Uganda Birth Cohort Study

NCT04233944 | Terminated

• 1 other identifier: 11302
• Study Type: observational
• Target: 5,044
• Locations: 1 country
• Sites: 1

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.

Conditions

Birth Outcomes; Stunting; Wasting; Anemia

Keywords

Birth Outcomes; Pregnancy; Aflatoxin; Environmental Enteric Dysfunction (EED); Growth; Stunting; Wasting; Uganda; Anemia

Outcome Measures

Primary Outcomes (8)

• Percent of infants who were stunted

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

  0-2 years old

• Percent of infants who were wasted

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

  0-2 years old

• Percent of infants who were underweight

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

  0-2 years old

• Infants' weight at birth (kg)

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

  Birth

• Percentage of infants with low birth weight

  Percentage of infants with birth weight less than 2500 grams

  Birth

• Percentage of preterm births

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

  Birth

• Percentage of infants who were small-for-gestational-age

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

  Birth

• Head circumference measurement (cm)

  Infant's head circumference measured in centimeters

  0-2 years old

Secondary Outcomes (5)

• Percent of mothers that were anemic (hemoglobin levels <11 g/dL)

  through study completion, every 3 months

• Percent of infants that were anemic (hemoglobin levels <11 g/dL)

  0-2 years old

• Concentration of ferritin (ug/L) in mothers and infants as a biomarker for iron status

  6 months for infants, mothers at birth

• Concentration of soluble transferrin receptor (mg/L) in mothers and infants as a biomarker for iron status

  6 months for infants, mothers at birth

• Concentration of retinol binding protein (umol/L) in mothers and infants as a biomarker for vitamin A status

  6 months for infants, mothers at birth

Study Arms (1)

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.

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women, children under two years, and their households in Northern and Southwestern Uganda during 2014-2016

You may qualify if:

• 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
• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• Tufts University: lead
• United States Agency for International Development (USAID): collaborator
• Makerere University: collaborator
• Harvard University: collaborator

Study Sites (1)

Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Publications (2)

• 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.

  PMID: 35239084 DERIVED

• 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.

  PMID: 33595899 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Growth Disorders; Cachexia; Anemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Thinness; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Patrick Webb, PhD

  Tufts, Friedman School of Nutrition

  STUDY DIRECTOR

• Shibani Ghosh, PhD

  Tufts, Friedman School of Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director

Study Record Dates

• First Submitted: January 11, 2020
• First Posted: January 18, 2020
• Study Start: November 15, 2014
• Primary Completion: November 4, 2016
• Study Completion: November 4, 2016
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: End of 2020
• Access Criteria: Data will be publicly accessible

Locations

US (1)