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

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.

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Key information

Conditions

HIV Body Weight Body Weight Changes Cachexia Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pregnancy Signs and Symptoms Thinness Weight Loss

Sex eligibility

All sexes

Study type

Observational

Primary location

Kisesa Health Centre

Kisesa, Tanzania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Maternal cachexia score

Time frame: Up to 1 month post-partum

Secondary outcomes

Maternal anthropometric measures

Time frame: Up to 1 month post-partum

weight, height, mid-upper arm circumference, triceps skinfold, fundal height
Fetal growth

Time frame: 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
Early infant anthropometrics

Time frame: Up to 1 month post-partum

weight, length, head circumference, mid-upper arm circumference, triceps skinfold

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jul 24, 2012
Registry last updated: Sep 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed