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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT02086838

Collaborator

(none)

212

Enrollment

Location

Arms

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Treatment of Iron Deficiency Anemia in Pregnancy	Drug: Theragran Hematinic Drug: low molecular weight iron dextran	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

212 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Theragran Hematinic, oral iron, 120 mg elemental iron/ 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.	Drug: Theragran Hematinic
Active Comparator: low molecular weight iron dextran, total dose infusion 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.	Drug: low molecular weight iron dextran Other Names: Cosmofer

Arm

Intervention/Treatment

Active Comparator: Theragran Hematinic, oral iron, 120 mg elemental iron/

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.

Drug: Theragran Hematinic

Active Comparator: low molecular weight iron dextran, total dose infusion

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.

Drug: low molecular weight iron dextran

Other Names:

Cosmofer

Outcome Measures

Primary Outcome Measures

The proportion of patients who have been successfully treated [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 Outcome Measures

Number of participants with adverse effects [up to 8 weeks after completing treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maternity Hospital, Faculty of Madicine, AinShams University	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Mohamed S. Sweed, MD, AinShams University
Study Director: Hazem M. Sammour, Professor, AinShams University
Principal Investigator: Abdel-Latif G. El-Kholy, Ass. Prof., AinShams University
Principal Investigator: Eman M. El-Garhi, M.B.B.Ch., El Galaa Teaching Hospital