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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Treatment of Iron Deficiency Anemia in Pregnancy

Treatments: Drug: low molecular weight iron dextran; Drug: Theragran Hematinic

Study type: Interventional

Funder types: Other

Identifiers

NCT02086838

9020058

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 212 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups

Theragran Hematinic, oral iron, 120 mg elemental iron/

Active Comparator group

Description:

pregnant women taking 60 mg elemental iron twice per day (120 mg/day) using iron tablets (Theragran Hematinic)® SmithKline Beecham, Egypt an affiliated co. to GlaxoSmithKline. Adherence to the treatment will be monitored by asking the women to bring back the empty packs and mark the consumption of tablets on calendar.

Treatment:

Drug: Theragran Hematinic

low molecular weight iron dextran, total dose infusion

Active Comparator group

Description:

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). Patients selected for parental iron will be admitted as day cases in the hospital in a single visit. The required dose has to 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.

Treatment:

Drug: low molecular weight iron dextran