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

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.

Study Overview

• Status: Completed
• Conditions: Anemia of Pregnancy
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Woman's Health Hospital - Assiut university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I: 27 mg elemental iron; will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks	Drug: Iron; PharaFerro27; Devart Lab Company, Egypt; Diagnostic test: Complete blood count; to assess the anemia; Diagnostic test: Serum ferritin; to assess the anemia; Diagnostic test: Serum hepcidin; to assess the iron abosrption; Diagnostic test: Serum Iron; to assess the anemia; Diagnostic test: Serum total iron binding capacity; to assess the anemia
Active Comparator: Group II: 54 mg elemental iron; will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks	Drug: Iron; PharaFerro27; Devart Lab Company, Egypt; Diagnostic test: Complete blood count; to assess the anemia; Diagnostic test: Serum ferritin; to assess the anemia; Diagnostic test: Serum hepcidin; to assess the iron abosrption; Diagnostic test: Serum Iron; to assess the anemia; Diagnostic test: Serum total iron binding capacity; to assess the anemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of anemic women at time of delivery	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: September 22, 2019
• First Submitted That Met QC Criteria: September 22, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Physiological Effects of Drugs; Anti-Infective Agents; Trace Elements; Micronutrients; Iron; Hepcidins
• Other Study ID Numbers: IDA-Obese

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No