Status:
RECRUITING
Shanghai Clinical Cohort of Hyperglycemia in Pregnancy
Lead Sponsor:
Shanghai General Hospital, China
Collaborating Sponsors:
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai First Maternity and Infant Hospital
Conditions:
Hyperglycemia in Pregnant Diabetic Patients
Gestatiaonl Diabetes Mellitus
Eligibility:
FEMALE
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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 pregnancy
- Age ≥18 years at the time of consent
- Willing and able to attend postpartum assessments (OGTT at 6 weeks, 12 months, and annually thereafter), with planned follow-up ≥3 years
Exclusion
- Current or history of illicit drug use or substance abuse
- Presence of an active infectious disease, including but not limited to: viral hepatitis, sexually transmitted infections or tuberculosis
- Any other condition which, in the judgment of the investigator, would make the subject unsuitable for enrollment in the study
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT07161947
Start Date
April 1 2025
End Date
December 31 2027
Last Update
September 9 2025
Active Locations (1)
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1
Shanghai General Hospital, China
Shanghai, Shanghai Municipality, China, 200080