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Iron Deficiency Anemia of Pregnancy | Treatment of Iron Deficiency Anemia With Pregnancy

Iron Deficiency Anemia of Pregnancy research study

What is the primary objective of this study?

Iron deficiency anemia is a very common problem accompanying pregnancy. in this study, the investigators are going to compare the efficacy and tolerability of two preparations of oral iron in treatment of iron deficiency anemia with pregnancy.

Who is eligible to participate?

Inclusion Criteria: - Age: 20-40 years - Pregnant 14-18 weeks - Singleton fetus - Hb 7-10.9 g/dl - Serum ferritin <12 microgram/L Exclusion Criteria: - history of anemia due to other causes as chronic blood loss, hemolytic anemia or thalassemia - Multiple pregnancy - known hepatic, renal or cardiovascular abnormality. - Known peptic ulcer, esophagitis, gastritis or hiatus hernia. - Family history of thalassemia, sickle cell anemia, or malabsorption syndrome. - Iron preparation intake within 24 hours of inclusion

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Iron Deficiency Anemia of Pregnancy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:amino acid chelated ironthe drug will be given to pregnant women 14-18 weeks' gestation who prove to have iron deficiency anemia. the dose will be given according to hemoglobin level. for hemoglobin 7-9 g/dl, 2 capsules will be given daily. for hemoglobin 9.1-11 g/dl, 1 capsule will be given daily. complete blood picture and serum ferritin will be measured at 22-23, 29-30 and 36-37 weeks' gestation.

Drug:iron salt (ferrous fumarate)this drug will be given to pregnant women 14-18 weeks' gestation with iron deficiency anemia. the dose will be given according to hemoglobin level. for hemoglobin 7-9 g/dl, 2 capsules will be given daily, and for hemoglobin 9.1-11 g/dl, 1 capsule will be given daily. complete blood picture and serum ferritin will be measured at 22-23, 29-30 and 36-37 weeks' gestation.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

amino acid chelated iron armthis arm will contain 150 pregnant women with proved iron deficiency anemia and pregnant 14-18 weeks. these pregnant women will be given amino acid chelated iron capsules (15 mg iron/capsule) 1-2 capsules daily according to hemoglobin level (hemoglobin 7-9 g/dl will receive 2 capsules, and hemoglobin 9.1-11 g/dl will receive 1 capsule). complete blood picture and serum ferritin will be assessed at 22-23 weeks, 29-30 weeks and 36-37 weeks. possible side effects (colicky abdominal pains, constipation and metallic taste) will be asked about in each follow up visit.

iron salt armthis arm will contain 150 pregnant women with proved iron deficiency anemia and 14-18 weeks gestation. these women will be given oral iron salt ferrous fumarate capsules (350 mg iron/ capsule containing about 70 mg elemental iron/ capsule) 1-2 capsules daily according to hemoglobin level (hemoglobin 7-9 g/dl will receive 2 capsules daily and hemoglobin 9.1-11 g/dl will receive 1 capsule daily. women will be followed up with complete blood picture and serum ferritin at 22-23 weeks, 29-30 weeks and 36-37 weeks. women will be asked about possible side effects (colicky abdominal pains, constipation, and metallic taste) in each visit.

Study Status

Completed

Start Date: December 2013

Completed Date: July 2015

Phase: Early Phase 1

Type: Interventional

Design:

Primary Outcome: change in hemoglobin level

Secondary Outcome: the occurence of side effects (abdominal colics, constipation, or metallic taste)

Study sponsors, principal investigator, and references

Principal Investigator: Ahmed M Sayed, professor

Lead Sponsor: Cairo University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02005588

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