Status:

COMPLETED

Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

Lead Sponsor:

Ain Shams University

Conditions:

Iron Deficiency Anemia

Eligibility:

FEMALE

18-38 years

Phase:

PHASE2

Brief Summary

The main drawbacks with oral iron are side-effects, poor compliance, and limited absorption from the gut. It has become very apparent gastrointestinal intolerance with oral iron therapy is dose relate...

Eligibility Criteria

Inclusion

  • Pregnant women with single fetus.
  • Second trimester (14-20weeks of gestation).
  • Normal Hemoglobin level: more than10g\\dl.
  • Serum ferritin less than 15 mcg / L

Exclusion

  • Other type than iron-deficiency anemia (thalassemia, hemolytic anemia … etc.)
  • Any other chronic diseases (bronchial asthma, renal or hepatic, hematological or cardiovascular diseases … etc.)
  • Having hypersensitivity to iron preparations.
  • Treatment with any other iron preparation in the last month.
  • History of peptic ulcer, oesophagitis or hiatal hernia.
  • Medical disorders with pregnancy.
  • Need for alternative parenteral route to blood transfusion when rapid increase is required (perioperative anemia-severe anemia in late pregnancy-postpartum anemia) .
  • Bleeding in early pregnancy.
  • Refusal to participate in the study.
  • Family history of thalassemia-sickle cell anemia or malabsorption syndrome.
  • Recent blood transfusion.
  • Inflammatory bowel disease as intolerance of oral therapy but tolerated to parenteral route.

Key Trial Info

Start Date :

January 15 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 20 2018

Estimated Enrollment :

98 Patients enrolled

Trial Details

Trial ID

NCT03759353

Start Date

January 15 2018

End Date

November 20 2018

Last Update

November 30 2018

Active Locations (1)

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1

Ain SHams Maternity Hospital

Cairo, Abbaseya, Egypt, 002