Skip to main content
OpenTrials
Completed

NCT Number: NCT02590224

The Effect of Iron Deficiency Anemia During Pregnancy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton pregnancy.
  • Gestational age 14-18 weeks.
  • Mild to moderate anemia
  • No associated medical or obstetric complications.
  • Women not already receiving iron therapy.
  • Women accepted to participate in the study.

Exclusion criteria

  • Multiple pregnancy
  • Severe anemia
  • Iron hypersensitivity.
  • Liver diseases.
  • Women refuse to participate in the study.

Treatment and study plan

Ferrous bis-glycinate

Drug

Ferrous glycine sulphate

Drug

Primary outcomes

  1. the rate of increase of Hemoglobin level

    Time frame: 8 weeks

    difference in hemoglobin concentrations before and after treatment

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Ferrous Bis-glycinate Versus Ferrous Glycine Sulfate for the Treatment of Iron Deficiency Anemia During Pregnancy

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 28, 2015
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.