Heme-bound iron (Optifer) in treatment of pregnancy associated iron deficiency anemia

Not Applicable

Completed

• Conditions: Blood - Anaemia; Iron deficiency anemia with pregnancy

• Registration Number: ACTRN12618001482257
• Lead Sponsor: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.

Brief Summary

The hemoglobin and ferritin after Optifer treatment were significantly high compared to the ferrous fumarate treatment. The red blood cells corpuscular volume and red blood cells corpuscular hemoglobin were significantly high after Optifer compared to the ferrous fumarate treatment. The rates of poor compliance and gastrointestinal intolerance were significantly high in the ferrous fumarate treatment compared to Optifer treatment.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-04
• Study Completion: 2020-08-31
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 234

Inclusion Criteria

Inclusion criteria includes; pregnant women more than or equal 20 years old, 14-26 weeks` gestation, with hemoglobin less than or equal 10 gm/dl (8-10 gm/dl) due to iron deficincy anemia.
Iron deficiency anemia diagnosed by the following parameters; hemoglobin concentration (gm/dl), serum ferritin (ug/l), mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH).

Exclusion Criteria

Pregnant women with anemia other than iron deficiency anemia and/or received blood transfusion during current pregnancy will excluded from this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy of the heme-bound iron Optifer (HIO) compared to ferrous fumarate (Trihmeic) in treatment of pregnancy associated iron deficiency anemia. <br>Outcome assessed through laboratory tests including; complete blood picture and serum ferritin.<br><br>[3-4 months post-enrolment (final result) <br>while, the pregnant studied women with iron deficiency anemia will be checked in the ante-natal clinics every 2-4 weeks for monitoring of the treatment related side effects and complete blood picture monthly. ]

Secondary Outcome Measures

Name	Time	Method
The tolerability and the side effects (as gastrointestinal upset, metallic taste, constipation and/or intolerance ) related to the heme-bound iron Optifer and/or Trihmeic tablets using medications related side effects questionnaire designed specially for this study.[3-4 months post-enrolment (final result) <br>while, the pregnant studied women with iron deficiency anemia will be checked in the ante-natal clinics every 2-4 weeks for monitoring of the treatment related side effects and complete blood picture monthly. ]