Shanghai Clinical Cohort of Hyperglycemia in Pregnancy

NCT ID: NCT07161947

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-12-31

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.

Conditions

Hyperglycemia in Pregnant Diabetic Patients; Gestatiaonl Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: collaborator

Shanghai General Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Yufan Wang

Chief Physician, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai General Hospital, China

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yufan Wang, PhD

Role: CONTACT

yyffwang@sina.com

(+86) 021-63240090

Facility Contacts

Yufan Wang, PhD

Role: primary

yyffwang@sina.com

(+86) 021-63240090

Other Identifiers

SHDC2025CCS041

Identifier Type: -

Identifier Source: org_study_id