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To validate and optimize a new clinical scoring system for maturity-onset diabetes of the young in women with hyperglycemia during pregnancy

To validate and optimize a new clinical scoring system for maturity-onset diabetes of the young in women with hyperglycemia during pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400094700
Enrollment
Unknown
Registered
2024-12-26
Start date
2021-10-30
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia in pregnancy

Interventions

Gold Standard:Genetic analysis and the above method is required
Index test: Clinical model scoring

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1)Preconceptional individuals diagnosed with diabetes, including those planning for pregnancy and those with pre-existing pregestational diabetes mellitus (PGDM), undergo medical history collection and relevant parameter assessments during preconception counseling or the first antenatal visit. Diabetes is diagnosed if any of the following conditions are met: fasting blood glucose (FBG) >=7mmol/L; immediate blood glucose or postprandial 2-hour blood glucose (BG) >=11.1mmol/L; or hemoglobin A1c (HbA1c) >=6.5%. 2)Preconceptionally diagnosed individuals with impaired glucose tolerance (IGT), impaired fasting glucose (IFG), or classified as high-risk according to the ADA guidelines (meeting any of the following high-risk criteria: a. FBG >=5.6mmol/L; b. HbA1c >=5.7%; c. history of IFG or IGT; d. first-degree relative with diabetes history; e. history of gestational diabetes mellitus (GDM) or recurrent adverse obstetric outcomes) should undergo diabetes screening (HbA1c, FBG, or 2-hour oral glucose tolerance test) during preconception counseling or the first antenatal visit. 3)All pregnant women not diagnosed with diabetes between 24-28 weeks of gestation undergo a 75g oral glucose tolerance test (OGTT), and gestational diabetes mellitus (GDM) is diagnosed according to the IAPDSG criteria (not lower than any of the following threshold values: 0-hour 5.1mmol/L; 1-hour 10.0mmol/L; 2-hour 8.5 mmol/L).

Exclusion criteria

Exclusion criteria: 1)Preconceptional individuals with obesity (pre-pregnancy BMI >=28kg/m^2); 2)Individuals with secondary diabetes mellitus with a clear etiology, such as those following corticosteroid use, a history of pancreatitis, etc.

Design outcomes

Primary

MeasureTime frame
Clinical model scoring;

Secondary

MeasureTime frame
Positive predictive value;Specificity;Negative predictive value;Sensitivity;

Countries

China

Contacts

Public ContactFan Ping

Peking Union Medical College Hospital

pingfan6779@163.com+86 136 5109 1819

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026