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NCT Number: NCT07161947

Shanghai Clinical Cohort of Hyperglycemia in Pregnancy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Shanghai General Hospital, China

Shanghai, Shanghai Municipality, 200080, China

Location status: Recruiting

Location contact

Yufan Wang, PhD

CONTACT

[email protected]

(+86) 021-63240090

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Primary outcomes

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

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

    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.

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

    Time frame: 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.

    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.

Secondary outcomes

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

    Time frame: 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.

    Unit of Measure: Percentage of patients with abnormal Hemoglobin A1c (HbA1c, %) Description: This measure will assess the incidence of abnormal glucose metabolism based on HbA1c testing. Abnormal glucose metabolism will be defined as an HbA1c ≥6.5%.

    Data will be collected from blood tests and medical records.

Study contacts

Contact information is provided by the study sponsor or research team.

Yufan Wang, PhD

CONTACT

[email protected]

(+86) 021-63240090

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, China

Other

Collaborators

  • RenJi Hospital
  • Shanghai First Maternity and Infant Hospital
  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Registry information

Official study title

Shanghai Clinical Cohort-Hyperglycemia in Pregnancy (Reserved)

Acronym: SHINE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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