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The Effect of Iron Deficiency Anemia During Pregnancy

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EstadoTerminado
Patrocinadores
Assiut University

Palabras clave

Abstracto

Iron deficiency anemia during pregnancy is a significant worldwide health problem, affecting 22% of pregnant women in industrialized countries and 52% in non-industrialized countries. Iron deficiency anemia during pregnancy is associated with increased maternal as well as fetal morbidity, including prematurity, low birth-weight and perinatal and infant loss. Therefore, routine iron supplementation during the second half of pregnancy has been recommended once daily. Others, however, support a selective iron supplementation only for women with iron deficiency anemia, in order to avoid the increased risk of haemoconcentration associated with routine iron supplementation. Unfortunately, compliance to either iron-supplementation programs, especially among pregnant women, is poor, due in part to the side effects associated with these preparations.
Currently, there are many iron preparations available containing different types of iron salts, including ferrous sulfate, ferrous fumarate, ferrous ascorbate but common adverse drug reactions found with these preparations are mainly gastrointestinal intolerance like nausea, vomiting, constipation, diarrhea, abdominal pain, while ferrous bis-glycinate (fully reacted chelated amino acid form of iron) rarely make complication.
Product resulting from the reaction of a metal ion from a soluble salt with amino acids to form coordinate covalent bonds, the resulting molecule is called as chelate and chemical bonding process is called chelation. Ferrous bis-glycinate is highly stable and totally nutritionally functional chelate it is an amino acid fully reacted chelate which is formed by the binding of two molecules of glycine to one Fe2+ atom.

fechas

Verificado por última vez: 02/28/2018
Primero enviado: 10/26/2015
Inscripción estimada enviada: 10/26/2015
Publicado por primera vez: 10/27/2015
Última actualización enviada: 03/16/2018
Última actualización publicada: 03/19/2018
Fecha de inicio real del estudio: 12/31/2015
Fecha estimada de finalización primaria: 06/30/2017
Fecha estimada de finalización del estudio: 11/30/2017

Condición o enfermedad

Iron Deficiency Anemia

Intervención / tratamiento

Drug: Ferrous bis-glycinate group

Drug: Ferrous glycine sulphate group

Fase

Fase 4

Grupos de brazos

BrazoIntervención / tratamiento
Active Comparator: Ferrous bis-glycinate group
The patients will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets (Pharaferro 27 tablets) once daily for eight consecutive weeks.
Drug: Ferrous bis-glycinate group
Active Comparator: Ferrous glycine sulphate group
The patients will receive 567.6 mg of ferrous glycine sulphate capsules (Ferrosanol duodenale capsules, Schwarz) once daily for eight consecutive weeks.
Drug: Ferrous glycine sulphate group

Criterio de elegibilidad

Edades elegibles para estudiar 20 Years A 20 Years
Sexos elegibles para estudiarFemale
Acepta voluntarios saludablessi
Criterios

Inclusion Criteria:

1. Singleton pregnancy.

2. Gestational age 14-18 weeks.

3. Mild to moderate anemia

4. No associated medical or obstetric complications.

5. Women not already receiving iron therapy.

6. Women accepted to participate in the study.

Exclusion Criteria:

1. Multiple pregnancy

2. Severe anemia

3. Iron hypersensitivity.

4. Liver diseases.

5. Women refuse to participate in the study.

Salir

Medidas de resultado primarias

1. the rate of increase of Hemoglobin level [8 weeks]

difference in hemoglobin concentrations before and after treatment

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