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

Assiut University

Status: Completed

Conditions: Anemia of Pregnancy

Treatments: Diagnostic Test: Serum hepcidin; Diagnostic Test: Serum Iron; Diagnostic Test: Serum ferritin; Drug: Iron; Diagnostic Test: Serum total iron binding capacity; Diagnostic Test: Complete blood count

Study type: Interventional

Funder types: Other

Identifiers

NCT04101461

IDA-Obese

Details and patient eligibility

About

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.

Enrollment: 230 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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......).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Group I: 27 mg elemental iron

Active Comparator group

Description:

will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks

Treatment:

Diagnostic Test: Serum hepcidin

Diagnostic Test: Serum Iron

Diagnostic Test: Serum total iron binding capacity

Diagnostic Test: Serum ferritin

Diagnostic Test: Complete blood count

Drug: Iron

Group II: 54 mg elemental iron

Active Comparator group

Description:

will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks

Treatment:

Diagnostic Test: Serum hepcidin

Diagnostic Test: Serum Iron

Diagnostic Test: Serum total iron binding capacity

Diagnostic Test: Serum ferritin

Diagnostic Test: Complete blood count

Drug: Iron