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Completed

NCT Number: NCT04101461

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

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.

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Key information

Conditions

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Woman's Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Iron

Drug

PharaFerro27; Devart Lab Company, Egypt

Complete blood count

Diagnostic Test

to assess the anemia

serum ferritin

Diagnostic Test

to assess the anemia

Serum hepcidin

Diagnostic Test

to assess the iron abosrption

Serum Iron

Diagnostic Test

to assess the anemia

Serum total iron binding capacity

Diagnostic Test

to assess the anemia

Primary outcomes

  1. The number of anemic women at time of delivery

    Time frame: 6 months

Secondary outcomes

  1. The mean level of maternal Hemoglobin at 37-38 weeks .

    Time frame: 6 months

  2. The incidence of patients' reported side effect

    Time frame: 6 months

  3. The difference in serum ferritin

    Time frame: 6 months

  4. The difference in serum hepcidin

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2019
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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