Maternal EED and Aflatoxin Birth Outcomes Study Uganda

Completed

• Conditions: Aflatoxins Toxicity; Inflammatory Response; Birth Weight; Pregnancy Preterm

• Registration Number: NCT03429257
• Lead Sponsor: Tufts University

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.

Detailed Description

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:

1. 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.

2. 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.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2018-02
• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-05
• Last Update Submitted: 2018-02-05
• Study First Posted: 2018-02-12
• Last Update Posted: 2018-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 258

Inclusion Criteria

• Carrying a singleton pregnancy
• 18-45 years old
• Residing within 10 kilometers of Mukono Town

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infant Gestational Age at Birth	Measured within 48 hours of delivery	Preterm birth \<37 weeks gestation
Infant Birth Weight	Measured within 48 hours of delivery	Low birth weight \< 2500 grams
Infant Head Circumference	Measured within 48 hours of delivery
Infant Birth Length	Measured within 48 hours of delivery

Trial Locations

Locations (1)

Mukono Health Center IV; 🇺🇬 Mukono, Uganda