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

September 26, 2013 updated by: Cornell University
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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kisesa, Tanzania
        • Kisesa Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pregnant women and infants
HIV+ and HIV- pregnant women, HIV-exposed and HIV-unexposed infants, ARV-exposed and ARV-unexposed infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maternal cachexia score
Time Frame: Up to 1 month post-partum
Up to 1 month post-partum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal anthropometric measures
Time Frame: Up to 1 month post-partum
weight, height, mid-upper arm circumference, triceps skinfold, fundal height
Up to 1 month post-partum
Fetal growth
Time Frame: Up to 1 month post-partum
Up to 1 month post-partum
Pregnancy outcomes
Time Frame: 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
Up to 1 month post-partum
Early infant anthropometrics
Time Frame: Up to 1 month post-partum
weight, length, head circumference, mid-upper arm circumference, triceps skinfold
Up to 1 month post-partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joann M. McDermid, PhD, RD, Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 18, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (Estimate)

July 24, 2012

Study Record Updates

Last Update Posted (Estimate)

September 27, 2013

Last Update Submitted That Met QC Criteria

September 26, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • IRB 1111002615

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malnutrition

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