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Subjects were tested for hemoglobin, ferritin, serum iron, transferrin saturation and reticulocyte count during routine prenatal examination at 24-26 weeks of gestation, and blood samples were taken for serum hepcidin detection in the laboratory and the values were recorded. Those who met the criteria were included in the study group, signed the informed consent form and randomized into groups, and were given different drug administration schemes (150mg orally every day, 300mg orally every day, 150mg orally every other day, 300mg orally every other day, intravenous). At the same time, each subject was given anemia diet education, and all subjects were given folic acid 400ug/d and vitamin C 0.5g/d orally during the treatment period. If the subjects were in the oral iron group, the same time of oral iron was determined as 20 o'clock ± 1 hour in the evening, and the oral iron was not taken with other drugs; If the subject is in the intravenous medication group, the medication is scheduled to be administered at a uniform time of 8 o'clock ± 1 hour in the morning. The above subjects were followed up. Hemoglobin, ferritin, serum iron, transferrin saturation and reticulocyte count were performed at 30-32 and 37 weeks of pregnancy and delivery, and blood samples were taken for serum hepcidin detection in the laboratory and the values were recorded. The adverse reactions were investigated with a questionnaire at the last prenatal examination before delivery. After full term delivery, the patient fills in the delivery information and enters it into the database. Finally, the data statistician and the above personnel used the blind method for statistical analysis and reached a conclusion.
Subjects were tested for hemoglobin, ferritin, serum iron, transferrin saturation and reticulocyte count during routine prenatal examination at 24-26 weeks of gestation, and blood samples were taken for serum hepcidin detection in the laboratory and the values were recorded. Those who met the criteria were included in the study group, signed the informed consent form and randomized into groups, and were given different drug administration schemes (150mg orally every day, 300mg orally every day, 150mg orally every other day, 300mg orally every other day, intravenous). At the same time, each subject was given anemia diet education, and all subjects were given folic acid 400ug/d and vitamin C 0.5g/d orally during the treatment period. If the subjects were in the oral iron group, the same time of oral iron was determined as 20 o'clock ± 1 hour in the evening, and the oral iron was not taken with other drugs; If the subject is in the intravenous medication group, the medication is scheduled to be administered at a uniform time of 8 o'clock ± 1 hour in the morning. The above subjects were followed up. Hemoglobin, ferritin, serum iron, transferrin saturation and reticulocyte count were performed at 30-32 and 37 weeks of pregnancy and delivery, and blood samples were taken for serum hepcidin detection in the laboratory and the values were recorded. The adverse reactions were investigated with a questionnaire at the last prenatal examination before delivery. After full term delivery, the patient fills in the delivery information and enters it into the database. Finally, the data statistician and the above personnel used the blind method for statistical analysis and reached a conclusion.
1.1 Oral iron:NIFEREX®(Each granule contains 0.15g of polysaccharide iron complex ,Kremers Urban Pharmaceuticals Inc.
) 1.2 Daily iron supplement scheme (QD):Oral polysaccharide iron complex capsule 150mg/300mg daily.
1.3 Alternative iron supplement scheme(QOD):)Oral polysaccharide iron complex capsule 150mg/300mg every other day 2.1Intravenous iron supplement:Iron Isomaltoside Injection(5ml: 500mg,Wasserburger Arzneimittelwerk GmbH),Intravenous iron supplement
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 150mg QD | Active Comparator | Each subject took vitamin C 1 tablet and 150mg polysaccharide iron complex at 20:00 ± 1 hour every day. |
|
| 150mg QOD | Active Comparator | Each subject took vitamin C 1 tablet and 150mg polysaccharide iron complex at 20:00 ± 1 hour every other day. |
|
| 300mg QD | Active Comparator | Each subject took vitamin C 1 tablet and 300mg polysaccharide iron complex at 20:00 ± 1 hour every day. |
|
| 300mg QOD | Active Comparator | Each subject took vitamin C 1 tablet and 300mg polysaccharide iron complex at 20:00 ± 1 hour every other day. |
|
| Intravenous iron supplement | Active Comparator | Each subject was given intravenous iron supplements according to the instructions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niferex | Drug | Daily iron supplement scheme (QD):Oral polysaccharide iron complex capsule (Niferex)150mg/300mg daily. Alternative iron supplement scheme(QOD):Oral polysaccharide iron complex capsule(Niferex) 150mg/300mg every other day. Intravenous iron supplement(MonoFer):use as instructions |
| Measure | Description | Time Frame |
|---|---|---|
| Ferritin | Concentration of Ferritin in serum in late pregnancy | 37-41 weeks gestation |
| Elevated hemoglobin value | Elevated hemoglobin value between 24 and 41 weeks of gestation | 37-41 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin | Concentration of Hemoglobin value in whole blood | 20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation |
| ferritin | Concentration of ferritin value in serum |
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Inclusion Criteria:
Exclusion Criteria:
Women of childbearing age who can be pregnant
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang Zhiwei, PH.D | Contact | 13953109309 | zzw_sun@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhang Zhiwei, PH.D | Qianfoshan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Qianfoshan Hospital | Recruiting | Jinan | Shandong | China |
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| ID | Term |
|---|---|
| D006432 | Hemochromatosis |
| ID | Term |
|---|---|
| D008664 | Metal Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C078972 | Niferex |
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|
|
| 20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation |
| serum iron | Concentration of serum iron value in serum | 20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation |
| transferrin saturation | Concentration of transferrin saturation value in serum | 20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation |
| total iron binding force | total iron binding force in serum | 20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation |
| reticulocyte count | reticulocyte count in whole blood | 20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation |
| Correction rate of iron deficiency anemia during pregnancy | Correction rate of ferritin deficiency | 37-41 weeks gestation |
| Adverse reaction rate | Rate of Adverse reaction such as Vomiting, nausea, constipation, diarrhea or allergy | 37-41 weeks gestation |
| Correction rate of ferritin deficiency | Correction rate of ferritin deficiency | 37-41 weeks gestation |
| D019190 | Iron Overload |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |