Maternal Determinants of HIV-exposed and HIV-unexposed Fetal Growth, Birth Outcomes and Early Infant Growth

Sponsors

Lead Sponsor: Cornell University

Source Cornell University
Brief Summary

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.

Overall Status Completed
Start Date April 2012
Completion Date July 2013
Primary Completion Date June 2013
Study Type Observational
Primary Outcome
Measure Time Frame
Maternal cachexia score Up to 1 month post-partum
Secondary Outcome
Measure Time Frame
Maternal anthropometric measures Up to 1 month post-partum
Fetal growth Up to 1 month post-partum
Pregnancy outcomes Up to 1 month post-partum
Early infant anthropometrics Up to 1 month post-partum
Enrollment 218
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Joann M. McDermid, PhD, RD Principal Investigator Cornell University
Location
Facility: Kisesa Health Centre
Location Countries

Tanzania

Verification Date

September 2013

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Pregnant women and infants

Description: HIV+ and HIV- pregnant women, HIV-exposed and HIV-unexposed infants, ARV-exposed and ARV-unexposed infants

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov