Shanghai Clinical Cohort of Hyperglycemia in Pregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorShanghai General Hospital, China
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant individuals who provide written informed consent
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
From delivery (Day 0) through the initial birth hospitalization, assessed up to 14 days postpartum.2
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.
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.Secondary outcomes
1
Postpartum Glucose Metabolism Outcomes Among Pregnant Individuals With Hyperglycemia in Pregnancy (HbA1c)
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.
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.Sponsors and contacts
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Shanghai General Hospital, China
Lead sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Collaborator
Shanghai First Maternity and Infant Hospital
Collaborator
RenJi Hospital
Collaborator
Source ClinicalTrials.gov