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

Treatment of Iron Deficiency Anemia in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086838
• Other study ID #: 9020058
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2014
• Last updated: March 17, 2015
• Start date: July 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: AinShams University
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Treatment of Iron Deficiency Anemia in Pregnancy

Intervention

Drug:
• Theragran Hematinic

• low molecular weight iron dextran

Locations

Country	Name	City	State
Egypt	Maternity Hospital, Faculty of Madicine, AinShams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of participants with adverse effects		up to 8 weeks after completing treatment	Yes