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

This study is currently recruiting participants.
Verified March 2013 by Cornell University
Sponsor:
Information provided by (Responsible Party):
Cornell University
ClinicalTrials.gov Identifier:
NCT01647841
First received: July 18, 2012
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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


Estimated Enrollment: 208
Study Start Date: April 2012
Estimated Study Completion Date: July 2013
Estimated 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

Contacts
Contact: Joann M. McDermid, PhD 607-255-2490 jmm585@cornell.edu

Locations
Tanzania
Kisesa Health Centre Recruiting
Kisesa, Tanzania
Contact: Joann M McDermid, PhD     607-255-2490     jmm585@cornell.edu    
Sponsors and Collaborators
Cornell University
Investigators
Principal Investigator: Joann M. McDermid, PhD 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: March 11, 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 May 19, 2013