Birth OutcomesUBCNCT04233944

Uganda Birth Cohort Study

An observational study of Birth Outcomes and Stunting, run by Tufts University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 15 to 49 years, women only
Conditions the study is for: Birth Outcomes, Stunting, Wasting
How many people: 5,044 participants
Where: 1 siteUnited States
Study dates: 15 Nov 2014to 4 Nov 2016
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 15 to 49 years
Women only
Child, Adult

Study population: Pregnant women, children under two years, and their households in Northern and Southwestern Uganda during 2014-2016

Who may be able to join

Participant is a woman aged 15-49 years
Participant intends to reside in the study area through the enrollment period
Participant provides informed consent herself or through a legal guardian
Pregnancy is confirmed by urine pregnancy test
Mother is aged 15-49 years
Mother intends to reside in the study area through completion of follow-up
Mother intends to deliver in the study area
Mother provides informed consent (potentially as an emancipated minor)

Who cannot join

-None

Trial locations and contacts

1 site in 1 country.

United States1 site

Tufts University
Boston, Massachusetts, 02111

Other trials in United States

About this study

Official title: Effectiveness of Integrated Livelihood and Nutrition Interventions to Improve Maternal and Child Nutrition and Health in Rural Uganda: A Birth Cohort Study

The UBC was a USAID-funded longitudinal prospective cohort study of pregnant women (n= 5030) aged 15-49 years from rural North and South-Western regions of Uganda, conducted between 2014 and 2016. The aim of the UBC study was to observationally follow pregnant women and their newborns until 2 years of age and compare changes over time in communities that were part of an ongoing USAID project called the Community Connector (CC) compared to those communities that were not included in the Community Connector project.

Read the detailed description

This study aimed to assess the role of livelihoods, agriculture and nutrition in improving maternal and child nutrition and health in rural Uganda in communities that were a part of an ongoing program that was un-related to the study. The overall aim of this study was to understand the effect of participating in an ongoing program that provided support on nutrition, agriculture, water, hygiene and sanitation and the change over time in the nutritional status of mothers and children under two years of age. The specific objectives of this observational study were as follows:

To compare health and nutrition status of pregnant women in communities participating in the Community Connector project to those that were not participating in the program
To assess the aflatoxin levels in pregnancy and test its association with birth outcomes and early life growth as measured by weight and length
To assess environmental enteropathy in pregnancy and test its association with birth outcomes and early life growth
To assess access to coverage and adherence to information/messages and engagement in Community Connector project's activities
To determine heterogeneity in program exposure and variability in household and agro-ecological characteristics and its relationship with maternal and infant health and nutrition status

Conditions: Birth Outcomes, Stunting, Wasting, Anemia
Keywords: Birth Outcomes, Pregnancy, Aflatoxin, Environmental Enteric Dysfunction (EED), Growth, Stunting, Wasting, Uganda, Anemia
Medical subject headings: Growth Disorders, Cachexia, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04233944
Study group	Role	What they receive
Pregnant women and their infants		Mothers and their infants were followed throughout the first two years of the infant's life. Data were collected at enrollment, birth, 3, 6, 9,12, 18 and 24 months from the date of delivery.

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of infants who were stunted
Percent of infants with a height-for-age less than -2 standard deviations
Measured: 0-2 years old
Percent of infants who were wasted
Percent of infants with a weight-for-height less than -2 standard deviations
Measured: 0-2 years old
Percent of infants who were underweight
Percent of infants with a weight-for-age less than -2 standard deviations
Measured: 0-2 years old
Infants' weight at birth (kg)
Birth weight in kilograms using a seca scale, calculated as the mean of three repeated measurements on each infant
Measured: Birth
Percentage of infants with low birth weight
Percentage of infants with birth weight less than 2500 grams
Measured: Birth
Percentage of preterm births
Percentage of infants born with a gestational age less than 259 days
Measured: Birth
Percentage of infants who were small-for-gestational-age
Percentage of infants at birth whose weight centiles were below the 10th percentile for their age and sex
Measured: Birth
Head circumference measurement (cm)
Infant's head circumference measured in centimeters
Measured: 0-2 years old

Secondary outcomes (5)

