Uganda Birth Cohort Study (UBC)

Tufts University

Status: Terminated

Conditions: Anemia; Birth Outcomes; Wasting; Stunting

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04233944

11302 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 5,044 patients

Sex: Female

Ages: 15 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion into pregnancy surveillance:

• Participant is a woman aged 15-49 years
• Participant intends to reside in the study area through the enrollment period
• Participant provides informed consent herself or through a legal guardian

Inclusion into main study:

• Pregnancy is confirmed by urine pregnancy test
• Mother is aged 15-49 years
• Mother intends to reside in the study area through completion of follow-up
• Mother intends to deliver in the study area
• Mother provides informed consent (potentially as an emancipated minor)

Exclusion criteria

-None

Trial design

5,044 participants in 1 patient group

Pregnant women and their infants

Description:

Mothers and their infants were followed throughout the first two years of the infant's life. Data were collected at enrollment, birth, 3, 6, 9,12, 18 and 24 months from the date of delivery.