Chelated Oral Iron Versus Intravenous Iron Sucrose for Treatment of Iron Deficiency Anemia Late in Pregnancy

NCT05151679 | Unknown

• 1 other identifier: oral iron versus I.V iron
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

compare the efficacy and safety of intravenous iron sucrose versus chelated oral iron in the treatment of iron deficiency anemia late in pregnancy.

Conditions

Iron Deficiency Anemia of Pregnancy

Interventions

Chelated Iron DRUG

Treatment will be started 24rh after initial visit women will be randomized used random sequence computer generated list in such a way that every patient had equal chance to be among any of the two groups either to group 1 , where they will receive I.V ferrous sucrose in the E.U in Women's Health Hospital Assuit University as an i.v infusion in 250 ml 0.9% sodium chloride slowly over 30 minutes. The total required dose of iron will be divided into three doses, which will be given every 3 days, and the maximum daily dose is 200mg ( 2 ampoules ).

Also known as: ferrotron

Iron sucrose DRUG

to group 2 where they will receive chelated oral iron, they will be given iron chelated amino acid containing 15 mg of elemental iron once daily for 6 weeks. the women will be advised to take 1 tab of iron chelated amino acid containing 15mg of elemental iron once daily with meals for 6 weeks from the day of recruitment.

Also known as: sacrofer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 years or more with established iron deficiency anemia ( Hb: 8-10 )
• Pregnancy 26-34 weeks

You may not qualify if:

• Anemia due to other causes than iron deficiency anemia.
• Recent blood transfusion (in the last 3 months ).
• Allergy to iron.
• Multiple pregnancy.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Bencaiova G, von Mandach U, Zimmermann R. Iron prophylaxis in pregnancy: intravenous route versus oral route. Eur J Obstet Gynecol Reprod Biol. 2009 Jun;144(2):135-9. doi: 10.1016/j.ejogrb.2009.03.006. Epub 2009 Apr 29.

  PMID: 19406557 RESULT

• Means RT. Iron Deficiency and Iron Deficiency Anemia: Implications and Impact in Pregnancy, Fetal Development, and Early Childhood Parameters. Nutrients. 2020 Feb 11;12(2):447. doi: 10.3390/nu12020447.

  PMID: 32053933 RESULT

MeSH Terms

Interventions

Iron Chelating Agents; Ferric Oxide, Saccharated

Intervention Hierarchy (Ancestors)

Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

mahmoud farghaly, resident

CONTACT

+201005450572; mahmoudshaban8.ms@gmail.com

mohammed sayed, prof

CONTACT

+201006801036; Msayed21@yahoo.com

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: November 28, 2021
• First Posted: December 9, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-11