Healthy Mums, Healthy Babies: Multiple Micronutrient Supplementation in Ethiopia
Healthy Mums, Healthy Babies in Ethiopia: a Cluster-randomized Trial to Evaluate the Programme Effectiveness of a Multiple Micronutrient Supplement Delivered to Pregnant Women Through Routine Antenatal Care to Improve Newborn Birthweight
1 other identifier
observational
25,620
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedFirst Posted
Study publicly available on registry
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedDecember 12, 2024
December 1, 2024
2 years
September 21, 2022
December 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Birthweight
The primary objective is to estimate the effect of MMS implementation on the mean birthweight of babies born in government health facilities to women living in areas where MMS is implemented, relative to the mean birthweight of babies born in government health facilities to women living in areas where standard antenatal IFA supplementation is implemented.
Birthweight from all live births occurring in enrolled facilities between Jan 23 - Dec 24
Study Arms (2)
Intervention
Districts that have substituted MMS for IFA as part of routine antenatal care
Comparison
Districts that continue to deliver IFA as part of routine antenatal care
Interventions
Ethiopia will distribute the UNIMMAP (United Nations International Multiple Micronutrient Antenatal Preparation) formulation that includes 30mg iron. The supplement contains 15 essential vitamins and minerals including: Retinol (Vitamin A-acetate) 800 μg; Vitamin E (as vitamin E-acetate) 10 mg; Vitamin D (as Cholecalciferol) 200 IU; Vitamin B1 (Thiamine mononitrate) 1.4 mg; Vitamin B2 (As Riboflavin) 1.4 mg; Vitamin B3 (As Nicotinamide) 18 mg; Vitamin B6 (as Pyridoxine 1.9 mg; Vitamin B12 (as Cyanocobalamin) 2.6 mg; Folic Acid 400 μg; Vitamin C (As Ascorbic Acid) 70 mg; Iron (As ferrous sulphate) 30 mg; Zinc (As zinc sulphate) 15 mg; Copper (as Copper Sulphate) 2 mg; Selenium (as Sodium selenite) 65 μg; Iodine (as Potassium Iodate) 150 μg.
IFA delivered as part of routine antenatal care, according to current policy
Eligibility Criteria
The study population for measurement of birth weight are mother and infant pairs: live newborns born to women who attend enrolled health facilities for childbirth care during the study period in the 42 study districts (clusters). Enrolled health facilities are all government health facilities providing childbirth services that, on average, manage at least 15 births per month (determined by the government database the "District Health Information System"). While acknowledging health-related exclusion criteria, all women attending health facilities for childbirth care in the intervention and comparison districts are potentially eligible for inclusion, irrespective of their place of usual residence or individual characteristics.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Gambella
Ītang, Gambella Region, Ethiopia
Oromia
Gīmbīcho, Oromiya, Ethiopia
Sidama
Bona Gena, Sidama Region, Ethiopia
SNNPR
Dara, Snnpr Region, Ethiopia
Somali
Āwarē, Somali, Ethiopia
Ethiopia Public Health Institute
Addis Ababa, Ethiopia
Related Publications (2)
Marchant T, Alemayehu S, Asfaw E, Daba AK, Defar A, Opondo C, Persson LA, Schellenberg J, Taye G, Tesfa A, Tessema B, Zenebe K, Tessema M. Effect of prenatal multiple micronutrient supplementation on birth weight in Ethiopia: protocol for a pragmatic cluster-randomised trial. BMJ Open. 2025 Feb 6;15(2):e093385. doi: 10.1136/bmjopen-2024-093385.
PMID: 39915025DERIVEDBerhanu AT, Defar A, Taye G, Daba AK, Alemayehu S, Tessema B, Zenebe K, Opondo C, Tollera G, Hailu M, Schellenberg J, Persson LA, Marchant T, Tessema M. Piloting Multiple Micronutrient Supplementation Within the Routine Antenatal Care System in Ethiopia: Insights From Stakeholders. Matern Child Nutr. 2025 Apr;21(2):e13809. doi: 10.1111/mcn.13809. Epub 2025 Jan 31.
PMID: 39887615DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tanya Marchant, PhD
London School of Hygiene and Tropical Medicine
- STUDY DIRECTOR
Masresha Tessema, PhD
Ethiopian Public Health Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2022
First Posted
February 1, 2023
Study Start
January 1, 2023
Primary Completion
December 31, 2024
Study Completion
August 31, 2025
Last Updated
December 12, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made open access one year after completion of the primary analysis.
- Access Criteria
- Full open access to this fully anonymised data.
Fully anonymised data will be made open access using the institutional repository. Open access IPD will have no identifiers beyond the study arm allocation and region. Data points included will be parity, use of antenatal care services, experience of service use, and birthweight (women) and provision of antenatal care services (health workers).