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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Response; Birth Weight; Pregnancy Preterm; Aflatoxins Toxicity
• Intervention / Treatment: Other: Exposures of interest: Maternal EED and Aflatoxin Exposure

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 Type: Observational
• Enrollment (Actual): 258

Contacts and Locations

Study Locations

• Uganda
  • Mukono, Uganda
    • Mukono Health Center IV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant Women in Mukono Uganda; Single-group study	Other: Exposures 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: United States Agency for International Development (USAID); Harvard School of Public Health (HSPH)
• Investigators: Principal Investigator: Shibani Ghosh, PhD, Tufts University Friedman School of Nutrition Science and Policy

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 5, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Pregnancy; Uganda; Aflatoxin B1; Environmental Enteric Dysfunction; Birth Outcomes; L:M Test; Linear Growth Faltering
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: AID-OAA-L-10-00006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No