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Study Procedures:
All patients will undergo the following:
Informed consent will be obtained from all the participants in this study before enrolling in this study and all participants will be subjected to a detailed clinical assessment including: a detailed history, general, abdominal examinations, Investigations.
History taking:
Medical examination:
Investigations to perform will include:
Laboratory: Complete blood count (microcytic hypochromic anemia) Imaging: Ultrasound to assess biometry to exclude fetal growth restriction. Women will be divided in two groups with 20 in each group, the first group will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks and the second group will receive lactoferrin sachets 100mg with ferrous gluconate 300mg twice per day for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules.
Women will be told to record side effects as nausea, vomiting, abdominal discomfort and constipation.
Women will have a blood sample (CBC) withdrawn after 2 to 4 weeks to assess rise in pregnant anemia.
This study included two groups:
Group I: 20 patients were given ferrous gluconate 300 mg (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily.
Group II: 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.
hematological parameters (rise in hemoglobin) and the adverse effects of both drugs were studied at registration and after 4 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group I | Active Comparator | the first group 20 patients will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily. |
|
| group II | Active Comparator | 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous Gluconate 300 MG | Drug | iron salt one tab 300 mg contain 35 mg of elemental iron given 2 doses 600 mg per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| • Hemoglobin (Hb) level | hemoglobin will be measured before and after treatment by 4 weeks (HB in gm/dl) | 4 weeks |
| serum ferritin | serum ferritin will be measured before and after treatment by 4 weeks (ferritin in ug/l ) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| gastrointestinal side effects | (nausea , vomiting , constipation ) will be assessed before and after treatment | 4 weeks |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AMR Saad, doctoral | faculty of medicine Ain shams university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university maternity hospital | Cairo | 6825344 | Egypt |
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Total 40 females from 14 to 35 weeks of pregnancy with Hemoglobin level between 8.5 to 10.5 gm/dl, recruited from the obstetric inpatient/outpatient clinic at Ain Shams University, Maternity hospital.
This study included two groups:
Group I: 20 patients were given ferrous gluconate 300 mg (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily.
Group II: 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.
hematological parameters (rise in hemoglobin) and the adverse effects of both drugs were studied at registration and after 4 weeks
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| ferrous gluconate with lactoferrin | Drug | Lactoferrin is a glycoprotein from the transferrin family consist of 691 amino acids,Lactoferrin is a protein found in cow milk and human milk |
|
|
| ID | Term |
|---|---|
| C011819 | ferrous gluconate |
| D007781 | Lactoferrin |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D061250 | Transferrins |
| D033862 | Iron-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007782 | Lactoglobulins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005916 | Globulins |
| D008667 | Metalloproteins |
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