Clinical trial NCT03279536: Lactoferrin Versus Total Dose Infusion (TDI) For Treating Iron Deficiency Anemia in Pregnancy: Role of Nursing
Official title: Lactoferrin Versus Total Dose Infusion (TDI) For Treating Iron Deficiency Anemia in Pregnancy: Role of Nursing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Iron Deficiency Anemia
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A will receive oral lactoferrin \& group B will receive Total dose infusion
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Pregnant Women aged \>18 years
2. Hemoglobin\<10g/dl
3. Gestational age between 14-28 weeks
4. Singleton pregnancy
5. Willingness to participate and signing the informed consent form

Exclusion Criteria:

1. Anemia predominantly caused by factors other than IDA (e.g. anemia with untreated B12 or foliate deficiency, hemolytic anemia),
2. Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and haemosidrosis).
3. Decompensated liver cirrhosis and active hepatitis (ALAT\>3 times upper limit of normal).
4. Active acute or chronic infections (assessed by clinical judgment supplied with white Blood Cells (WBC) and C - reactive protein (CRP).
5. Rheumatoid arthritis with symptoms or signs of active inflammation.
6. Multiple allergies.
7. Known hypersensitivity to parental iron or any recipients in the investigational drug products.
8. Erythropoietin treatment within 8 weeks prior to the screening visit.
9. Other iron treatment within 8 weeks prior to the screening visit.
10. Planned elective surgery during the study.
11. Participation in any other clinical within 3 months prior to the screening.
12. Any other medical condition e.g. malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus.

Primary outcomes:
measure: the change in Hb concentration
timeFrame: 4- 8 weeks
Secondary outcomes:
measure: measure the change in serum iron, serum ferritin
timeFrame: 4-8 weeks
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Women Health Hospital
Study officials:
affiliation: WHH
name: Warda Helmy, BSN
role: PRINCIPAL_INVESTIGATOR
References: