Shanghai cohort for high blood sugar during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, multi-center clinical cohort enrolling pregnant individuals with gestational diabetes, pre-gestational diabetes, or predefined high risk for GDM. Participants will provide written consent and undergo standardized clinical data collection, laboratory testing (including OGTT and HbA1c), and longitudinal follow-up across preconception (when applicable), pregnancy, and the postpartum period. The program aims to define disease subtypes and to develop end-to-end, subtype-specific standards for diagnosis, management, and follow-up. The resulting dataset and standards are intended to create a foundation for more efficient, higher-quality clinical research and care pathways.

Why it matters

Who can join: the full rules

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

Where it's running

• Shanghai General Hospital, China
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Yufan Wang, PhD
• Email: yyffwang@sina.com
• Phone: (+86) 021-63240090

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gongji Pregnancy Endocrine Cohort

  This project will try to see how genes, lifestyle, and medications relate to gestational diabetes and thyroid problems and their effects on pregnancy and the first year after birth for women planning pregnancy, pregnant, or within one year postpartum.

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• Core Canister Training for pregnant women with gestational diabetes

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• Lumbopelvic Stability in Gestational Diabetes Mellitus

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  Recruiting Riphah International University · Lahore, Punjab Province · NCT07851753

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.