Percent of mothers that were anemic (hemoglobin levels <11 g/dL)
Percentage of maternal anemia defined by hemoglobin levels <11 g/dL, measured using the HemoCue test.
Measured: through study completion, every 3 months
Percent of infants that were anemic (hemoglobin levels <11 g/dL)
Percentage of infants with anemia defined by hemoglobin levels <11 g/dL, measured using the HemoCue test.
Measured: 0-2 years old
Concentration of ferritin (ug/L) in mothers and infants as a biomarker for iron status
Maternal and infants' serum ferritin (ug/L) measured using a sandwich enzyme-linked immunosorbent assay technique (ELISA) at the VitMin Lab in Germany
Measured: 6 months for infants, mothers at birth
Concentration of soluble transferrin receptor (mg/L) in mothers and infants as a biomarker for iron status
Maternal and infants' serum soluble transferrin receptor (mg/L) measured using a sandwich enzyme-linked immunosorbent assay technique (ELISA) at the VitMin Lab in Germany
Measured: 6 months for infants, mothers at birth
Concentration of retinol binding protein (umol/L) in mothers and infants as a biomarker for vitamin A status
Maternal and infants' serum retinol binding protein (umol/L) measured using a sandwich enzyme-linked immunosorbent assay technique (ELISA) at the VitMin Lab in Germany
Measured: 6 months for infants, mothers at birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 20144 Nov 2016

First posted18 Jan 2020
Study start15 Nov 2014
Primary completion4 Nov 2016
Study completion4 Nov 2016

Why it stopped: Funding constraints

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Birth OutcomesStudies 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: 5,044 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04233944
Sponsor's protocol ID: 11302
Acronym: UBC
Status last verified: Jan 2020
First submitted: 11 Jan 2020
Last updated: 18 Jan 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified data will be publicly available by the end of 2020

Publications

Mezzano J, Namirembe G, Ausman LM, Marino-Costello E, Shrestha R, Erhardt J, Webb P, Ghosh S. Effects of Iron and Vitamin A Levels on Pregnant Women and Birth Outcomes: Complex Relationships Untangled Using a Birth Cohort Study in Uganda. Matern Child Health J. 2022 Jul;26(7):1516-1528. doi: 10.1007/s10995-022-03387-5. Epub 2022 Mar 3.
PubMed 35239084
Madzorera I, Ghosh S, Wang M, Fawzi W, Isanaka S, Hertzmark E, Namirembe G, Bashaasha B, Agaba E, Turyashemererwa F, Webb P, Duggan C. Prenatal dietary diversity may influence underweight in infants in a Ugandan birth-cohort. Matern Child Nutr. 2021 Jul;17(3):e13127. doi: 10.1111/mcn.13127. Epub 2021 Feb 17.
PubMed 33595899

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of a Telerehabilitation-Supported, Family-Centered Early Intervention Program on Neurodevelopmental and Parental Outcomes in Infants at Mild-to-Moderate Risk
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All Birth Outcomes trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Integrated Livelihood and Nutrition Interventions to Improve Maternal and Child Nutrition and Health in Rural Uganda: A Birth Cohort Study
ClinicalTrials.gov ID: NCT04233944
Acronym / sponsor ID: UBC / 11302
Conditions: Birth Outcomes, Stunting, Wasting, Anemia
Keywords: Birth Outcomes, Pregnancy, Aflatoxin, Environmental Enteric Dysfunction (EED), Growth, Stunting, Wasting, Uganda
Study type: Observational
Recruitment status: TerminatedReason stopped: Funding constraints
Enrolment: 5,044 participants (actual)
Lead sponsor: Tufts UniversityUniversity, hospital or other
Collaborators: United States Agency for International Development (USAID), Makerere University, Harvard University
Study start: 15 Nov 2014 (actual)
Primary completion: 4 Nov 2016 (actual)
Study completion: 4 Nov 2016 (actual)
First posted: 18 Jan 2020 (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.

Detailed description

To compare health and nutrition status of pregnant women in communities participating in the Community Connector project to those that were not participating in the program
To assess the aflatoxin levels in pregnancy and test its association with birth outcomes and early life growth as measured by weight and length
To assess environmental enteropathy in pregnancy and test its association with birth outcomes and early life growth
To assess access to coverage and adherence to information/messages and engagement in Community Connector project's activities
To determine heterogeneity in program exposure and variability in household and agro-ecological characteristics and its relationship with maternal and infant health and nutrition status

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Pregnant women and their infants	–	–Mothers and their infants were followed throughout the first two years of the infant's life. Data were collected at enrollment, birth, 3, 6, 9,12, 18 and 24 months from the date of delivery.

