Shanghai Clinical Cohort of Hyperglycemia in Pregnancy

NCT07161947 | Recruiting

• 1 other identifier: SHDC2025CCS041
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Composite Adverse Maternal and Neonatal Outcomes Among Pregnant Individuals With Hyperglycemia in Pregnancy

  Unit of Measure: Percentage of pregnancies with ≥ 1 event (%) Description: The composite will be coded as Yes/No. An event is counted if any of the following occurs: preeclampsia, cesarean delivery, premature rupture of membranes, placental abruption, preterm birth, congenital malformations, macrosomia, large for gestational age, small for gestational age, neonatal hypoglycemia, neonatal hyperbilirubinemia, neonatal respiratory distress syndrome, neonatal intensive care unit admission, obstetric trauma or still birth. Data abstracted from electronic medical records.

  From delivery (Day 0) through the initial birth hospitalization, assessed up to 14 days postpartum.

• Postpartum Glucose Metabolism Outcomes Among Pregnant Individuals With Hyperglycemia in Pregnancy (OGTT)

  Unit of Measure: Percentage of patients with abnormal glucose metabolism based on OGTT (%) Description: This measure will assess the incidence of abnormal glucose metabolism using an oral glucose tolerance test (OGTT). Abnormal glucose metabolism will be defined as: fasting glucose ≥6.1 mmol/L or 2-hour glucose ≥7.8 mmol/L. Data will be collected from blood tests and medical records.

  From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 10 years postpartum.

Secondary Outcomes (1)

• Postpartum Glucose Metabolism Outcomes Among Pregnant Individuals With Hyperglycemia in Pregnancy (HbA1c)

  From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 10 years postpartum.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will enroll patients who receive routine prenatal care, deliver, and undergo postpartum endocrinology follow-up at any of the following four hospitals: Shanghai General Hospital; Shanghai First Maternity and Infant Hospital; Renji Hospital, Shanghai Jiao Tong University School of Medicine; and Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University.

You may qualify if:

• Pregnant individuals who provide written informed consent
• At enrollment, meet one of the following:
• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai General Hospital, China: lead
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator
• Shanghai First Maternity and Infant Hospital: collaborator
• RenJi Hospital: collaborator

Study Sites (1)

Shanghai General Hospital, China

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum/Plasma, Adipose Tissue, Placenta

Central Study Contacts

Yufan Wang, PhD

CONTACT

(+86) 021-63240090; yyffwang@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 9, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

CN (1)