Clinical trial NCT03429257: Maternal EED and Aflatoxin Birth Outcomes Study Uganda
Official title: Association Among Maternal Environmental Enteric Dysfunction, Aflatoxin Exposure, and Birth Outcomes: A Prospective Cohort Study in Mukono, Uganda
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Birth Weight
Pregnancy Preterm
Aflatoxins Toxicity
Inflammatory Response
Keywords: Aflatoxin B1
Environmental Enteric Dysfunction
L:M Test
Pregnancy
Linear Growth Faltering
Birth Outcomes
Uganda
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Harvard School of Public Health (HSPH)
First posted: 2018-02-12
Enrollment: 258
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Infant Birth Weight
timeFrame: Measured within 48 hours of delivery
measure: Infant Birth Length
timeFrame: Measured within 48 hours of delivery
measure: Infant Gestational Age at Birth
timeFrame: Measured within 48 hours of delivery
measure: Infant Head Circumference
timeFrame: Measured within 48 hours of delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Mukono
country: Uganda
facility: Mukono Health Center IV
Study officials:
affiliation: Tufts University Friedman School of Nutrition Science and Policy
name: Shibani Ghosh, PhD
role: PRINCIPAL_INVESTIGATOR
References: