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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cornell University
ClinicalTrials.gov Identifier:
NCT01647841
First received: July 18, 2012
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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.


Condition
HIV
Pregnancy
Malnutrition
Cachexia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Cornell University:

Primary Outcome Measures:
  • Maternal cachexia score [ Time Frame: Up to 1 month post-partum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maternal anthropometric measures [ Time Frame: Up to 1 month post-partum ] [ Designated as safety issue: No ]
    weight, height, mid-upper arm circumference, triceps skinfold, fundal height

  • Fetal growth [ Time Frame: Up to 1 month post-partum ] [ Designated as safety issue: No ]
  • Pregnancy outcomes [ Time Frame: Up to 1 month post-partum ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    weight, length, head circumference, mid-upper arm circumference, triceps skinfold


Enrollment: 218
Study Start Date: April 2012
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant women and infants
HIV+ and HIV- pregnant women, HIV-exposed and HIV-unexposed infants, ARV-exposed and ARV-unexposed infants

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

HIV+ and HIV- women and their infants attending a semi-rural clinic and/or rural dispensaries for their antenatal and early infancy care in north western Tanzania

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647841

Locations
Tanzania
Kisesa Health Centre
Kisesa, Tanzania
Sponsors and Collaborators
Cornell University
Investigators
Principal Investigator: Joann M. McDermid, PhD, RD Cornell University
  More Information

No publications provided

Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01647841     History of Changes
Other Study ID Numbers: IRB 1111002615
Study First Received: July 18, 2012
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board
Tanzania: National Institute for Medical Research

Additional relevant MeSH terms:
Cachexia
Malnutrition
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Nutrition Disorders

ClinicalTrials.gov processed this record on April 17, 2014