NCT05708183 Healthy Mums, Healthy Babies: Multiple Micronutrient Supplementation in Ethiopia
| NCT ID | NCT05708183 |
| Status | Recruiting |
| Phase | — |
| Sponsor | London School of Hygiene and Tropical Medicine |
| Condition | Birth Weight |
| Study Type | OBSERVATIONAL |
| Enrollment | 25,620 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25,620 participants in total. It began in 2023-01-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 & Investigator
Tanya Marchant, PhD
PRINCIPAL INVESTIGATOR
London School of Hygiene and Tropical Medicine
Frequently Asked Questions
Who can join the NCT05708183 clinical trial?
This trial is open to female participants only, aged 15 Years or older, up to 49 Years, studying Birth Weight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05708183 currently recruiting?
Yes, NCT05708183 is actively recruiting participants. Contact the research team at tanya.marchant@lshtm.ac.uk for enrollment information.
Where is the NCT05708183 trial being conducted?
This trial is being conducted at Ītang, Ethiopia, Gīmbīcho, Ethiopia, Bona Gena, Ethiopia, Dara, Ethiopia and 2 additional locations.
Who is sponsoring the NCT05708183 clinical trial?
NCT05708183 is sponsored by London School of Hygiene and Tropical Medicine. The principal investigator is Tanya Marchant, PhD at London School of Hygiene and Tropical Medicine. The trial plans to enroll 25,620 participants.