Clinical trial Recruiting at 5 sites Observational Ages 15 to 49 Women only

Evaluating the impact of multiple micronutrient supplementation on birth weight in Ethiopia

Official title: 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

Run by London School of Hygiene and Tropical Medicine · NCT05708183 · Data updated 2026-11-12

This study is testing whether giving pregnant women multiple vitamins instead of just iron and folic acid can help improve the birth weight of their babies in Ethiopia.

Quick facts

Study typeObservational
Ages15 Years to 49 Years
SexWomen only
Enrollment25620 (estimated)
SponsorLondon School of Hygiene and Tropical Medicine
Academic / other
Locations6 sites (Ītang, Gambella Region and 5 other locations)
StatusRecruiting
StartedJanuary 1, 2023
Main results expectedDecember 31, 2024
Study endsAugust 31, 2025
Registry record updatedDecember 12, 2024
Trial IDNCT05708183 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are pregnant women who are receiving antenatal care in the specified health facilities and are willing to participate.

Probably not a fit

Patients who experience stillbirths or those who do not deliver in the enrolled health facilities may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This program effectiveness study aims to assess the impact of switching from iron-folic acid supplementation to multiple micronutrient supplementation during routine antenatal care in Ethiopia. The study involves a cluster randomized trial where districts are assigned to either continue with iron-folic acid or switch to multiple micronutrient supplementation. The primary outcome measured will be the birth weight of newborns, with additional evaluations on cost and process effectiveness. The study will run for 42 months, collecting data on birth weights and other relevant health outcomes.

Why it matters

Potential benefit: If successful, this study could lead to improved birth weights and better health outcomes for newborns in Ethiopia.

How similar studies have gone: Previous studies have shown positive outcomes with multiple micronutrient supplementation, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Gambella
    Ītang, Gambella Region, Ethiopia
    Recruiting
  • Oromia
    Gīmbīcho, Oromiya, Ethiopia
    Recruiting
  • Sidama
    Bona Gena, Sidama Region, Ethiopia
    Recruiting
  • Snnpr
    Dara, Snnpr Region, Ethiopia
    Recruiting
  • Somali
    Āwarē, Somali, Ethiopia
    Recruiting
  • Ethiopia Public Health Institute
    Addis Ababa, Ethiopia
    Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.