Maternal EED and Aflatoxin Birth Outcomes Study Uganda

NCT03429257 | Completed

• 1 other identifier: AID-OAA-L-10-00006
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective cohort study focuses on the relationship between maternal environmental enteric dysfunction (EED) and maternal aflatoxin B1 exposure and birth outcomes, particularly infant anthropometry and gestational age, in Mukono, Uganda.

Conditions

Birth Weight; Pregnancy Preterm; Aflatoxins Toxicity; Inflammatory Response

Keywords

Aflatoxin B1; Environmental Enteric Dysfunction; L:M Test; Pregnancy; Linear Growth Faltering; Birth Outcomes; Uganda

Outcome Measures

Primary Outcomes (4)

• Infant Birth Weight

  Low birth weight \< 2500 grams

  Measured within 48 hours of delivery

• Infant Birth Length

  Measured within 48 hours of delivery

• Infant Gestational Age at Birth

  Preterm birth \<37 weeks gestation

  Measured within 48 hours of delivery

• Infant Head Circumference

  Measured within 48 hours of delivery

Study Arms (1)

Pregnant Women in Mukono Uganda

Single-group study

Other: Exposures of interest: Maternal EED and Aflatoxin Exposure

Interventions

Exposures of interest: Maternal EED and Aflatoxin Exposure OTHER

Maternal EED, measured via lactulose: mannitol (L:M) ratios and serum concentrations of antibodies to the bacterial components flagellin and lipopolysaccharide (LPS); Maternal aflatoxin exposure, measured via serum concentration of AFB1-lysine adduct

Pregnant Women in Mukono Uganda

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant women aged 18-45 years who visited Mukono Health Center IV in Mukono, Uganda for their first prenatal visit and who qualified for the study based on inclusion/exclusion criteria were invited to join the study until enrollment target was met.

You may qualify if:

• Carrying a singleton pregnancy
• years old
• Residing within 10 kilometers of Mukono Town

You may not qualify if:

• Younger than 18 years old or older than 45 years old
• HIV-positive (verified via routine rapid HIV test conducted at first prenatal visit)
• Severely malnourished (defined as BMI \<16.0 kg/m\^2)
• Severely anemic (defined as Hb \<7 g/dl)
• Planning to move away from Mukono District prior to delivery

Sponsors & Collaborators

• Tufts University: lead
• United States Agency for International Development (USAID): collaborator
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

Mukono Health Center IV

Mukono, Uganda

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples, Urine samples

MeSH Terms

Conditions

Birth Weight

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shibani Ghosh, PhD

  Tufts University Friedman School of Nutrition Science and Policy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 12, 2018
• Study Start: February 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 12, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)