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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

218 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Pregnancy Malnutrition Cachexia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant women and infants

HIV+ and HIV- pregnant women, HIV-exposed and HIV-unexposed infants, ARV-exposed and ARV-unexposed infants

No interventions assigned to this group

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joann M. McDermid, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Locations

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Kisesa Health Centre

Kisesa, , Tanzania

Site Status

Countries

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Tanzania

Other Identifiers

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IRB 1111002615

Identifier Type: -

Identifier Source: org_study_id