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Shanghai Clinical Cohort of Hyperglycemia in Pregnancy

Shanghai Clinical Cohort of Hyperglycemia in Pregnancy

Recruiting
18 years and older
Female
Phase N/A

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Overview

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

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 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 Criteria:

  • 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

Study details
    Hyperglycemia in Pregnant Diabetic Patients
    Gestatiaonl Diabetes Mellitus

NCT07161947

Shanghai General Hospital, China

16 October 2025

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