Evaluating the impact of multiple micronutrient supplementation on birth weight 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
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 type | Observational |
|---|---|
| Enrollment | 25620 (estimated) |
| Ages | 15 Years to 49 Years |
| Sex | Female |
| Sponsor | London School of Hygiene and Tropical Medicine Academic / other |
| Locations | 6 sites (Ītang, Gambella Region and 5 other locations) |
| Trial ID | NCT05708183 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who experience stillbirths or those who do not deliver in the enrolled health facilities may not benefit from this study.
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 performed: Previous studies have shown positive outcomes with multiple micronutrient supplementation, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Ītang, Gambella Region and 5 other locations
- 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
- Principal investigator: Tanya Marchant, PhD — London School of Hygiene and Tropical Medicine
- Study coordinator: Tanya Marchant, PhD
- Email: tanya.marchant@lshtm.ac.uk
- Phone: +44 (0)7713088730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.