Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
Study NCT ID:
NCT03429257
Status:
COMPLETED
Last Update Posted:
2018-02-12
First Post:
2018-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maternal EED and Aflatoxin Birth Outcomes Study Uganda
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001724', 'term': 'Birth Weight'}], 'ancestors': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum samples, Urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 258}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-05', 'studyFirstSubmitDate': '2018-02-05', 'studyFirstSubmitQcDate': '2018-02-05', 'lastUpdatePostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infant Birth Weight', 'timeFrame': 'Measured within 48 hours of delivery', 'description': 'Low birth weight \\< 2500 grams'}, {'measure': 'Infant Birth Length', 'timeFrame': 'Measured within 48 hours of delivery'}, {'measure': 'Infant Gestational Age at Birth', 'timeFrame': 'Measured within 48 hours of delivery', 'description': 'Preterm birth \\<37 weeks gestation'}, {'measure': 'Infant Head Circumference', 'timeFrame': 'Measured within 48 hours of delivery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aflatoxin B1', 'Environmental Enteric Dysfunction', 'L:M Test', 'Pregnancy', 'Linear Growth Faltering', 'Birth Outcomes', 'Uganda'], 'conditions': ['Birth Weight', 'Pregnancy Preterm', 'Aflatoxins Toxicity', 'Inflammatory Response']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nIn 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.\n\nThe specific aims of this study were as follows:\n\n1. 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.\n2. 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Carrying a singleton pregnancy\n* 18-45 years old\n* Residing within 10 kilometers of Mukono Town\n\nExclusion Criteria:\n\n* Younger than 18 years old or older than 45 years old\n* HIV-positive (verified via routine rapid HIV test conducted at first prenatal visit)\n* Severely malnourished (defined as BMI \\<16.0 kg/m\\^2)\n* Severely anemic (defined as Hb \\<7 g/dl)\n* Planning to move away from Mukono District prior to delivery'}, 'identificationModule': {'nctId': 'NCT03429257', 'briefTitle': 'Maternal EED and Aflatoxin Birth Outcomes Study Uganda', 'organization': {'class': 'OTHER', 'fullName': 'Tufts University'}, 'officialTitle': 'Association Among Maternal Environmental Enteric Dysfunction, Aflatoxin Exposure, and Birth Outcomes: A Prospective Cohort Study in Mukono, Uganda', 'orgStudyIdInfo': {'id': 'AID-OAA-L-10-00006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant Women in Mukono Uganda', 'description': 'Single-group study', 'interventionNames': ['Other: Exposures of interest: Maternal EED and Aflatoxin Exposure']}], 'interventions': [{'name': 'Exposures of interest: Maternal EED and Aflatoxin Exposure', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Pregnant Women in Mukono Uganda']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mukono', 'country': 'Uganda', 'facility': 'Mukono Health Center IV', 'geoPoint': {'lat': 0.35333, 'lon': 32.75528}}], 'overallOfficials': [{'name': 'Shibani Ghosh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts University Friedman School of Nutrition Science and Policy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}, {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Assistant Professor', 'investigatorFullName': 'Shibani Ghosh', 'investigatorAffiliation': 'Tufts University'}}}}