The Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant
Primary Purpose
Anemia of Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Iron
Complete blood count
Serum ferritin
Serum hepcidin
Serum Iron
Serum total iron binding capacity
Sponsored by
About this trial
This is an interventional prevention trial for Anemia of Pregnancy
Eligibility Criteria
Inclusion Criteria:
- Pregnant woman in a singleton pregnancy (12-14 weeks).
- BMI (30- 40 kg/m2).
- Normal hemoglobin level (>11 g/dL).
- Normal hematocrit (Hct 31-41%).
- Normal ferritin level (6-130 ng/mL).
- Women willingness to participate in the study.
- Women living in the nearby area to make follow-up visits possible.
Exclusion Criteria:
- Multiple gestations.
- Women received a recent blood transfusion.
- Women with threatened miscarriage.
- Women are known to have pathological blood loss.
- Intolerant to oral iron form.
- History of the hematologic disorder.
- Women used iron in the past 3 months.
- Women with chronic diseases (hypertension, diabetes, renal diseases, thyroid disease……).
Sites / Locations
- Woman's Health Hospital - Assiut university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group I: 27 mg elemental iron
Group II: 54 mg elemental iron
Arm Description
will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks
will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks
Outcomes
Primary Outcome Measures
The number of anemic women at time of delivery
Secondary Outcome Measures
The mean level of maternal Hemoglobin at 37-38 weeks .
The incidence of patients' reported side effect
The difference in serum ferritin
The difference in serum hepcidin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04101461
Brief Title
The Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant
Official Title
The Effectiveness of Single Versus Double Daily Dose of Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Anemia is known as a condition in which the hemoglobin level is lower than normal. Anemia is one of the most common complications during pregnancy. Anemia in pregnancy is defined as a hemoglobin level < 110 g/L . Anemia is an important risk factor in pregnancy which leads to both maternal and fetal morbidity and mortality.
The pregnant woman needs more iron during pregnancy, so iron deficiency anemia is very common during pregnancy. In Egypt; iron deficiency anemia affects about one in every two pregnant women, especially in rural areas. Pregnant women require about 27 mg/day elemental iron to cover their increased need. The pregnant women should start taking a daily supplement of 30mg of elemental iron as a preventive measure against iron deficiency anemia especially in poor countries.
Obesity is defined as having an excessive amount of body fat. The body mass index, a measurement based on height and weight, determines the obese if the figure more than 30 kg/m2. There is an increased rate of overweight and obesity among pregnant women. According to the World Health Organization, 46% of adult females in Egypt are obese.
Many researches in the literature revealed a strong relationship between high BMI in pregnancy and iron deficiency anemia. Hepcidin is an iron regulating hormone in the body. Increases in iron levels in the plasma stimulate the production of hepcidin, which blocks iron absorption from the diet, so; hepcidin production is suppressed in the case of iron deficiency.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I: 27 mg elemental iron
Arm Type
Active Comparator
Arm Description
will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks
Arm Title
Group II: 54 mg elemental iron
Arm Type
Active Comparator
Arm Description
will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks
Intervention Type
Drug
Intervention Name(s)
Iron
Intervention Description
PharaFerro27; Devart Lab Company, Egypt
Intervention Type
Diagnostic Test
Intervention Name(s)
Complete blood count
Intervention Description
to assess the anemia
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum ferritin
Intervention Description
to assess the anemia
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum hepcidin
Intervention Description
to assess the iron abosrption
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum Iron
Intervention Description
to assess the anemia
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum total iron binding capacity
Intervention Description
to assess the anemia
Primary Outcome Measure Information:
Title
The number of anemic women at time of delivery
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The mean level of maternal Hemoglobin at 37-38 weeks .
Time Frame
6 months
Title
The incidence of patients' reported side effect
Time Frame
6 months
Title
The difference in serum ferritin
Time Frame
6 months
Title
The difference in serum hepcidin
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant woman in a singleton pregnancy (12-14 weeks).
BMI (30- 40 kg/m2).
Normal hemoglobin level (>11 g/dL).
Normal hematocrit (Hct 31-41%).
Normal ferritin level (6-130 ng/mL).
Women willingness to participate in the study.
Women living in the nearby area to make follow-up visits possible.
Exclusion Criteria:
Multiple gestations.
Women received a recent blood transfusion.
Women with threatened miscarriage.
Women are known to have pathological blood loss.
Intolerant to oral iron form.
History of the hematologic disorder.
Women used iron in the past 3 months.
Women with chronic diseases (hypertension, diabetes, renal diseases, thyroid disease……).
Facility Information:
Facility Name
Woman's Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant
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