Status:
UNKNOWN
Early Screening of Gestational Diabetes Mellitus and Prospective Cohort Study of Postpartum Follow-up
Lead Sponsor:
Fifth Affiliated Hospital, Sun Yat-Sen University
Conditions:
Gestational Diabetes Mellitus
Eligibility:
FEMALE
18-50 years
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 ...
Detailed 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 repo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03825926
Start Date
June 1 2019
End Date
December 1 2025
Last Update
March 31 2020
Active Locations (1)
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1
the Fifth Affiliated Hospital of Sun Yat-sen University of Gynaecology and Obstetrics
Zhuhai, Guangdong, China, 519000