Birth WeightNCT03429257
Maternal EED and Aflatoxin Birth Outcomes Study Uganda
An observational study of Birth Weight and Pregnancy Preterm, run by Tufts University at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Weight, Pregnancy Preterm, Aflatoxins Toxicity
- What is being tested?
- Exposures of interest: Maternal EED and Aflatoxin Exposure
- How many people
- 258 participants
- Where
- 1 siteUganda
- Study dates
- 1 Feb 2017to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Carrying a singleton pregnancy
- 18-45 years old
- Residing within 10 kilometers of Mukono Town
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- Being tested
- Exposures of interest: Maternal EED and Aflatoxin Exposure
- Keywords
- Aflatoxin B1, Environmental Enteric Dysfunction, L:M Test, Pregnancy, Linear Growth Faltering, Birth Outcomes, Uganda
- Medical subject headings
- Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposures of interest: Maternal EED and Aflatoxin ExposureOther
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
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women in Mukono Uganda | Single-group study Receives: Other: Exposures of interest: Maternal EED and Aflatoxin Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Birth Weight
Low birth weight < 2500 grams
Measured: Measured within 48 hours of delivery
Infant Birth Length
Measured: Measured within 48 hours of delivery
Infant Gestational Age at Birth
Preterm birth <37 weeks gestation
Measured: Measured within 48 hours of delivery
Infant Head Circumference
Measured: Measured within 48 hours of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start1 Feb 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Harvard School of Public Health (HSPH)
- Responsible party
- Principal investigator, Shibani Ghosh, Tufts University
- Investigators
- Shibani Ghosh, PhD, Principal investigator, Tufts University Friedman School of Nutrition Science and Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429257
- Sponsor's protocol ID
- AID-OAA-L-10-00006
- Status last verified
- Feb 2018
- First submitted
- 5 Feb 2018
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Among Maternal Environmental Enteric Dysfunction, Aflatoxin Exposure, and Birth Outcomes: A Prospective Cohort Study in Mukono, Uganda
- ClinicalTrials.gov ID
- NCT03429257
- Acronym / sponsor ID
- AID-OAA-L-10-00006
- Keywords
- Aflatoxin B1, Environmental Enteric Dysfunction, L:M Test, Pregnancy, Linear Growth Faltering, Birth Outcomes, Uganda
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Harvard School of Public Health (HSPH)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women in Mukono Uganda | – | Other: Exposures of interest: Maternal EED and Aflatoxin ExposureSingle-group study |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Carrying a singleton pregnancy
- 18-45 years old
- Residing within 10 kilometers of Mukono Town
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposures of interest: Maternal EED and Aflatoxin ExposureMaternal 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 | Other | Pregnant Women in Mukono Uganda |
Primary outcome
Infant Birth Weight
Time frame: Measured within 48 hours of delivery
Low birth weight < 2500 grams
Infant Birth Length
Time frame: Measured within 48 hours of delivery
Infant Gestational Age at Birth
Time frame: Measured within 48 hours of delivery
Preterm birth <37 weeks gestation
Infant Head Circumference
Time frame: Measured within 48 hours of delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Birth Weight
Active, not recruitingObservational study
Effects of Transitional Circulation in ELBW Infants
Neonatal Prematurity, Hypotension
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Recruiting
Effect of Developmental Care on Very Low Birth Weight Infants
Intervention
Not yet recruitingPhase 1
Breast-milk Enema Administration to Stimulate Passage of Meconium
Breast-milk
RecruitingObservational study
Mother and Offspring's Nutritional Status -Pregnancy After Maternal Bariatric Surgery
Bariatric Surgery, Pregnency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shibani Ghosh, PhD principal investigator
Tufts University Friedman School of Nutrition Science and Policy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Birth Weight and Pregnancy Preterm, run by Tufts University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Birth Weight (time frame: Measured within 48 hours of delivery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.