Maternal EED and Aflatoxin Birth Outcomes Study Uganda

Study Overview
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Brief Summary
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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.

Detailed Description
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The problem of stunting, which has long-term health and economic consequences both at the individual and population level, persists in low and middle income countries (LMICs). It has been recognized that an estimated 20% of stunting begins in-utero. Although poor maternal nutrition during pregnancy is often blamed, it has been hypothesized that maternal EED status and maternal aflatoxin exposure during pregnancy may also play a role. However, to date, there have been no studies which have attempted to show the association between EED in pregnant women and negative birth outcomes. Furthermore, few studies have examined the association between maternal aflatoxin exposure during pregnancy and negative birth outcomes. In this prospective cohort study, pregnant women were enrolled at their first prenatal visit and birth outcome data was assessed within 48 hours of delivery. EED was measured via lactulose: mannitol (L:M) ratios and serum concentrations of antibodies to the bacterial components flagellin and lipopolysaccharide (LPS). Aflatoxin exposure was assessed by measuring the serum concentration of AFB1-lysine adduct from a blood sample taken at enrollment. Data on covariates were obtained from two surveys, one at enrollment and one three weeks prior to participant's estimated date of delivery. The specific aims of this study were as follows: To evaluate the relationship between markers of EED in pregnancy and negative birth outcomes, including low birth weight, stunting at birth, small head circumference, and premature delivery. To evaluate the relationship aflatoxin B1 exposure in pregnancy and negative birth outcomes, including low birth weight, stunting at birth, small head circumference, and premature delivery.

Official Title
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Association Among Maternal Environmental Enteric Dysfunction, Aflatoxin Exposure, and Birth Outcomes: A Prospective Cohort Study in Mukono, Uganda

Conditions
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Birth Weight, Pregnancy Preterm, Aflatoxins Toxicity, Inflammatory Response

Intervention / Treatment
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* Other: Exposures of interest: Maternal EED and Aflatoxin Exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Carrying a singleton pregnancy 18-45 years old Residing within 10 kilometers of Mukono Town Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant Women in Mukono Uganda<br>Single-group study | Other: Exposures of interest: Maternal EED and Aflatoxin Exposure<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aflatoxin B1, Environmental Enteric Dysfunction, L:M Test, Pregnancy, Linear Growth Faltering, Birth Outcomes, Uganda