Suplementación con micronutrientes para mujeres embarazadas en 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
Estudio de Investigación en servicios de salud
Resumen
Fecha de inicio: 18 de junio de 2025
Fecha en la que se inscribió al primer participante.Este estudio se centra en comprender cómo se puede integrar de manera efectiva la administración de un suplemento vitamínico especial, llamado Suplementación Múltiple de Micronutrientes (MMS), a las mujeres embarazadas en Uganda durante sus visitas regulares de atención médica. Busca determinar qué tan bien es aceptado este enfoque y qué tan práctico es implementarlo en diversas regiones. La investigación es significativa porque examina si proporcionar diferentes cantidades de este suplemento en frascos afecta la frecuencia con la que las mujeres asisten a sus chequeos de salud y la regularidad con la que toman los suplementos. Al comparar diferentes tamaños de frascos, el estudio espera mejorar los resultados de salud para las mujeres embarazadas, asegurando que reciban una nutrición adecuada durante el embarazo. En este estudio, las mujeres embarazadas que visitan centros de salud en ciertos distritos de Uganda recibirán tabletas de MMS en uno de tres tamaños de frascos: un solo frasco con 180 tabletas, dos frascos con 90 tabletas cada uno, o seis frascos con 30 tabletas cada uno, distribuidos con el tiempo. El estudio observará a estas mujeres para ver qué tamaño de frasco fomenta una mejor adherencia a la toma de los suplementos y a las visitas prenatales. Esto implica recopilar datos de diversas instalaciones de salud para comprender el costo y el impacto de esta intervención. Los resultados ayudarán a determinar la mejor manera de proporcionar estos suplementos para mejorar la salud materna en la región.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 4077 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Investigación en Servicios de Salud
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Hasta 80 Años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
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.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.3 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
Comparador ActivoGrupo III
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación