Early detection and follow-up of gestational diabetes in pregnant women

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

This study is testing a new way to spot and keep track of gestational diabetes in pregnant women to help manage their health better during and after pregnancy.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University (Academic / other)
• Locations: 1 site (Zhuhai, Guangdong)
• Trial ID: NCT03825926 on ClinicalTrials.gov

What this trial studies

This study focuses on the early screening of gestational diabetes mellitus (GDM) in pregnant women by extracting whole blood at 24 weeks of pregnancy. It aims to create a comprehensive database for managing and following up with pregnant women diagnosed with GDM, ensuring consistent monitoring and adherence to clinical guidelines. The study involves multiple data collection points throughout pregnancy and postpartum to assess maternal and metabolic outcomes. A dedicated research assistant will oversee the maternity examinations and follow-ups to maintain standardized care.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women aged 18-40 who are less than 16 weeks pregnant.

Not a fit: Patients who are outside the age range of 18-40 or who are already diagnosed with gestational diabetes prior to the study will not benefit.

Why it matters

Potential benefit: If successful, this study could lead to improved maternal and fetal health outcomes through early intervention for gestational diabetes.

How similar studies have performed: Other studies have shown success in early screening and management of gestational diabetes, indicating that this approach is supported by existing evidence.

Eligibility criteria

Inclusion Criteria:

1. Age: 18-40 years old. The age is determined by the date of birth and the expected date of birth of the identity card.
2. 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.
3. 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.
4. 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 Criteria:

1. Pregnancy week: At the time of the visit, the pregnancy week has exceeded 24 weeks, or the pregnancy week can not be determined.
2. Pregnancy mode: unnatural pregnancy(including ovulatory drugs, test-tube infants, etc.).
3. 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.
4. As a result of the combination of other diseases, drugs that affect glucose metabolism, such as glucocorticoids and diuretics, are being taken.
5. Combine other diseases that affect sugar metabolism, such as hyperthyroidism, history of polycystic ovary syndrome, etc..
6. 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..
7. Those who do not agree to draw blood before 24 weeks of pregnancy.

Where this trial is running

Zhuhai, Guangdong

• the Fifth Affiliated Hospital of Sun Yat-sen University of Gynaecology and Obstetrics — Zhuhai, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Ming Ye, graduate

Conditions Gestational Diabetes Mellitus