Shanghai cohort for high blood sugar during pregnancy

Shanghai Clinical Cohort-Hyperglycemia in Pregnancy (Reserved)

This project will follow pregnant people with high blood sugar or at high risk for gestational diabetes to test subtype-specific standards for diagnosis, treatment, and follow-up from before pregnancy through postpartum.

Quick facts

• Study type: Observational
• Enrollment: 4000 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Shanghai General Hospital, China (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07161947 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Pregnant individuals able to give written consent who have GDM by CDS 2024 OGTT thresholds, documented pre-gestational diabetes, or meet defined high-risk criteria (for example prior GDM, prior macrosomic infant, BMI ≥24 kg/m², family history, or PCOS) are ideal candidates.

Not a fit: People without hyperglycemia or the listed risk factors, and those unable to attend required clinic visits in Shanghai, are unlikely to receive direct benefit from participation.

Why it matters

Potential benefit: If successful, this work could produce tailored care guidelines that reduce pregnancy complications and improve long-term health for mothers and babies.

How similar studies have performed: Previous pregnancy cohorts have expanded understanding of gestational diabetes and its outcomes, but comprehensive subtype-specific, end-to-end clinical standards like those proposed here remain relatively novel and not yet widely validated.

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 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 this trial is running

Shanghai, Shanghai Municipality

• Shanghai General Hospital, China — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yufan Wang, PhD

Conditions Hyperglycemia in Pregnant Diabetic Patients; Gestatiaonl Diabetes Mellitus