Who may qualify

Ages: 15 to 49 years
Sex: Female only
Age groups: Child, Adult
Study population: Pregnant women, children under two years, and their households in Northern and Southwestern Uganda during 2014-2016

Key inclusion criteria (8 listed)

Participant is a woman aged 15-49 years
Participant intends to reside in the study area through the enrollment period
Participant provides informed consent herself or through a legal guardian
Pregnancy is confirmed by urine pregnancy test
Mother is aged 15-49 years

Key exclusion criteria (1 listed)

-None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percent of infants who were stunted
Time frame: 0-2 years old
Percent of infants with a height-for-age less than -2 standard deviations
Percent of infants who were wasted
Time frame: 0-2 years old
Percent of infants with a weight-for-height less than -2 standard deviations
Percent of infants who were underweight
Time frame: 0-2 years old
Percent of infants with a weight-for-age less than -2 standard deviations
Infants' weight at birth (kg)
Time frame: Birth
Birth weight in kilograms using a seca scale, calculated as the mean of three repeated measurements on each infant
Percentage of infants with low birth weight
Time frame: Birth
Percentage of infants with birth weight less than 2500 grams
Percentage of preterm births
Time frame: Birth
Percentage of infants born with a gestational age less than 259 days
Percentage of infants who were small-for-gestational-age
Time frame: Birth
Percentage of infants at birth whose weight centiles were below the 10th percentile for their age and sex
Head circumference measurement (cm)
Time frame: 0-2 years old
Infant's head circumference measured in centimeters

5 secondary outcomes

Percent of mothers that were anemic (hemoglobin levels <11 g/dL)
Time frame: through study completion, every 3 months
Percent of infants that were anemic (hemoglobin levels <11 g/dL)
Time frame: 0-2 years old
Concentration of ferritin (ug/L) in mothers and infants as a biomarker for iron status
Time frame: 6 months for infants, mothers at birth
Concentration of soluble transferrin receptor (mg/L) in mothers and infants as a biomarker for iron status
Time frame: 6 months for infants, mothers at birth
Concentration of retinol binding protein (umol/L) in mothers and infants as a biomarker for vitamin A status
Time frame: 6 months for infants, mothers at birth

Results and safety

The study was stopped early (reason given: Funding constraints). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
Derived from this study: PubMed 35239084Mezzano J, Namirembe G, Ausman LM, Marino-Costello E, Shrestha R, Erhardt J, Webb P, Ghosh S. Effects of Iron and Vitamin A Levels on Pregnant Women and Birth Outcomes: Complex Relationships Untangled Using a Birth Cohort Study in Uganda. Matern Child Health J. 2022 Jul;26(7):1516-1528. doi: 10.1007/s10995-022-03387-5. Epub 2022 Mar 3.
Derived from this study: PubMed 33595899Madzorera I, Ghosh S, Wang M, Fawzi W, Isanaka S, Hertzmark E, Namirembe G, Bashaasha B, Agaba E, Turyashemererwa F, Webb P, Duggan C. Prenatal dietary diversity may influence underweight in infants in a Ugandan birth-cohort. Matern Child Nutr. 2021 Jul;17(3):e13127. doi: 10.1111/mcn.13127. Epub 2021 Feb 17.
Individual participant dataSharing planned: Yes. De-identified data will be publicly available by the end of 2020

Related trials for Birth Outcomes

Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Active, not recruitingObservational study
Thailand Birth and Infant Outcomes Study
Outcome Assessment
Not yet recruiting
Effect of a Telerehabilitation-Supported, Family-Centered Early Intervention Program on Neurodevelopmental and Parental Outcomes in Infants at Mild-to-Moderate Risk
Development Delay, Motor Skills Disorders
Not yet recruiting
Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding Outcomes
Premature Birth, Infant, Premature

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.

Patrick Webb, PhD study director

Tufts, Friedman School of Nutrition

Shibani Ghosh, PhD principal investigator

Tufts, Friedman School of Nutrition

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 Outcomes and Stunting, run by Tufts University at 1 site in United States.

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 8 inclusion and 1 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: stopped early, as of the sponsor's last update on 18 Jan 2020. 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 United States. 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 was stopped early (reason given: Funding constraints). Results are not available in the source record.

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?

Percent of infants who were stunted (time frame: 0-2 years old). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04233944, which also lists 2 linked publications.

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 18 Jan 2020.