Micronutrient Supplementation for Pregnant Women in Uganda
Multiple Micronutrient Supplement (MMS) - dispensed in six 30-count bottles
+ Multiple Micronutrient Supplement (MMS) - dispensed in one 180-count bottle
+ Multiple Micronutrient Supplement (MMS) - dispensed in two 90-count bottles
Services Research Study
Summary
Study start date: June 18, 2025
Actual date on which the first participant was enrolled.This study is focused on understanding how giving pregnant women in Uganda a special vitamin supplement, called Multiple Micronutrient Supplementation (MMS), can be effectively integrated into their regular health care visits. It aims to find out how well this approach is accepted and how practical it is to implement in various regions. The research is significant because it examines whether providing different quantities of this supplement in bottles affects how often women attend their health check-ups and how regularly they take the supplements. By comparing different bottle sizes, the study hopes to improve health outcomes for pregnant women, ensuring they receive adequate nutrition during pregnancy. In this study, pregnant women visiting health centers in certain districts of Uganda will receive MMS tablets in one of three bottle sizes: a single bottle with 180 tablets, two bottles with 90 tablets each, or six bottles with 30 tablets each, distributed over time. The study will observe these women to see which bottle size encourages better adherence to taking the supplements and attending prenatal visits. This involves collecting data from various health facilities to understand the cost and impact of this intervention. The outcomes will help determine the best way to provide these supplements to improve maternal health in the region.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.4077 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Services Research Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria for Pregnant women- Enrolled for follow-up throughout pregnancy (sample 1) * ≤24 weeks of amenorrhea/gestation as verified by health professionals * Attending first ANC visit at government or PNFP health facilities. * Accepted to take MMS at first ANC visit Exclusion Criteria for Pregnant women- Enrolled for follow-up throughout pregnancy (sample 1) * Pregnant women with pre-existing hematological conditions such as sickle cell anemia, thalassemia, hemochromatosis. * Pregnant women planning to relocate outside the study district during the study period. Inclusion Criteria for Pregnant women / Women that have recently delivered (single contact) (sample 2) * Currently pregnant woman or a woman who is not more than 8 weeks postpartum. * Received MMS at an ANC visit at least 3 months ago or more. * Attended at least any 2 monthly ANC visits. * Attending/attended ANC at government or private-not-for-profit health facility. Exclusion Criteria for Pregnant women / Women that have recently delivered (single contact) (sample 2) * Enrolled in study population 1. * Women who are more than 8 weeks postpartum. Inclusion Criteria for ANC providers having ANC health education/counseling with pregnant woman(en) observed (sample 3) • Healthcare providers that are currently providing ANC health education (group) or ANC individual counseling at government or PNFP health facilities. Exclusion Criteria for ANC providers having ANC health education/counseling with pregnant woman(en) observed (sample 3) • Healthcare providers that are currently providing ANC health education (group) or ANC individual counseling to a woman(en) that have not provided written informed consent to have the ANC session observed. Inclusion Criteria for Influential family members (male partners \& mothers/mothers-in law) (sample 4) * Spouse or partner of a pregnant woman or woman with a child less than 8 weeks old who is receiving/ has received ANC services in one of the 8 study districts. * Mother or mother-in-law of a pregnant woman or woman with a child less than 8 weeks old who is receiving/ has received ANC services in one of the 8 study districts. Exclusion Criteria for Influential family members (male partners \& mothers/mothers-in law) (sample 4) • None Inclusion Criteria for Healthcare Providers- including facility in-charge, ANC providers, Health Assistants, staff in-charge of records, and stores manager (sample 5) * Health workers who provide ANC services (e.g., midwives/nurse, medical/ clinical officers, health assistants, and nutrition focal person) at government or private-not-for-profit facilities in one of the 8 study districts. * Health facility staff (e.g., Facility In-charge, Maternity In-charge, Pharmacy/Stores In-charge) at government or private-not-for-profit facilities in one of the 8 study districts. Exclusion Criteria for Healthcare Providers- including facility in-charge, ANC providers, Health Assistants, staff in-charge of records, and stores manager (sample 5) • None Inclusion Criteria for Community Health Workers (VHTs) and Mentor Mothers (sample 6) • Voluntary Health Team (VHT), Mentor Mothers, or Para-socials attached to at least one of the study facilities. Exclusion Criteria for Community Health Workers (VHTs) and Mentor Mothers (sample 6) • None Inclusion Criteria for National, regional, and district-level stakeholders (sample 7) * National, regional, or district-level decision-makers working in nutrition, maternal, newborn and child health, district health educator or pharmaceutical roles associated with the antenatal care system in Uganda. * Implementing partners involved in direct implementation of MMS within the 8 study districts Exclusion Criteria for National, regional, and district-level stakeholders (sample 7) • None Inclusion Criteria for Pregnant women - interviewed during post-intervention Household Coverage Survey (sample 8) * Woman who has been pregnant or delivered within the study period. * Household is within one of the 4 selected districts. Exclusion Criteria for Pregnant women - interviewed during post-intervention Household Coverage Survey (sample 8) • Women who moved to the district after delivery.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorGroup III
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location