Lactoferrin Versus Total Dose Infusion (TDI) For Treating Iron Deficiency Anemia in Pregnancy: Role of Nursing

Study Overview
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Brief Summary
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This study consisted of 60 cases. All the cases of pregnant women are 4 months to 8 months of pregnancy. The cases divided into 30 pregnant women's were given iron supplementation without health education and another 30 were given iron supplementation and health education for comparison between them. Comparative between hemoglobin levels before and after medication. Treatment of iron deficiency anemia with iron supplementation received for one month.

Detailed Description
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The investigator will divide the participants into two groups e.g. group (A) and group (B) according to Hemoglobin level and receiving of oral supplementation for IDA accompanied with health education in case of group (A) and without health education in case of group (B). Then the investigator asked patient to sign the document of her investigations result to receive iron supplementation. After that, the investigator observes hemoglobin's Level, when it less than >11g/dl, the patient will be the group (A) who will receive oral iron supplementation and health education. Group (B) who will receive Total Dose Infusion (TDI) without health education.

Official Title
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Lactoferrin Versus Total Dose Infusion (TDI) For Treating Iron Deficiency Anemia in Pregnancy: Role of Nursing

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Combination Product: Oral lactoferrin
* Combination Product: TDI of LMW iron dextran


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant Women aged >18 years Hemoglobin<10g/dl Gestational age between 14-28 weeks Singleton pregnancy Willingness to participate and signing the informed consent form Exclusion Criteria: Anemia predominantly caused by factors other than IDA (e.g. anemia with untreated B12 or foliate deficiency, hemolytic anemia), Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and haemosidrosis). Decompensated liver cirrhosis and active hepatitis (ALAT>3 times upper limit of normal). Active acute or chronic infections (assessed by clinical judgment supplied with white Blood Cells (WBC) and C - reactive protein (CRP). Rheumatoid arthritis with symptoms or signs of active inflammation. Multiple allergies. Known hypersensitivity to parental iron or any recipients in the investigational drug products. Erythropoietin treatment within 8 weeks prior to the screening visit. Other iron treatment within 8 weeks prior to the screening visit. Planned elective surgery during the study. Participation in any other clinical within 3 months prior to the screening. Any other medical condition e.g. malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A will receive oral lactoferrin & group B will receive Total dose infusion
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Lactoferrin<br>Group A is 120 mg of Oral lactoferrin for 4 weeks Intervention: The participants 66 will receive oral Lactoferrin 120mg for 4 weeks | Combination Product: Oral lactoferrin<br>* Oral lactoferrin 120 mg twice /day and it's based on fast dissolving through direct swallowing per oral route with fruits flavor taste.<br>* Other names: Oral Fizzing Lactoferrin;|
| Active Comparator: Total dose infusion (TDI) iron dextran<br>Group B is a parenteral total dose infusion (TDI) of LMW iron dextran 20mg/kg body weight for 4 weeks Intervention: The participants 33 will receive parental iron 20mg/kg body weight for 4 weeks | Combination Product: TDI of LMW iron dextran<br>* Total Dose Infusion of LMW iron dextran up to 20mg/kg body weight is infused intravenously<br>* Other names: Parental dextran;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change in Hb concentration | measure the change in Hb concentration from baseline to week 4 after oral Lactoferrin treatment and relieve of symptoms of anemia | 4- 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure the change in serum iron, serum ferritin | measure the change in serum iron, serum ferritin based on comparison between oral lactoferrin with health education & TDI from hospital routine care. | 4-8 weeks |