A follow-up of the Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women (REVAMP) and their children: REVAMP Extend

Not Applicable

Completed

• Conditions: anaemia; iron deficiency; child development; Child growth; Maternal depression; Infection; Blood - Anaemia; Public Health - Other public health

• Registration Number: ACTRN12620000382976
• Lead Sponsor: niversity of Malawi, College of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-20
• Study Completion: 2022-08-12
• Last Update Posted: 16 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 862

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Child cognitive development measured using the Bayley Scales of Infant and Toddler Development-III (cognitive composite scores)[6 months of age]