Maternal Determinants of HIV-exposed and HIV-unexposed Fe... | NCT01647841

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

NCT01647841

Sponsor

Cornell University

Status

Completed

Last Update Posted

Sep 27, 2013Estimated

Enrollment

218Actual

Phase

Not provided

Conditions

HIV
Pregnancy
Malnutrition
Cachexia

Interventions

Not provided

Countries

Tanzania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Jun 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jul 18, 2012

First Submission Date that Met QC Criteria

Jul 19, 2012

First Posted Date

Jul 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2013

Last Update Posted Date

Sep 27, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

218Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant women and infants		HIV+ and HIV- pregnant women, HIV-exposed and HIV-unexposed infants, ARV-exposed and ARV-unexposed infants

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Maternal anthropometric measures	weight, height, mid-upper arm circumference, triceps skinfold, fundal height	Up to 1 month post-partum
Fetal growth		Up to 1 month post-partum

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joann M. McDermid, PhD, RD	Cornell University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kisesa Health Centre		Kisesa			Tanzania

Condition Browse Module

MeSH Terms

ID	Term
D044342	Malnutrition
D002100	Cachexia

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D015431	Weight Loss
D001836	Body Weight Changes

Browse Leaves

Not provided

Browse Branches

Not provided