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NCT Number: NCT03429257

Maternal EED and Aflatoxin Birth Outcomes Study Uganda

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Mukono Health Center IV

Mukono, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Infant Birth Weight

    Time frame: Measured within 48 hours of delivery

    Low birth weight < 2500 grams

  2. Infant Birth Length

    Time frame: Measured within 48 hours of delivery

  3. Infant Gestational Age at Birth

    Time frame: Measured within 48 hours of delivery

    Preterm birth <37 weeks gestation

  4. Infant Head Circumference

    Time frame: Measured within 48 hours of delivery

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • Harvard School of Public Health (HSPH)
  • United States Agency for International Development (USAID)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 12, 2018
Registry last updated
Feb 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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