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Uganda Birth Cohort Study

Terminated
Conditions
Birth Outcomes
Stunting
Wasting
Anemia
Registration Number
NCT04233944
Lead Sponsor
Tufts University
Brief Summary

The UBC was a USAID-funded longitudinal prospective cohort study of pregnant women (n= 5030) aged 15-49 years from rural North and South-Western regions of Uganda, conducted between 2014 and 2016. The aim of the UBC study was to observationally follow pregnant women and their newborns until 2 years of age and compare changes over time in communities that were part of an ongoing USAID project called the Community Connector (CC) compared to those communities that were not included in the Community Connector project.

Detailed Description

This study aimed to assess the role of livelihoods, agriculture and nutrition in improving maternal and child nutrition and health in rural Uganda in communities that were a part of an ongoing program that was un-related to the study. The overall aim of this study was to understand the effect of participating in an ongoing program that provided support on nutrition, agriculture, water, hygiene and sanitation and the change over time in the nutritional status of mothers and children under two years of age. The specific objectives of this observational study were as follows:

1. To compare health and nutrition status of pregnant women in communities participating in the Community Connector project to those that were not participating in the program

2. To assess the aflatoxin levels in pregnancy and test its association with birth outcomes and early life growth as measured by weight and length

3. To assess environmental enteropathy in pregnancy and test its association with birth outcomes and early life growth

4. To assess access to coverage and adherence to information/messages and engagement in Community Connector project's activities

5. To determine heterogeneity in program exposure and variability in household and agro-ecological characteristics and its relationship with maternal and infant health and nutrition status

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
5044
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percentage of infants with low birth weightBirth

Percentage of infants with birth weight less than 2500 grams

Percent of infants who were underweight0-2 years old

Percent of infants with a weight-for-age less than -2 standard deviations

Infants' weight at birth (kg)Birth

Birth weight in kilograms using a seca scale, calculated as the mean of three repeated measurements on each infant

Percentage of preterm birthsBirth

Percentage of infants born with a gestational age less than 259 days

Percentage of infants who were small-for-gestational-ageBirth

Percentage of infants at birth whose weight centiles were below the 10th percentile for their age and sex

Percent of infants who were stunted0-2 years old

Percent of infants with a height-for-age less than -2 standard deviations

Percent of infants who were wasted0-2 years old

Percent of infants with a weight-for-height less than -2 standard deviations

Head circumference measurement (cm)0-2 years old

Infant's head circumference measured in centimeters

Secondary Outcome Measures
NameTimeMethod
Percent of mothers that were anemic (hemoglobin levels <11 g/dL)through study completion, every 3 months

Percentage of maternal anemia defined by hemoglobin levels \<11 g/dL, measured using the HemoCue test.

Percent of infants that were anemic (hemoglobin levels <11 g/dL)0-2 years old

Percentage of infants with anemia defined by hemoglobin levels \<11 g/dL, measured using the HemoCue test.

Concentration of ferritin (ug/L) in mothers and infants as a biomarker for iron status6 months for infants, mothers at birth

Maternal and infants' serum ferritin (ug/L) measured using a sandwich enzyme-linked immunosorbent assay technique (ELISA) at the VitMin Lab in Germany

Concentration of soluble transferrin receptor (mg/L) in mothers and infants as a biomarker for iron status6 months for infants, mothers at birth

Maternal and infants' serum soluble transferrin receptor (mg/L) measured using a sandwich enzyme-linked immunosorbent assay technique (ELISA) at the VitMin Lab in Germany

Concentration of retinol binding protein (umol/L) in mothers and infants as a biomarker for vitamin A status6 months for infants, mothers at birth

Maternal and infants' serum retinol binding protein (umol/L) measured using a sandwich enzyme-linked immunosorbent assay technique (ELISA) at the VitMin Lab in Germany

Trial Locations

Locations (1)

Tufts University

🇺🇸

Boston, Massachusetts, United States

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