if menstruation is regular, but there is a large difference with the B-super estimated expected date of delivery, it is more than 5 days different from the 6-13 weeks B-super result, or more than 10 days different from the 14-24 weeks result, still correcting the pregnancy week according to the B-super result.
• Number of pregnancies: This study does not limit the number of pregnancies. In order to improve consistency and compare with previous studies, all those who entered the group were single pregnancies.
• Prenatal examination: In order to improve the consistency of the study, the patients in the group were all examined regularly in our hospital, and the important laboratory results accepted by the research institute were all conducted in our hospital.

You may not qualify if:

• Pregnancy week: At the time of the visit, the pregnancy week has exceeded 24 weeks, or the pregnancy week can not be determined.
• Pregnancy mode: unnatural pregnancy(including ovulatory drugs, test-tube infants, etc.).
• Diabetes combined with pregnancy: previously diagnosed diabetes; Or early pregnancy fasting blood sugar ≥ 7.0 mmol/L and diagnosed diabetes combined pregnancy; Or by other situations(random blood sugar \> 11.1 mmol/L with diabetes symptoms) Diagnosis of diabetes combined with pregnancy.
• As a result of the combination of other diseases, drugs that affect glucose metabolism, such as glucocorticoids and diuretics, are being taken.
• Combine other diseases that affect sugar metabolism, such as hyperthyroidism, history of polycystic ovary syndrome, etc..
• Because the target population in this study is a normal population, people with high risk factors for GDM will be excluded: such as the family history of type 2 diabetes, the history of huge childbirth, the past pregnancy combined with GDM, and obesity(BMI≥30kg/m2), poor maternity history, etc..
• Those who do not agree to draw blood before 24 weeks of pregnancy.

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

the Fifth Affiliated Hospital of Sun Yat-sen University of Gynaecology and Obstetrics

Zhuhai, Guangdong, 519000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood and placenta, umbilical cord endothelial tissue and umbilical cord blood after the delivery

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Zhaojuan Su, postgraduate

  Fifth Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Ming Ye, graduate

CONTACT

0756-2528188; zdwygcp@126.com

Yuhang Long, postgraduate

CONTACT

13763379833; longyh7@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 1, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

CN (1)