Healthy Mums, Healthy Babies: Multiple Micronutrient Supplementation in Ethiopia

Recruiting now

Conditions studied: Birth Weight

In brief

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.

Key facts

Study ID

NCT05708183

Run by

London School of Hygiene and Tropical Medicine

People needed

25620

Starts

2023-01-01

Expected to finish

2025-08-31

Last updated by the study team

2024-12-12

Who can join

Age: 15 and older, up to 49. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• For the primary outcome, mothers who deliver a liveborn child in enrolled health facilities and who are willing/consent to participate in the study.
• For the secondary objectives, all antenatal care staff and women attending for routine antenatal care during the survey periods will be included.

You may not qualify if…

• For the primary outcome, stillbirths will be excluded. Data for any newborn who subsequently dies while still in the facility will be excluded from all secondary analyses.

Where it is running

• Gambella — Ītang, Gambella Region, Ethiopia (enrolling)
• Oromia — Gīmbīcho, Oromiya, Ethiopia (enrolling)
• Sidama — Bona Gena, Sidama Region, Ethiopia (enrolling)
• SNNPR — Dara, Snnpr Region, Ethiopia (enrolling)
• Somali — Āwarē, Somali, Ethiopia (enrolling)
• Ethiopia Public Health Institute — Addis Ababa, Ethiopia

Full record on ClinicalTrials.gov

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