Status:
ENROLLING_BY_INVITATION
Iron and Immune Response to Vaccine (IRONMUM)
Lead Sponsor:
University of Oxford
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Iron deficiency causes anaemia and is common in pregnant women especially for those living in tropical regions where a high burden of infection and poor nutrition can compromise health. Low iron has b...
Detailed Description
This is a prospective interventional open label cohort study with an exploratory framework. After assessment of gestation by routine ultrasound, women will be invited to participate if they have a via...
Eligibility Criteria
Inclusion
- Viable singleton pregnancy\<28 weeks confirmed by ultrasound
- 18 years and older
- Willingness and ability to comply with the study protocol for the duration of the study
- Can understand information about the study and provide consent
Exclusion
- Any diphtheria-tetanus vaccine within the previous 2 years
- History of allergic reaction to diphtheria-tetanus or COVID-19 vaccine
- Haematocrit \<21% or Haematocrit \>50%
- Known severe haemoglobinopathy (HbE/beta-thalassaemia syndrome, beta-thalassaemia major or HbH syndrome)\* or G6PD deficiency
- \* Iron supplementation is safe in pregnant women with haemoglobin E, alpha-thalassemia 1, or beta-thalassemia carriers.
- HIV-positive
- Slide confirmed presence of malaria
- Fever (defined at \>37.5°C)
- Symptoms of COVID (these women will be PCR tested as routine in clinic)
- Known severe medical or obstetric complication e.g. valvular heart disease, placenta praevia
- Known or clinical vitB12 deficiency as indicated by megaloblastic anaemia (pernicious anaemia or clinical symptoms)
Key Trial Info
Start Date :
June 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05385042
Start Date
June 18 2022
End Date
December 31 2025
Last Update
August 19 2025
Active Locations (1)
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1
Shoklo Malaria Research Unit (SMRU)
Mae Sot, Changwat Tak, Thailand, 63110