Actively Recruiting
Healthy Mums, Healthy Babies: Multiple Micronutrient Supplementation in Ethiopia
Led by London School of Hygiene and Tropical Medicine · Updated on 2024-12-12
25620
Participants Needed
6
Research Sites
139 weeks
Total Duration
On this page
Sponsors
L
London School of Hygiene and Tropical Medicine
Lead Sponsor
E
Ethiopian Public Health Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Background: This programme effectiveness study responds to the need for evidence on the effect on birthweight of switching from iron-folic acid supplementation (IFA) to multiple micronutrient supplementation (MMS) as part of routine antenatal care in Ethiopia. A 2019 meta-analysis of trial data reported a mean improvement of 35g in newborn birthweight amongst newborns born to women who took MMS in pregnancy compared to those who took IFA. Responding to this evidence, in 2020 the World Health Organisation updated its global guideline on MMS from 'not recommended' to 'recommended in the context of rigorous research'. The guideline identifies priority research being 'to establish the impact of switching routine antenatal IFA to MMS on important health outcomes, equity, acceptability, feasibility, sustainability and health-care resources in different country settings.' In 2022 the Ministry of Health of Ethiopia (MoH), will change from MMS to IFA in a set of pilot districts. EPHI and LSHTM have been asked to evaluate the effect of this change on mean birthweight and propose the current trial for this purpose. The overall aim is to evaluate the programme effectiveness on mean birthweight of providing MMS as part of routine antenatal care, compared to providing IFA. Findings will support the MoH to make evidence-informed decisions about the large-scale implementation of MMS in Ethiopia and also contribute to the global evidence base on the effectiveness of MMS in a programmatic setting. Methods: A two-arm cluster randomized trial will be used to estimate the effect of the programme change on mean birthweight, with cost-effectiveness and process evaluations embedded in the trial design. Women aged 15-49 who deliver a live born child in a study district health facility (mother/infant dyads) will be eligible for enrolment in the study. The primary outcome measure will be birthweight, recorded in facilities at the time of birth as part of the routine maternity care. Secondary objectives include costs of providing MMS, acceptability of MMS, adherence to antenatal micronutrient supplementation and implementation challenges.
CONDITIONS
Official Title
Healthy Mums, Healthy Babies: Multiple Micronutrient Supplementation in Ethiopia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mothers who deliver a liveborn child in enrolled health facilities and consent to participate
- Antenatal care staff and women attending routine antenatal care during survey periods
You will not qualify if you...
- Stillbirths are excluded from the primary outcome analysis
- Newborns who die while still in the facility are excluded from secondary analyses
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Gambella
Ītang, Gambella Region, Ethiopia
Actively Recruiting
2
Oromia
Gīmbīcho, Oromiya, Ethiopia
Actively Recruiting
3
Sidama
Bona Gena, Sidama Region, Ethiopia
Actively Recruiting
4
SNNPR
Dara, Snnpr Region, Ethiopia
Actively Recruiting
5
Somali
Āwarē, Somali, Ethiopia
Actively Recruiting
6
Ethiopia Public Health Institute
Addis Ababa, Ethiopia
Not Yet Recruiting
Research Team
T
Tanya Marchant, PhD
CONTACT
M
Masresha Tassema, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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