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The influence of insulin therapy on the maternal and infant outcomes of patients with gestational diabetes mellitus

The influence of insulin therapy on the maternal and infant outcomes of patients with gestational diabetes mellitus

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104279
Enrollment
Unknown
Registered
2025-06-13
Start date
2024-01-01
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

Gestational diabetes mellitus

Interventions

Experimental group:One-day outpatient treatment for diabetes combined with insulin therapy
Control group:Lifestyle intervention

Sponsors

The Fourth Hospital of Shijiazhuang
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1 Meeting the diagnostic criteria for GDM: Oral administration of 75g anhydrous glucose for glucose tolerance test (OGTT) at 24-28 weeks of pregnancy. (1) Fasting blood glucose >= 5.1mmol/L,(2) 1-hour blood glucose >= 10.0 mmol/L,(3) 2-hour blood glucose >= 8.5mmol/ L. If any of the above conditions are met, it can be diagnosed as GDM. 2 Age: 20-40 years old; 3 Natural singleton pregnancy;

Exclusion criteria

Exclusion criteria: 1 Meeting the diagnostic criteria for diabetes mellitus complicated with pregnancy: According to the guidelines issued by the American Diabetes Association (ADA) in 2011, if the fasting blood glucose (FPG) at the first pregnancy examination is >= 7.0 mmol/L or the glycated hemoglobin (HbA1C) is >= 6.5% or the random blood glucose is >= 11.1 mmol/L and there are symptoms, it is diagnosed as diabetes mellitus complicated with pregnancy. 2 Accompanied by other pregnancy complications before participating in the study; 3 Those who had diabetes, hyperlipidemia, hypertension and other diseases before pregnancy; 4 Those with incomplete data or who refuse to participate in the research, combined with mental disorders, and have difficulty cooperating with blood collection.

Design outcomes

Primary

MeasureTime frame
Blood lipid;Glycated hemoglobin;Fasting insulin;Fasting blood glucose;Postpartum OGTT and insulin release assay;

Secondary

MeasureTime frame
Body weight;

Countries

China

Contacts

Public ContactMin Ma

The Fourth Hospital of Shijiazhuang

maminhappy@163.com+86 159 3018 1760

Outcome results

None listed

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