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

HIV Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647841
• Other study ID #: IRB 1111002615
• Status: Completed
• Phase: N/A
• First received: July 18, 2012
• Last updated: September 26, 2013
• Start date: April 2012
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardTanzania: National Institute for Medical Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cachexia
• HIV
• Malnutrition
• Pregnancy

Locations

Country	Name	City	State
Tanzania	Kisesa Health Centre	Kisesa

Sponsors (1)

Lead Sponsor	Collaborator
Cornell University

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal cachexia score		Up to 1 month post-partum	No
Secondary	Maternal anthropometric measures	weight, height, mid-upper arm circumference, triceps skinfold, fundal height	Up to 1 month post-partum	No
Secondary	Fetal growth		Up to 1 month post-partum	No
Secondary	Pregnancy outcomes	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	No
Secondary	Early infant anthropometrics	weight, length, head circumference, mid-upper arm circumference, triceps skinfold	Up to 1 month post-partum	No