Cachexia, HIV, Malnutrition, Pregnancy
Conditions
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.
Interventions
None listed
Sponsors
Cornell University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal cachexia score | Up to 1 month post-partum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal anthropometric measures | Up to 1 month post-partum | weight, height, mid-upper arm circumference, triceps skinfold, fundal height |
| Fetal growth | Up to 1 month post-partum | — |
| Pregnancy outcomes | 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 |
| Early infant anthropometrics | Up to 1 month post-partum | weight, length, head circumference, mid-upper arm circumference, triceps skinfold |
Countries
Tanzania
Outcome results
None listed