- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01647841
Maternal Determinants of HIV-exposed and HIV-unexposed Fetal Growth, Birth Outcomes and Early Infant Growth
September 26, 2013 updated by: Cornell University
The purpose of this study is to understand how differences in the nutritional status and concentration of hormones and cytokines associated with cachexia in HIV+ and HIV- pregnant women living in a semi-rural and rural region of northern Tanzania affect fetal growth, pregnancy outcomes and early infant health and development.
The study hypothesis is that HIV+ women will have worse nutritional status and a greater degree of cachexia which will negatively impact fetal growth, pregnancy outcomes and early infancy health and development.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
218
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kisesa, Tanzania
- Kisesa Health Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
HIV+ and HIV- women and their infants attending a semi-rural clinic and/or rural dispensaries for their antenatal and early infancy care in north western Tanzania
Description
Inclusion Criteria:
- Informed consent provided by mothers, and parental consent on behalf of their infants
- Confirmed HIV status (HIV-1, HIV-2 or HIV-Dual seropositive or HIV-seronegative)
- Estimated gestational age between 12th and 34th weeks
- Stated intention to remain in the clinic catchment area ≥6 months post-partum
- Singleton birth
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Pregnant women and infants
HIV+ and HIV- pregnant women, HIV-exposed and HIV-unexposed infants, ARV-exposed and ARV-unexposed infants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maternal cachexia score
Time Frame: Up to 1 month post-partum
|
Up to 1 month post-partum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal anthropometric measures
Time Frame: Up to 1 month post-partum
|
weight, height, mid-upper arm circumference, triceps skinfold, fundal height
|
Up to 1 month post-partum
|
Fetal growth
Time Frame: Up to 1 month post-partum
|
Up to 1 month post-partum
|
|
Pregnancy outcomes
Time Frame: Up to 1 month post-partum
|
spontaneous abortion, stillbirth, preterm delivery, perinatal mortality (death within first 7 days), neonatal mortality (death within first 28 days), small for gestational age, intrauterine growth retardation, low birth weight
|
Up to 1 month post-partum
|
Early infant anthropometrics
Time Frame: Up to 1 month post-partum
|
weight, length, head circumference, mid-upper arm circumference, triceps skinfold
|
Up to 1 month post-partum
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joann M. McDermid, PhD, RD, Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
July 18, 2012
First Submitted That Met QC Criteria
July 19, 2012
First Posted (Estimate)
July 24, 2012
Study Record Updates
Last Update Posted (Estimate)
September 27, 2013
Last Update Submitted That Met QC Criteria
September 26, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 1111002615
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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