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

July 18, 2012
September 26, 2013
April 2012
June 2013   (final data collection date for primary outcome measure)
Maternal cachexia score [ Time Frame: Up to 1 month post-partum ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01647841 on ClinicalTrials.gov Archive Site
  • 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
  • Maternal anthropometric measures [ Time Frame: Up to 1 month post-partum ] [ Designated as safety issue: No ]
  • 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 ]
  • Early infant anthropometrics [ Time Frame: Up to 1 month post-partum ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Maternal Determinants of HIV-exposed and HIV-unexposed Fetal Growth, Birth Outcomes and Early Infant Growth
Not Provided

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • HIV
  • Pregnancy
  • Malnutrition
  • Cachexia
Not Provided
Pregnant women and infants
HIV+ and HIV- pregnant women, HIV-exposed and HIV-unexposed infants, ARV-exposed and ARV-unexposed infants
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
218
July 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT01647841
IRB 1111002615
No
Cornell University
Cornell University
Not Provided
Principal Investigator: Joann M. McDermid, PhD, RD Cornell University
Cornell University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP