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

NCT02086838 | Completed Phase 4

• 1 other identifier: 9020058
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment of Iron Deficiency Anemia in Pregnancy

Keywords

Iron deficiency anemia; Pregnancy; Iron therapy

Outcome Measures

Primary Outcomes (1)

• The proportion of patients who have been successfully treated

  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).

  up to 8 weeks from comleting treatment

Secondary Outcomes (1)

• Number of participants with adverse effects

  up to 8 weeks after completing treatment

Study Arms (2)

Theragran Hematinic, oral iron, 120 mg elemental iron/

ACTIVE COMPARATOR

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

low molecular weight iron dextran, total dose infusion

ACTIVE COMPARATOR

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

Interventions

Theragran Hematinic DRUG

Theragran Hematinic, oral iron, 120 mg elemental iron/

low molecular weight iron dextran DRUG

Also known as: Cosmofer

low molecular weight iron dextran, total dose infusion

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Maternity Hospital, Faculty of Madicine, AinShams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mohamed S. Sweed, MD

  AinShams University

  PRINCIPAL INVESTIGATOR

• Hazem M. Sammour, Professor

  AinShams University

  STUDY DIRECTOR

• Abdel-Latif G. El-Kholy, Ass. Prof.

  AinShams University

  PRINCIPAL INVESTIGATOR

• Eman M. El-Garhi, M.B.B.Ch.

  El Galaa Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 13, 2014
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 19, 2015

Record last verified: 2015-03

Locations

EG (1)