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The Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant

The Effectiveness of Single Versus Double Daily Dose of Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04101461
Enrollment
230
Registered
2019-09-24
Start date
2019-10-01
Completion date
2022-04-01
Last updated
2022-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia of Pregnancy

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.

Interventions

DRUGIron

PharaFerro27; Devart Lab Company, Egypt

DIAGNOSTIC_TESTComplete blood count

to assess the anemia

DIAGNOSTIC_TESTSerum ferritin

to assess the anemia

DIAGNOSTIC_TESTSerum hepcidin

to assess the iron abosrption

DIAGNOSTIC_TESTSerum Iron

to assess the anemia

DIAGNOSTIC_TESTSerum total iron binding capacity

to assess the anemia

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

1. Pregnant woman in a singleton pregnancy (12-14 weeks). 2. BMI (30- 40 kg/m2). 3. Normal hemoglobin level (\>11 g/dL). 4. Normal hematocrit (Hct 31-41%). 5. Normal ferritin level (6-130 ng/mL). 6. Women willingness to participate in the study. 7. Women living in the nearby area to make follow-up visits possible.

Exclusion criteria

1. Multiple gestations. 2. Women received a recent blood transfusion. 3. Women with threatened miscarriage. 4. Women are known to have pathological blood loss. 5. Intolerant to oral iron form. 6. History of the hematologic disorder. 7. Women used iron in the past 3 months. 8. Women with chronic diseases (hypertension, diabetes, renal diseases, thyroid disease……).

Design outcomes

Primary

MeasureTime frame
The number of anemic women at time of delivery6 months

Secondary

MeasureTime frame
The mean level of maternal Hemoglobin at 37-38 weeks .6 months
The incidence of patients' reported side effect6 months
The difference in serum ferritin6 months
The difference in serum hepcidin6 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026