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

Anemia of Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04101461
• Other study ID #: IDA-Obese
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: May 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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……).

Related Conditions & MeSH terms

• Anemia
• Anemia of Pregnancy
• Anemia, Iron-Deficiency

Intervention

Drug:
• Iron
PharaFerro27; Devart Lab Company, Egypt

Diagnostic Test:
• Complete blood count
to assess the anemia
• Serum ferritin
to assess the anemia
• Serum hepcidin
to assess the iron abosrption
• Serum Iron
to assess the anemia
• Serum total iron binding capacity
to assess the anemia

Locations

Country	Name	City	State
Egypt	Woman's Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of anemic women at time of delivery		6 months
Secondary	The mean level of maternal Hemoglobin at 37-38 weeks .		6 months
Secondary	The incidence of patients' reported side effect		6 months
Secondary	The difference in serum ferritin		6 months
Secondary	The difference in serum hepcidin		6 months