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Maternal EED and Aflatoxin Birth Outcomes Study Uganda

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03429257
Enrollment
258
Registered
2018-02-12
Start date
2017-02-01
Completion date
2017-12-01
Last updated
2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aflatoxins Toxicity, Birth Weight, Inflammatory Response, Pregnancy Preterm

Keywords

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

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.

Interventions

OTHERExposures of interest: Maternal EED and Aflatoxin Exposure

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

Sponsors

United States Agency for International Development (USAID)
CollaboratorFED
Harvard School of Public Health (HSPH)
CollaboratorOTHER
Tufts University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Infant Head CircumferenceMeasured within 48 hours of delivery
Infant Birth WeightMeasured within 48 hours of deliveryLow birth weight \< 2500 grams
Infant Birth LengthMeasured within 48 hours of delivery
Infant Gestational Age at BirthMeasured within 48 hours of deliveryPreterm birth \<37 weeks gestation

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026