Gestational diabetes
Conditions
Interventions
Experimental group:Basic treatment + Polysaccharide Iron Complex Capsules
Specific usage and dosage:
Polysaccharide Iron Complex Capsules: Adults take one capsule orally once daily.
Sponsors
The First Affiliated Hospital of Hebei North University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for gestational diabetes mellitus complicated with anemia, with anemia severity being mild or moderate. (2) Singleton pregnancy. (3) Aged 18–40 years (inclusive), at 24–32 weeks of gestation (inclusive). (4) Understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with iron overload, hemochromatosis, or hemosiderosis. (2) Anemia caused by acute or chronic infections, severe malnutrition, myelofibrosis, etc. (3) Patients with allergic constitution or allergy to this drug. (4) Patients with severe gestational diabetes (e.g., glycated hemoglobin >6%), severe gestational hypertension syndrome (e.g., systolic blood pressure >=160 mmHg, diastolic blood pressure >=110 mmHg), or other pregnancy complications, or those whose blood glucose or lipids remain poorly controlled after taking hypoglycemic or lipid-lowering drugs. (5) Patients with severe cardiovascular or cerebrovascular diseases, liver system diseases, tumors; those in a state of infection or inflammation; patients with bleeding tendency, mental illness, or severe speech and cognitive impairment. (6) Patients with high-risk pregnancies such as placenta previa or placental abruption. (7) Patients who have received intravenous iron therapy, erythropoiesis-stimulating agents, or blood transfusion within 4 weeks before screening; or those who have received oral iron or iron-containing preparations within 7 days before screening. (8) Patients who have participated in other drug clinical trials within 3 months before joining this trial or are currently participating in other clinical trials. (9) Patients considered unsuitable for clinical trial participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin (HbA1c);Hemoglobin (Hb);Fasting blood glucose;Iron metabolism indicators: Transferrin saturation (TSAT), serum iron (SI), serum ferritin (SF);Quality of Life Scale (SF?12);Proportion and timing of rescue therapy (including blood transfusion, use of ESAs, intravenous iron, etc.); | — |
Countries
China
Contacts
Public ContactXu Zhengrong
The First Affiliated Hospital of Hebei North University
Outcome results
None listed