NCT07161947 Shanghai Clinical Cohort of Hyperglycemia in Pregnancy
| NCT ID | NCT07161947 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai General Hospital, China |
| Condition | Hyperglycemia in Pregnant Diabetic Patients |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,000 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2027-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Establish a high-quality clinical cohort of hyperglycemia in pregnancy. Develop subtype-specific, end-to-end standards for diagnosis, treatment, and follow-up across the preconception, pregnancy, and postpartum phases. These standards will lay a solid foundation for efficient, high-quality clinical research.
Eligibility Criteria
Inclusion Criteria: * Pregnant individuals who provide written informed consent * At enrollment, meet one of the following: 1\. Gestational diabetes mellitus (GDM) diagnosed by a 75-g oral glucose tolerance test (OGTT) using Chinese Diabetes Society (CDS) 2024 thresholds (any one of: fasting plasma glucose ≥5.1 mmol/L, 1-h ≥10.0 mmol/L, or 2-h ≥8.5 mmol/L); or 2. Pre-gestational diabetes (type 1 or type 2) documented prior to pregnancy or meeting diabetes criteria at the first prenatal visit (e.g., fasting ≥7.0 mmol/L, 2-h OGTT ≥11.1 mmol/L, or HbA1c ≥6.5%); or 3. At high risk for GDM, defined a priori as ≥1 of the following: prior GDM; prior macrosomic infant (≥4,000 g); pre-pregnancy BMI ≥24 kg/m²; age ≥45 years; high-density lipoprotein cholesterol \<1 mmol/L, and/or triglyceride levels \>2.8 mmol/L; first-degree family history of diabetes; polycystic ovary syndrome (PCOS); history of coronary heart disease; chronic hypertension and repeated positive fasting urinary glucose in early