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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03009578
Other study ID # OFB-IDA
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 1, 2017
Est. completion date June 5, 2018

Study information

Verified date June 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Iron deficiency may result from inadequate dietary intake, achlorhydria or excessive ingestion of proton pump inhibitors, parasitic infestations, chronic infections and repeated pregnancies. Iron supplementation of antenatal patients is a basic tenet of antenatal care programmes in numerous developing and underdeveloped nations.

Postpartum anemia is defined as hemoglobin of less than 11.5 gm% during the postpartum period. The prevalence of postpartum anemia varies from 4 - 27%. Chronic iron deficiency due to inadequate intake/ lack of iron supplementation during pregnancy, repeated pregnancies and postpartum hemorrhage are important causes of postpartum anemia


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 5, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

Hemoglobin level 7-11.5 gm/dl. No chronic diseases. Breastfeeding. Delivered at gestational age >38 weeks. Within 24-72 hours postpartum. Women who accept to participate in the study

Exclusion Criteria:

1. Severe anemia < 7 gm/dl.

2. Women received iron therapy during pregnancy.

3. Intolerance to iron preparations

4. Anemia due to other causes

5. Peripartum blood transfusion.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Iron Sucrose Injection
iron Intramuscular injections
Ferrous Bisglycinate
oral iron tablets

Locations

Country Name City State
Egypt Assiut Faculty of Medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary the percentage of patients achieving Hb rise 3 gm or more 6 weeks
Secondary Mean rise of Hb from baseline to 6 weeks. 6 weeks
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