Clinical trial NCT02086838: Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy
Official title: Comparison Between Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Treatment of Iron Deficiency Anemia in Pregnancy
Keywords: Iron deficiency anemia
Pregnancy
Iron therapy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 212
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of patients who have been successfully treated
timeFrame: up to 8 weeks from comleting treatment
Secondary outcomes:
measure: Number of participants with adverse effects
timeFrame: up to 8 weeks after completing treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Maternity Hospital, Faculty of Madicine, AinShams University
Study officials:
affiliation: AinShams University
name: Mohamed S. Sweed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AinShams University
name: Hazem M. Sammour, Professor
role: STUDY_DIRECTOR
affiliation: AinShams University
name: Abdel-Latif G. El-Kholy, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: El Galaa Teaching Hospital
name: Eman M. El-Garhi, M.B.B.Ch.
role: PRINCIPAL_INVESTIGATOR
References: