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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
452
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
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
RECRUITINGFerritin
Concentration of Ferritin in serum in late pregnancy
Time frame: 37-41 weeks gestation
Elevated hemoglobin value
Elevated hemoglobin value between 24 and 41 weeks of gestation
Time frame: 37-41 weeks gestation
Hemoglobin
Concentration of Hemoglobin value in whole blood
Time frame: 20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
ferritin
Concentration of ferritin value in serum
Time frame: 20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
serum iron
Concentration of serum iron value in serum
Time frame: 20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
transferrin saturation
Concentration of transferrin saturation value in serum
Time frame: 20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
total iron binding force
total iron binding force in serum
Time frame: 20-24 weeks gestation,30-32 weeks gestation,37-41 weeks gestation
reticulocyte count
reticulocyte count in whole blood
Time frame: 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
Time frame: 37-41 weeks gestation
Adverse reaction rate
Rate of Adverse reaction such as Vomiting, nausea, constipation, diarrhea or allergy
Time frame: 37-41 weeks gestation
Correction rate of ferritin deficiency
Correction rate of ferritin deficiency
Time frame: 37-41 weeks gestation
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