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Completed

NCT Number: NCT02086838

Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy

Evaluate the effect of iron supplementation using oral routes in comparison with total dose infusion of low molecular weight iron dextran in iron deficiency anemia during pregnancy.

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Maternity Hospital, Faculty of Madicine, AinShams University

Cairo, Egypt

About this study

Patients will be allocated to two groups of 106 each and to insure that everyone has the chance of participation, randomization will be guided by table of random numbers All women recruited in the study will be given 100 mg mebendazole tablets twice daily for 3 days for de-worming and 500 micro gram folic acid daily till the end of the study The required dose will be individually adapted according to the total iron deficit which is dependent on the patient's body weight and hemoglobin status Total iron dose (mg) = weight (kg) X hemoglobin deficit {target hemoglobin (g/l)- Actual hemoglobin (g/l)} X 0.24 + 500 mg The total iron dose needed will be calculated by formula rounded to nearest multiple of 100 Group I includes pregnant women taking 60 mg elemental iron twice per day (120 mg/day) using iron tablets (Theragran Hematinic)® Smith-Kline Beecham, Egypt an affiliated co. to Glaxo Smith-Kline, according to the WHO guidelines for IDA control Group II includes pregnant women taking elemental iron in the form of low molecular weight dextran complex intravenously as a total dose infusion (T.D.I) using iron dextran ampules (Cosmofer)R Pharmacosmos Denmark (Inspire Pharma Egypt) Inclusion criteria

  • Maternal age 20-35 years old.
  • Singleton pregnancy between 16 - 24 weeks
  • Iron deficiency anemia with average hemoglobin ranging from 7-9 g/dL at the onset of the study

Exclusion criteris

  • Extremes of reproductive age (less than 20 years old or more than 35 years old).
  • Patients with multiple pregnancies.
  • Anemia not linked to iron deficiency.
  • Allergy to iron derivatives.
  • Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer.
  • Those who had received parenteral iron treatment earlier within 3 months before the start of the study.
  • Any obstetric complicating factors like pregnancy induced hypertension (PIH).
  • Patients with history of chronic blood loss.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Maternal age 20-35 years old.
  • Singleton pregnancy between 16 - 24 weeks.
  • Iron deficiency anemia with average hemoglobin ranging from 7-9 g % at the onset of the study.

Exclusion criteria

  • Extremes of reproductive age (less than 20 years old or more than 35 years old).
  • Patients with multiple pregnancies.
  • Anemia not linked to iron deficiency.
  • Allergy to iron derivatives.
  • Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer.
  • Those who had received parenteral iron treatment earlier within 3 months before the start of the study.
  • Any obstetric complicating factors like pregnancy induced hypertension.
  • Patients with history of chronic blood loss.

Treatment and study plan

Theragran Hematinic

Drug

Low Molecular Weight Iron Dextran

Drug

Other names: Cosmofer

Primary outcomes

  1. The proportion of patients who have been successfully treated

    Time frame: up to 8 weeks from comleting treatment

    The proportion of patients who have been successfully treated as evidenced by a hemoglobin concentration of > 10.5 g% after 8 weeks from completing treatment (oral or total iron dose infusion therapy).

Secondary outcomes

  1. Number of participants with adverse effects

    Time frame: up to 8 weeks after completing treatment

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Comparison Between Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 13, 2014
Registry last updated
Mar 19, 2015

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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