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

Not Applicable

Completed

• Conditions: Anemia of Pregnancy
• Interventions: Drug: Iron; Diagnostic Test: Complete blood count; Diagnostic Test: Serum ferritin; Diagnostic Test: Serum hepcidin; Diagnostic Test: Serum Iron; Diagnostic Test: Serum total iron binding capacity

• Registration Number: NCT04101461
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-22
• Study First Submitted QC: 2019-09-22
• Study First Posted: 2019-09-24
• Study Start: 2019-10-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 230

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......).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I: 27 mg elemental iron	Complete blood count	will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks
Group I: 27 mg elemental iron	Serum ferritin	will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks
Group I: 27 mg elemental iron	Serum hepcidin	will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks
Group I: 27 mg elemental iron	Serum Iron	will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks
Group I: 27 mg elemental iron	Serum total iron binding capacity	will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks
Group II: 54 mg elemental iron	Iron	will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks
Group II: 54 mg elemental iron	Complete blood count	will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks
Group II: 54 mg elemental iron	Serum ferritin	will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks
Group II: 54 mg elemental iron	Serum hepcidin	will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks
Group II: 54 mg elemental iron	Serum Iron	will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks
Group II: 54 mg elemental iron	Serum total iron binding capacity	will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks
Group I: 27 mg elemental iron	Iron	will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks

Primary Outcome Measures

Name	Time	Method
The number of anemic women at time of delivery	6 months

Secondary Outcome Measures

Name	Time	Method
The incidence of patients' reported side effect	6 months
The difference in serum ferritin	6 months
The difference in serum hepcidin	6 months
The mean level of maternal Hemoglobin at 37-38 weeks .	6 months

Trial Locations

Locations (1)

Woman's Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt