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

Completed

• Conditions: Pregnancy; Malnutrition; HIV; Cachexia

• Registration Number: NCT01647841
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-24
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-26
• Last Update Posted: 2013-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal cachexia score	Up to 1 month post-partum

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kisesa Health Centre; 🇹🇿 Kisesa, Tanzania