Pregnancy anemia
Conditions
Interventions
Experimental group:Compound E Jiao Jiang+Ferrous Succinate Tablets
Control group:The placebo of compound E Jiao Jiang+Ferrous Succinate Tablets
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1) Age between 18 and 35 years old (including 18 and 35 years old); 2) Meet the diagnostic criteria for iron-deficiency anemia during pregnancy, according to the "Guidelines for the Diagnosis and Treatment of Iron Deficiency and Iron-Deficiency Anemia during Pregnancy" and recommendations from the World Health Organization. The diagnostic criteria for iron-deficiency anemia during pregnancy are: Hemoglobin (Hb) <110 g/L and serum ferritin (SF) <20 µg/L. According to Hb concentration, it is classified as mild anemia (100-109 g/L), moderate anemia (70-99 g/L), severe anemia (40-69 g/L), and very severe anemia (<40 g/L); 3) Anemia severity is classified as mild or moderate; 4) Gestational age between 24 and 32 weeks; 5) Singleton pregnancy with fetal growth consistent with gestational age; 6) Voluntarily sign the informed consent form for the study participant.
Exclusion criteria
Exclusion criteria: 1) Anemia caused by trauma, acute or chronic diseases, or malignant tumors; 2) Individuals with previous coagulation disorders or hematological diseases (such as sickle cell anemia, thalassemia, aplastic anemia, myelodysplastic syndrome, acute leukemia, etc.); 3) Complications during pregnancy, such as severe gestational diabetes or severe gestational hypertension; 4) Individuals with previous digestive system diseases (such as gastric or duodenal ulcers, gastritis, enteritis, etc.); 5) High-risk pregnancies, such as placenta previa or placental abruption; 6) Individuals diagnosed with anemia before pregnancy; 7) Individuals who have received intravenous iron supplementation, erythropoiesis-stimulating agents, or blood transfusions within 4 weeks before screening; and individuals who have taken oral iron supplements or herbal medicines with blood-tonifying effects within 7 days before screening; 8) Severe liver or kidney dysfunction (alanine aminotransferase (ALT) >1.5×ULN, aspartate aminotransferase (AST) >1.5×ULN, blood urea nitrogen (BUN) >2×ULN, creatinine (Cr) >1×ULN), cardiovascular or hematological diseases; 9) Individuals with mental or neurological disorders; 10) Individuals with contraindications for iron supplementation; 11) Individuals with known allergies to iron preparations or the known components of compound donkey-hide gelatin syrup; 12) Individuals who have participated in other clinical trials within the past 3 months before screening; 13) Individuals deemed unsuitable for participation in this study by the clinical doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with Hb = 110 g/L;Health related quality of life score;The Functional Assessment of Chronic Illness Therapy–Fatigue;Pittsburgh Sleep Quality Index;Serum ferritin;Mean corpuscular volume;Mean corpuscular hemoglobin;Traditional Chinese Medicine Syndrome Score; | — |
Countries
China
Contacts
Public ContactWei Yuan
Peking University Third Hospital
Outcome results
None listed