The use of iron administered as an infusion into a vein compared to the use of iron tablets taken by mouth for treating Nigerian women with iron deficiency anaemia during pregnancy

Phase 3

• Conditions: Haematological Disorders; Nutritional, Metabolic, Endocrine; Pregnancy and Childbirth; Maternal anaemia, preterm birth, maternal depression and low birth weight

• Registration Number: PACTR202012843695208
• Lead Sponsor: niversity of Lagos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: Female
• Target Recruitment: 1056

Inclusion Criteria

1. Pregnant women aged 15 to 49 years old.
2. Gestational age 20- and 32-weeks.
3. Baseline (enrollment) laboratory-confirmed moderate or severe anemia (Hb < 10g/dl).

Exclusion Criteria

1. Medically-confirmed significant bleeding, major surgery or received blood transfusion within the last 3 months
2. Symptomatic anemia with dyspnea or fatigue and a need for urgent correction
3. Concurrent anemia of another cause besides IDA.
4. Clinically-confirmed malabsorption syndrome or hypersensitivity to any form of iron treatment.
5. Preexisting maternal depression or other psychiatric illness
6. History of any immune related illness e.g., SLE, Rheumatoid arthritis.
7. Severe allergic reactions such as severe asthma.
8. Women with known drug allergies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The comparative effectiveness of treatment with intravenous ferric carboxymaltose (intervention) versus oral ferrous sulphate (control) in reducing the prevalence of maternal anemia at 36 weeks' gestation. 2. Reducing the incidence of preterm birth.

Secondary Outcome Measures

Name	Time	Method
1.Increase in maternal hemoglobin levels at 4 weeks post-initiation of treatment. <br>2.The safety and tolerability of intravenous ferric carboxymaltose versus oral ferrous sulphate, including the incidence of hypophosphatemia and severity of maternal adverse effects.<br>3.Severe maternal events, specifically, haemorrhage, sepsis, shock and the need for blood transfusion. <br>4.The incidence of low infant birthweight (<2.5 kg), prematurity (<37 weeks’ gestation as dated from the last menstrual period or a first trimester ultrasound scan), stillbirth and neonatal mortality (birth till 28 days of life), and proportion of infants being breastfed at 1, 2 and 4 weeks of life, and receiving BCG, oral polio and hepatitis vaccination in same time period.<br>5.The incidence of small for gestational age (birthweight less than the 10th percentile for gestational age).<br>6.Depression linked to emotional well-being of mothers using the validated Edinburgh Postnatal Depression Scale.<br>