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.
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.
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.
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.
Ecologic or community
Cross-sectional
Multiple micronutrient supplementation (MMS)
Dietary supplementEthiopia 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.
Iron folate supplementation (IFA)
Dietary supplementIFA delivered as part of routine antenatal care, according to current policy
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.
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London School of Hygiene and Tropical Medicine
Lead sponsor
Ethiopian Public Health Institute
Collaborator
