Uganda Birth Cohort Study

NCT ID: NCT04233944

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

5044 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-15

Study Completion Date

2016-11-04

Brief Summary

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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

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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

Conditions

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Birth Outcomes Stunting Wasting Anemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant women and their infants

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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United States Agency for International Development (USAID)

FED

Sponsor Role collaborator

Makerere University

OTHER

Sponsor Role collaborator

Harvard University

OTHER

Sponsor Role collaborator

Tufts University

OTHER

Sponsor Role lead

Responsible Party

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Patrick Webb

Program Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick Webb, PhD

Role: STUDY_DIRECTOR

Tufts, Friedman School of Nutrition

Shibani Ghosh, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts, Friedman School of Nutrition

Locations

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Tufts University

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Mezzano J, Namirembe G, Ausman LM, Marino-Costello E, Shrestha R, Erhardt J, Webb P, Ghosh S. Effects of Iron and Vitamin A Levels on Pregnant Women and Birth Outcomes: Complex Relationships Untangled Using a Birth Cohort Study in Uganda. Matern Child Health J. 2022 Jul;26(7):1516-1528. doi: 10.1007/s10995-022-03387-5. Epub 2022 Mar 3.

Reference Type DERIVED
PMID: 35239084 (View on PubMed)

Madzorera I, Ghosh S, Wang M, Fawzi W, Isanaka S, Hertzmark E, Namirembe G, Bashaasha B, Agaba E, Turyashemererwa F, Webb P, Duggan C. Prenatal dietary diversity may influence underweight in infants in a Ugandan birth-cohort. Matern Child Nutr. 2021 Jul;17(3):e13127. doi: 10.1111/mcn.13127. Epub 2021 Feb 17.

Reference Type DERIVED
PMID: 33595899 (View on PubMed)

Other Identifiers

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11302

Identifier Type: -

Identifier Source: org_study_id

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