None listed
Conditions
Brief summary
Antenatal anaemia is associated with critical risks for both mother and child. A new intravenous iron formulation, ferric carboxymaltose, now available in developed countries, provides the opportunity to give high doses of iron (up to 15mg/kg or 1000mg) in a single rapid infusion. Intravenous iron could present a novel, innovative opportunity to rapidly cure moderate and severe antenatal anaemia, thereby improving crucial maternal and child outcomes. We are undertaking a randomised controlled trial to assess effects of IV iron compared with oral iron for antenatal anaemia in Malawi, on maternal and newborn health. We will now extend the cohort of women and babies post-partum to assess the longer term benefits and safety of this approach.
Interventions
This is a follow-up study of REVAMP (ACTRN12618001268235), in which pregnant women with Hb<10g/dL randomly assigned to the intervention group received the following:
Intravenous iron treatment: intravenous ferric carboxymaltose 1000mg (weight >50kg) or 20mg/kg (weight <50kg) given over 15min once at recruitment (Day 0).
Participants will comprise mothers enrolled in the trials and their babies. They will undergo ongoing observational follow up comprising questionnaires, physical assessment, cogn
This is a follow-up study of REVAMP (ACTRN12618001268235), in which pregnant women with Hb<10g/dL randomly assigned to the intervention group received the following: Intravenous iron treatment: intravenous ferric carboxymaltose 1000mg (weight >50kg) or 20mg/kg (weight <50kg) given over 15min once at recruitment (Day 0). Participants will comprise mothers enrolled in the trials and their babies. They will undergo ongoing observational follow up comprising questionnaires, physical assessment, cognitive assessments, and laboratory sample assessment (blood and/or stool) at 3, 6, 9 and 12 months post birth/ partum. EEG neurocognitive assessments in children at 6 months will be undertaken. Children will be assessed for the presence of radiological rickets at 6 and 12 months of age. We will take x-rays of wrist and knee to identify the presence of radiological rickets using standard techniques. A study radiologist will assess the x-rays and the data will be collected into the trial's REDCAP database. The use of x-rays is a safe and non-invasive method for the assessment of bones. Neurodevelopment will be assessed in children using portable low field magnetic resonance imaging technology (Hyperfine) as 12 months of age. After provision of detailed information and the opportunity to ask questions, mothers will be invited to provide written informed consent for their participation and the participation of their infant in the REVAMP-Bone and -Neuro sub-study. The first 200 mothers who provide informed consent for themselves and their infants will continue with the study visits. REVAMP-Extend participants will be invited to participate
Sponsors
University of Malawi, College of Medicine
Eligibility
Sex/Gender
All
Age
3 Months to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must have participated in the main REVAMP trial, or be a child born to a participant of the parent study to be included in this substudy. Participants meeting the following criteria were included in the parent trial (main REVAMP trial): 1. Confirmed singleton pregnancy at 13-26 weeks gestation 2. Moderate to severe anaemia not requiring an immediate blood transfusion (Hb <10g/dl) 3. Negative malaria parasitaemia 4. Resident in the study catchment area of Blantyre and Zomba district 5. Plan to deliver at a health facility 6. Written informed consent (including assent if <18 years old)
Exclusion criteria
Non participation in the main REVAMP trial.
Outcome results
None listed